Rectus Muscle Sling Procedure for Severe Stress Urinary Incontinence

Type III stress urinary incontinence results from intrinsic dysfunction of the urethra and bladder neck incompetence. Effective repair must restore closure of the deficient urethra. Current surgical techniques include the use of fascial slings, vaginal island slings, artificial urinary sphincter, or periurethral injections. A variety of natural materials have been used for sling procedures, the most popular being fascia lata or rectus fascia. Synthetic materials are convenient but are more prone to problems of erosion or infection. The narrow dimensions of a traditional sling make it important that the surgeon position the sling accurately at the proximal urethra. A more distal location can produce outflow obstruction or problems with recurrent infection or voiding difficulty. The rectus muscle provides a broad platform of support for the bladder neck and urethra, and accurate placement seems to be less of a problem.

DIAGNOSIS

There is a clinical pattern of sacral neurogenic deficit that is characterized by flat feet and loss of intrinsic muscle function of the toes (inability to abduct the toes), and the lateral toes may be hypoplastic. On perineal examination, there is loss of two-point discrimination (4 cm) in the postanal (S5) or perianal (S4) dermatomes, and anal examination reveals loss of anal tone and anal grip that is weak and not sustained.

The severity of urinary leakage will give a clue to intrinsic urethral weakness. If the patient leaks with a flood in the supine position on the first or second cough, one should suspect type III stress urinary incontinence. Correction of bladder neck displacement with the examining finger will usually fail to correct the leakage. It is often difficult to assess urethral function in the presence of severe vaginal vault prolapse or procidentia because the prolapsing bladder base may obstruct the urethra. Surgical correction of the prolapse may reveal moderate or severe stress incontinence.

Objective urodynamic findings are essential to distinguish the patient who will require a sling procedure. Selection criteria for rectus muscle sling procedure were Valsalva leak-point pressures of less than 60 cm H2O and/or maximum urethral pressure (Brown and Wickam) of less than 20 cm H2O and/or a urethral length of less than 1.5 cm.

INDICATIONS FOR SURGERY

Traditional indications would reserve sling procedures for those who have failed a primary surgical repair. In contemporary practice, the sling is also used as a primary procedure for patients with severe stress urinary incontinence. Clinical features would include leakage with a flood that occurs instantly with the first cough in a supine position, in a patient with a comfortably full bladder, or leaks while standing without provocation.

Cystoscopic features include open bladder neck and short urethral length (<1.5 cm).

Patients who present with total vault prolapse with eversion of the vagina will also require a sling. It is my practice to identify and correct all of the pelvic support defects at the time of surgery.

ALTERNATIVE THERAPY

A variety of natural materials have been used for sling procedures, the most popular being fascia lata or rectus fascia. Synthetic materials are convenient but are more prone to problems of infection and erosion. The narrow dimensions of a traditional sling make it important that the surgeon position the sling accurately at the proximal urethra. A more distal location can produce outflow obstruction, problems with recurrent infection, or voiding difficulty. The artificial urinary sphincter or injection of periurethral bulking agents may be considered for the treatment of type III stress urinary incontinence.

SURGICAL TECHNIQUE

We have used a combined abdominal and vaginal approach. Venous compression pneumatic hose’s are applied and activated. The patient is placed in a modified dorsal lithotomy position with the lower limbs supported in the Sams modification of Allen stirrups. Independent grounding pads are placed for the abdominal and vaginal fields. Careful examination of the vagina and perineum confirms the presence or absence of fascial defects for repair. The most common defects are paravaginal, but anterior (pubocervical) or posterior (rectovaginal) fascial defects may also be present.

A midline incision is preferred, extending from the left of the umbilicus to the pubic crest. Alternatively, a transverse incision may be made, but this will require that the anterior rectus sheath be incised with a deep U incision and reflected upward to the level of the umbilicus. The rectus abdominis muscle is mobilized from the posterior aspect of the anterior rectus sheath, with care taken to preserve the epimysium, the outer fascial envelope that encloses the muscle bundles. This dissection progresses easily if the assistant elevates the fascial edge with Allis forceps and then Richardson retractors, and the surgeon works from the pubis toward the umbilicus. There are two small perforating vessels that pass anteriorly from the deep inferior epigastrics through the rectus abdominis muscle and the anterior rectus sheath to anastomose with the superficial epigastric vessels in the subcutaneous tissues. These perforators are coagulated and divided. At the lateral border of the rectus muscle, the segmental neurovascular bundles penetrate between the posterior and anterior layers of the rectus fascia; these bundles are coagulated, but the larger bundles may be ligated and divided.

Dissection to the lateral border of the muscle in the distal third allows the thin posterior fascia to be opened and the deep inferior epigastric pedicle to be palpated. If the pedicle has been ligated during an earlier procedure, the rectus muscle will be thin and not suitable, but the contralateral muscle can be used. If both pedicles have been ligated, the rectus muscle procedure would be abandoned, and a fascial sling substituted.

As dissection proceeds to the level of the umbilicus, a tendinous inscription will be noted where the anterior rectus fascia is adherent to the muscle. Above this level the direction of the fibers will change, and the muscle is mobilized for a further 2 cm cephalad to the tendinous inscription. The surgeon’s finger can now be passed from lateral to medial between the rectus muscle and the posterior rectus sheath. A large right-angle forceps is passed, and a heavy Vicryl ligature is carried around the muscle belly. As the ligature is tied, the muscle is divided, and the vascular pedicle is ligated. A second heavy ligature is tied, and the vessels are ligated and divided. Three holding sutures are placed through the tendon to facilitate the dissection and to be used later.

Dissection is continued until the muscle is free from all posterior attachments, and care is taken to clean all of the loose areolar tissue off the posterior rectus sheath to travel with the muscle; this will ensure that the vascular pedicle will be elevated with the muscle and preserved. The pubic insertion and the deep inferior epigastric vessels are not disturbed, but the muscle must be completely free from the overlying anterior rectus sheath and pyramidalis.

The muscle is held up by the holding sutures in the tendinous intersection and then folded along its longitudinal axis, by tying the lateral and medial holding sutures, to enclose and protect the vascular pedicle. The borders are approximated with two absorbable sutures in the middle third of the muscle.

The vaginal dissection is similar for other slings. The vaginal mucosa is elevated with injectable saline. We favor an inverted-U incision, but if access is narrow, a vertical incision is used. Dissection is carried out laterally to the pubic rami and forward under the bladder neck. The vaginal surgeon will elevate the endopelvic fascia, lateral and close to the pelvic side wall.

The abdominal surgeon will incise the endopelvic fascia and create an opening that will admit the passage of first one, and then two, fingers on the left side and then the right. The abdominal surgeon is usually able to guide the vaginal surgeon to avoid opening vaginal vessels, but on occasion the veins must be oversewn to control bleeding. Use of a spreading forceps (Knight Surgical Instrument Co.) allows the passage first of the holding sutures and then of the muscle belly through the ipsilateral defect to the vaginal surgeon. It is drawn downward to deliver the full length and then passed back into the pelvis through the other opening, while the spreading forceps within the pelvis hold open the defect in the endopelvic fascia. The tendinous inscription of the muscle is used to anchor the muscle sling to Cooper’s ligament with three or four nonabsorbable sutures. On occasion, the length of muscle will not reach up to Cooper’s ligament, and instead it will be secured to the internal obturator fascia.

The muscle belly fills the suburethral space and lies naturally without tension beneath the bladder neck and urethra. The suburethral muscle provides a broad support to the bladder neck and coaptation of the urethra. The vaginal wound is closed with interrupted absorbable sutures. If there are other support defects, the vaginal wound is closed first, before the colpopexy, and the paravaginal sutures from above (or the sacrocolpopexy fixation) are tied down.

Cystoscopy is done after intravenous injection of 5 ml of indigo carmine to confirm free efflux from the ureters. Cystoscopy is not used to adjust the sling but only to confirm the normal axis of the urethra and the closed appearance of the bladder neck. The bladder is drained with a urethral catheter. If there is a defect in the rectovaginal fascia or perineal body, this would be repaired after cystoscopy.

The abdominal wound is closed with interupted nylon sutures. Particular care is taken to close the fascia at the pubic crest.

The patient is mobilized on the first day. The catheter is drained to a bedside bag. It is removed when the patient has begun to pass flatus or had a bowel movement, usually on the third postoperative day. Voiding trials should begin at 3 hours, and after voiding efforts, straight catheterization should be done for residual volume. It is also necessary to drain the bladder one time in the course of the night in the first days. Most patients will require an interval of self-catheterization in the first 2 weeks, and some will use it for as long as 6 weeks. Preoperative teaching is done to encourage the transition through the interval of self-catheterization. When the catheterized volumes decrease to less than 60 ml, it can be tapered off. It is usually helpful to continue with the self-catheterization twice daily for a few days to be sure that emptying has been achieved.

OUTCOMES

Complication

Complications from this operation are few. Of 100 patients treated at our center since 1992, there was no mortality, and ten early complications included superficial wound infection (6), pelvic abscess (2), deep venous thrombosis (1), and fascial dehiscence (1). These complications all occurred early in the series, and some of these were related to the use of a suprapubic catheter. Special attention has been given to the surgical technique, including abandoning the use of suprapubic catheters, the introduction of antibiotic wound irrigation, and also the use of nonabsorbable sutures for the closure. There have been no wound problems in the last 26 cases.

There were 11 late complications including incisional hernia in nine. One patient had had multiple periurethral injections of Teflon, and the anterior vaginal wall was a solid indurated mass. After excision, the omentum was used to cover the muscle sling and repair the vaginal defect. This patient did well but developed prolapse of redundant omentum, which had to be trimmed after 6 months.

Results

One hundred patients have been treated for type III stress urinary incontinence with a rectus muscle sling since 1992. The medical record, patient interviews, and an independent questionnaire were used to evaluate the course and outcome of treatment. The interviews and questionnaires were done independently by a physician who was not a member of the surgical team. The mean age of the patients was 62 years, with a range of 24 to 83. The mean follow-up interval was 22 months, with a range of 3 to 47. Factors predisposing to incontinence included hysterectomy (79), lumbar stenosis (7), pelvic fractures (2), and traumatic paraplegia (1). Forty-nine patients had failed 86 previous surgical repairs, including MMK or bladder neck suspension (61), anterior repair (17), and periurethral collagen (8).

All patients had moderate or severe stress urinary incontinence, and all patients had preoperative videourodynamics. Selection criteria for rectus muscle sling procedure were Valsalva leak-point pressures of less than 60 cm H2O and/or maximum urethral pressure (Brown and Wickam) of less than 20 cm H2O and/or a urethral length of less than 1.5 cm.

Other anatomic defects were present in these patients, and other procedures were combined with the rectus muscle sling as needed. These procedures included sacrocolpopexy (34), paravaginal repair (31), and repair of urethrovaginal fistula (3).

The mean hospital stay was 6 days. On leaving hospital, 6% were already voiding to completion. Sixty-three were voiding but needed clean catheterization to empty, and 31% used a suprapubic catheter. After 2 months, 90% were voiding to completion, no patient had a suprapubic catheter, and only 10% used clean intermittent catheterization.

The pattern of voiding after a traditional sling may be slow or interrupted. It has been noticeable that voiding is quite normal for many of these patients after rectus muscle sling, and there are few complaints of irritative symptoms.

Of the 84 patients who responded to the independent questionnaire, 47% were dry and used no pads, and 33% were satisfied but were still using one or two pads a day. Twenty percent were not satisfied and still used 3 or more pads a day. Eighty-one percent of patients described themselves as improved or much improved after surgery.

This report represents a more complex group of patients than many series, because the majority had failed previous surgery, and no effort was made to exclude patients with risk factors of neuropathic disease, fistulas, or diabetes.

The rectus muscle flap is not difficult to develop, and the generous vascular pedicle is easy to protect during mobilization and transport of the flap. The muscle flap brings its own blood supply with it, providing excellent oxygenation for the healing tissues. This is an important consideration when dealing with complex problems of incontinence in patients who have had multiple surgical procedures or radiation therapy. This versatile flap may find many other applications in pelvic surgery.

Pelvic Floor Relaxation

A rectocele is secondary to a defect in the supporting fascia of the rectum that results in a herniation of the anterior rectal and posterior vaginal wall into the lumen of the vagina. The true incidence of rectoceles is unknown. Wells et al. reported a 12% incidence of rectoceles on physical examination when evaluating patients complaining of urinary incontinence.Concomitant rectocele or enterocele repair was performed in 35% of patients undergoing a Raz bladder neck suspension; however, 65% of patients who underwent repair of a grade IV cystocele required rectocele repair.

To understand the concepts underlying repair of pelvic floor relaxation, the anatomy of the normal pelvic floor support system should be briefly reviewed. The pelvic diaphragm is the superior shelf of the pelvic floor and consists of the levator ani and the coccygeus muscles. The urogenital diaphragm forms the second layer of the pelvic floor and consists of the bulbocavernosus, transverse perinei, and external anal sphincter muscles. These muscles join together with the anterior fibers of the levator ani to form the central tendon of the perineum.

The fascial support of the rectum consists of the prerectal fascia and the pararectal fascia. The prerectal fascia runs anterior to the rectum from the pouch of Douglas to the central tendon and prevents protrusion of the rectum into the vagina. A virtual space exists between the posterior vaginal wall and the prerectal fascia, which offers a convenient plane of dissection during rectocele repair. The pararectal fascia originates from the lateral pelvic sidewall and sweeps posteromedially to the rectum, splitting into anterior and posterior sheets and forming a fibrous envelope around the rectum.

The normal vaginal axis that is seen in the well-supported pelvic floor conveniently protects against rectocele formation and further pelvic prolapse. Two distinct areas of the vagina are seen if a normal vaginal axis is maintained. The proximal vagina lies at a 110- to 120-degree angle to the horizontal. The distal vagina, with the sling-like support provided by the levators, forms an angle of 45 degrees from the vertical. This results in a midvaginal angle of 110 to 130 degrees. In women with significant pelvic floor prolapse, levator plate laxity and widening of the levator hiatus result in a disappearance of the normal curvature of the vagina and a near-vertical vaginal axis, which facilitates rectocele formation.

The high incidence of concomitant rectocele and cystocele relates to the pathophysiology of pelvic floor weakness and subsequent rectocele formation. Childbirth results in several events that weaken the pelvic floor support system: (a) passage of the child’s head through the vagina stretches the prerectal and pararectal fascia and detaches the prerectal fascia from the perineal body; (b) the levator musculature and its fascia are weakened, which allows the levator hiatus to widen; (c) the normal narrowing of the vaginal opening is rendered ineffective secondary to widening of the anogenital hiatus and damage to the UG diaphragm.

The changes wrought by childbirth are further enhanced by aging, loss of estrogen stimulation, obesity, smoking, strenuous work/physical activity, and chronic abdominal straining, which is often seen in patients with chronic respiratory diseases and cough, constipation, and bladder outlet obstruction. Furthermore, loss of the normal vaginal axis, which is seen with pelvic floor relaxation (and may be accentuated after cystocele repair and/or anti-incontinence surgery), results in ineffective transmission of intra-abdominal pressures. This may lead to a worsening of preexisting pelvic prolapse and an increased risk of stress incontinence. Defects of the perineal body are often a result of injuries sustained during vaginal delivery or episiotomy.

DIAGNOSIS

The majority of rectoceles are asymptomatic. If symptomatic, rectocele-related complaints are often related to bowel dysfunction and include constipation, the need to digitalize the vagina to facilitate stool passage, a feeling of blockage at the outlet, and a sensation of stool pocketing. Interestingly, although problems with constipation are often correlated with a rectocele, many patients report continued difficulties with constipation after rectocele repair. Patients may also complain of dyspareunia and symptoms attributable to prolapse such as the feeling of a bulge or sitting on a ball. Defects of the perineal body are usually asymptomatic, but patients may complain of incontinence of liquid stool or flatus or loss of sensation during sexual intercourse secondary to a widened introitus.

The diagnosis of a posterior wall defect is made on physical examination. Examination of the posterior compartment is best accomplished using a Sims retractor or half of the vaginal speculum to displace the anterior vaginal wall anteriorly. Perineal body defects are associated with a widened introitus and a decreased distance between the anus and the posterior aspect of the vagina and are graded as follows: I, a tear in the hymenal ring; II, a tear involving the perineal body but not the anal sphincter; III, a tear involving the anal sphincter; IV, a tear extending into the anal mucosa. A rectocele will manifest as a bulge extending from the posterior wall of the vagina and is graded as follows: I, protrusion of the posterior vaginal wall at the level of the hymenal ring; II, protrusion at the level of the hiatus; III, protrusion beyond the introitus. Rectoceles may further be classified according to their position in the vagina as low, medium, or high. Rectovaginal examination will reveal attenuation of the fascia and helps rule out coincidental enterocele, which should be suspected in the patient with a high rectocele. With posterior wall defects, loss of the normal banana-like axis of the lower and upper vagina is seen, as the vagina will assume a straight orientation. Finally, defecography and dynamic rectal radiologic examinations are used by some authors in the diagnosis and classification of posterior vaginal vault defects.

INDICATIONS FOR SURGERY

Patients with symptomatic posterior vaginal wall defects should undergo surgical correction. The repair of asymptomatic defects coincident with other vaginal surgery is controversial. Arguments against repair of an asymptomatic rectocele include postoperative coital dysfunction and rectal injury. Jeffcoate described a 30% rate of discontinued coitus or dyspareunia after anterior and posterior repair3; however, recent reviews evaluating outcomes using present-day techniques describe a 0% to 9% incidence of coital dysfunction. Rectal injury has not been a concern with current surgical techniques.

Arguments favoring repair of asymptomatic pelvic floor relaxation during concomitant vaginal surgery include the risk of larger and symptomatic pelvic prolapse (i.e., rectocele, enterocele, uterine prolapse) if repair is not accomplished and the possibility that results of simultaneous anti-incontinence surgery are improved if repair is done. Anti-incontinence procedures orient the vagina in a vertical axis; however, pelvic floor relaxation repair helps restore the normal near-horizontal axis of the vagina. Restoration of this axis decreases the incidence of postoperative prolapse, results in more effective transmission of intraabdominal pressure to the pelvis, and should improve the results of anti-incontinence surgery by helping to provide a strong backboard against which the bladder neck and urethra (which are secondarily supported by the pelvic floor) can be compressed. These arguments, combined with the ability to accomplish this surgery without introducing significant perioperative morbidity, leads us to strongly favor simultaneous repair of even asymptomatic moderate pelvic floor weakness at the time of concurrent vaginal procedures.

ALTERNATIVE THERAPY

Alternatives to repair of pelvic floor relaxation include observation and intravaginal pessaries.

SURGICAL TECHNIQUE

The essential goals of rectocele repair include (a) plication of the prerectal and pararectal fascia, (a) narrowing of the levator hiatus by reapproximating the prerectal levator fibers;) repair of the perineal body.

Two days before surgery, the patient begins a clear liquid diet and begins oral laxatives. Broad-spectrum intravenous antibiotics to cover anaerobes, gram-negative bacilli, and group D enterococcus are administered preoperatively.

Positioning and Retraction

The patient is placed in the dorsal lithotomy position, and a Betadine-soaked rectal packing is placed to aid in identification of the rectum and to avoid rectal injury. The patient is draped (the rectal packing is isolated from the operative field with double draping), and a Foley catheter is placed. Anti-incontinence surgery, cystocele repair, enterocele repair, and vaginal hysterectomy, if indicated, are accomplished first. A ring retractor with hooks, applied to the perineum, aids in lateral exposure of the vaginal vault. The anterior vaginal wall is retracted upward with a Haney or right-angle retractor to improve visualization and help prevent excessive narrowing of the vagina.

Exposure of Perineal Body

The rectocele repair begins with the placement of two Allis clamps to the posterior margin of the introitus at the 5- and 7-o’clock positions. A V-shaped incision is made, and a triangular segment of perineal skin with the base of the triangle at the mucocutaneous junction is excised between the Allis clamps, exposing the attenuated perineal body.

Exposure of Distal Vaginal Defect

The Allis clamps are then placed in the midline of the posterior vaginal wall, grasping and elevating the rectocele at its midpoint. Saline is injected along the posterior vaginal wall to facilitate dissection. With the use of a scalpel, a second triangular incision is made in the posterior vaginal wall with the base of the triangle at the site of the previous incision and the apex of the triangle above the levator plate 2 to 3 inches inside the hymenal ring. This is a superficial incision through the vaginal wall only; a deeper dissection at this point risks injury to the rectum. Metzenbaum scissors are then used to sharply develop a plane from the lateral margins of the triangle, dissecting between the herniated rectal wall and the vaginal wall. Staying as close as possible to the vaginal wall to avoid injury to the rectum, the dissection extends laterally, exposing the attenuated prerectal fascia distally. The triangular island of posterior vaginal wall that was created by the inverted V-shaped incision is sharply excised off the prerectal levator fascia and fibers. This redundant skin is not discarded until the rectocele is entirely repaired; if the repair is accidentally too tight and/or excessively narrows the vagina, the excised piece of vaginal wall may be used as a free graft.

Exposure of Proximal Vaginal Defect

The prerectal fascia is exposed by sliding the Metzenbaum scissors under the posterior vaginal wall from the apex of the previous triangular incision to the cuff of the vagina. The posterior vaginal wall is then incised along the midline. This incision is made from the apex of the previous triangular incision to the vaginal cuff. An appropriately sized rectangular strip of posterior vaginal wall is excised (a greater severity of prolapse necessitates a wider resection of posterior vaginal wall), exposing the attenuated pararectal and prerectal fascia proximally. Use of a Haney or right-angle retractor on the anterior vaginal wall at this point helps prevent resection of an excessive amount of posterior vaginal wall, thus decreasing the risk of vaginal stenosis postoperatively. Inadequate resection of sufficient vaginal wall risks a weak repair and the formation of painful ridges during reconstruction.

Plication of Prerectal and Pararectal Fascia

At this point attention is turned toward repair of the rectocele. The anterior vaginal wall is retracted upward, and the distal rectum is retracted downward with a Haney or right-angle retractor. This protects the rectum, reduces the rectocele, and facilitates reapproximation of the pararectal and prerectal fascia. Reconstruction begins at the apex of the rectocele and is carried out to the level of the levator hiatus with a running, locking 2-0 polyglycolic acid suture. Each needle passage incorporates the edge of the vaginal wall and generous bites of the prerectal fascia and the pararectal fascia bilaterally. We attempt to reapproximate the sacrouterine/cardinal ligament complex with the initial bite of this portion of the repair to decrease the risk of subsequent enterocele formation.

Repair of the Levator Hiatus

Two or three interrupted figure-of-eight 2-0 polyglycolic acid sutures are placed, closing the distal posterior vaginal wall to the level of the perineum. This suture incorporates the same layers as previously described. As the reconstruction continues, each side of the vaginal wall should proportionally come together such that the most distal aspect of the repair, at the mucocutaneous junction, is reapproximated evenly. Reapproximation of the prerectal levator fascia at this level restores the normal axis of the vagina. Therefore, examination of the repair at this point should reveal a well-supported posterior vaginal wall with a concavity (corresponding to the normal midvaginal axis of 110 degrees) to the repair proximally. Finally, a smooth contour without ridges should be noted along the suture line.

Repair of the Perineal Body

Several vertical mattress sutures of 2-0 polyglycolic acid are used to approximate the bulbocavernosus, transverse perineal, and external anal sphincter muscles. This brings together the muscles of the UG diaphragm, reconstructing and providing support to the central tendon. The perineal skin is closed with a running 4-0 polyglycolic acid suture, and an antibiotic-impregnated vaginal packing is placed.

This procedure is performed as an outpatient surgery. The Foley catheter and vaginal packing are removed several hours after surgery, and patients are prepared for discharge within 6 to 20 hours postoperatively. Patients are sent home with oral antibiotics and are maintained on stool softeners for 1 month. Finally, patients are encouraged to resume early postoperative coitus to ensure normal resumption of sexual function.

OUTCOMES

Complications

Urinary retention is the most frequent complication of rectocele repair and occurs in 12.5% of patients. Retention in these patients is temporary and rarely lasts more than several days. Rectovaginal fistula was not seen in our series but has been reported in up to 5% of patients undergoing pelvic floor repair. Dyspareunia can be averted by not excessively narrowing the vagina, avoiding suture placement directly into the levators, and by not leaving uneven, painful ridges along the repair. Other complications of vaginal surgery include infection, bleeding, vaginal shortening, vaginal wall inclusion cyst formation, and fistula.

Results

Recurrent rectocele is very uncommon and has not occurred in any of the 95 patients we recently reviewed. However, recurrent pelvic prolapse can be expected in as many as 7.5% of patients postoperatively. Constipation is not resolved in up to 50% of patients undergoing rectocele repair for this complaint; this is likely a result of the multifactorial etiology of constipation in many patients.

Injections for Incontinence in Women and Men

In evaluating patients for the use of intraurethral injections as a treatment of urinary incontinence, it is essential to identify the cause(s) of incontinence in order to recommend appropriate therapy. Intraurethral injections benefit patients with incontinence occurring at the level of the bladder outlet. Incontinence occurring at this level may be caused by anatomic displacement of a normally functioning urethra (anatomic genuine stress urinary incontinence) in women or intrinsic incompetence of the urethral closure mechanism (intrinsic sphincteric dysfunction) in women or men. Patients with intrinsic sphincteric dysfunction (ISD) commonly have had a previous surgical procedure on or near the urethra, a sympathetic neurologic injury, or myelodysplasia. Female patients with genuine stress urinary incontinence have normal urethral function but hypermobility of the bladder neck and proximal urethra resulting from a deficiency in pelvic support. These patients benefit from bladder neck elevation and stabilization. Patients with ISD have poor urethral function and require procedures to increase outflow resistance. Patients with a fixed, well-supported urethra in association with ISD are excellent candidates for periurethral injection. In men this is most commonly encountered following radical prostatectomy, whereas in women the primary cause of ISD is a residual effect of multiple surgical resuspension procedures for genuine stress urinary incontinence.

DIAGNOSIS

Patients with ISD urodynamically display an open bladder outlet at rest in the absence of a detrusor contraction. However, standardization of a methodology to determine ISD has not yet been accepted. Because the incontinence of ISD is nonresistant (passive) urinary leakage, the goal of treatment should be only to coapt the urethra by passive occlusion. With respect to outlet function, maximum urethral closure pressure (UCPmax) obtained during urethral pressure profilometry has been the test used to determine the presence of ISD in women. Those women with UCPmax £ 20 cm H2O were said to have a “low-pressure urethra” or ISD, and these patients failed standard bladder neck suspension procedures.

One can infer that if urethral urinary loss can be induced by abdominal pressure, something must be wrong with the outlet. The abdominal leak-point pressure (LPPabd) is determined by direct measurement of the abdominal pressure required to overcome urethral resistance. This determination may be considered an indirect method of measuring the closure forces of the urethra during straining maneuvers. It is used primarily in women with stress urinary incontinence (SUI) to differentiate between anatomic displacement of a normal-functioning urethra (SUI caused by hypermobility) from poor outlet function (ISD). The leakage may be documented visually or fluoroscopically. At the point at which leakage occurs, LPPabd is recorded. Patients with ISD demonstrate minimal urethral resistance to straining, and therefore the urethral opening pressure is very low, whereas patients with an anatomic displacement of a normally functioning urethra have high urethral opening pressures, and therefore the LPPabd will be higher. However, no standardization of the technological methods to obtain LPPabd has been accepted. In summary, in evaluating leak-point pressures, until a universally accepted technique is established, a single mode with which the physician is comfortable should be used in the same manner on every patient whether for a preoperative evaluation or for the evaluation of a patient with an unsatisfactory result.

INDICATIONS FOR SURGERY

During the multicenter investigation of collagen in the treatment of ISD, the patients selected with anatomic (type II vesicourethral hypermobility) incontinence did not fare well. Therefore, the recommendation currently is to perform intraurethral or periurethral injections on patients with a poorly functioning urethra (ISD) and good anatomic support. However, recent data suggest that injectables may be used for selected female patients with anatomic stress urinary incontinence.

ALTERNATIVE THERAPY

The treatment of urinary incontinence related to the incompetent urethra has been a challenging problem and frequently involves surgical augmentation of intraurethral pressures by the use of slings made of autologous or synthetic materials, implantation of an artificial sphincter, or periurethral injection of bulk-enhancing agents.

SURGICAL TECHNIQUE

The technique of injection of material is not difficult; however, it is essential to perform precise placement of the material in order to ensure an optimal result. The equipment required for injection depends on the bulk-enhancing agent injected. The injection can be performed either suburothelially through a needle placed directly through a cystoscope (transurethral injection) or periurethrally with a needle inserted percutaneously and positioned in the urethral tissues in the suburothelial space, with the manipulation observed by cystourethroscopy. Men are injected predominantly by the transurethral approach, and women are injected by either technique. There is certainly a learning curve with any technique chosen, which ultimately results in using less injectable material to attain the desired result of continence. Injection techniques using glutaraldehyde-cross-linked collagen (Contigen) are presented, as this is currently the only injectable approved for incontinence.

Technique of Injection in the Male Patient

The patient is positioned in the semilithotomy position and prepped and draped in the usual fashion, and 10 ml of a 2% lidocaine jelly is placed intraurethrally and left in place 10 minutes before instrumentation. Cystourethroscopy with a zero-degree lens is employed. The injectable material is then delivered suburothelially by way of a transcystoscopic injection needle under direct vision. The needle is advanced under the mucosa with the beveled portion of the needle facing the lumen of the urethra. This is performed in a circumferential matter, employing four quadrant needle placements. The material is injected until a mucosal bleb is created in each quadrant. Gradually, after the circumferential injections, the urethral mucosa meets in the midline, although additional needle placements may be required for completion.

In cases of ISD following a radical prostatectomy, a short segment of urethra remains above the external sphincter. If visualization of this segment of the urethra is difficult, the needle may be placed at the level of the external sphincter and advanced to ensure deposition of the material proximal to the external sphincter. To be effective, any injectable material must be injected in the urethra superior to the external sphincter, even if this means injecting into the actual bladder neck on the proximal side of the anastomosis. It is important to note that the material should not be injected directly into the external sphincter, as this can cause pudendal nerve irritation with resultant sphincter spasm and discomfort. The depth of injection is also critical. The materials must deform the urethral mucosa so that it closes the urethral lumen. Too deep an injection site is a waste of the material and is not effective.

Injection is more difficult in patients with post-radical-prostatectomy incontinence resulting from the short segment of urethra above the level of the external sphincter and extensive scarring, which usually occurs in this area following surgery. This problem can be circumvented by using an antegrade approach. The technique is performed by passing a cystoscope with a 5-Fr working port through a small suprapubic cystotomy tract. The vesical neck and proximal urethra are then visualized, and subepithelial injections are performed until the bladder outlet is coapted. Frequently there is less scar tissue in this location, which results in better tissue coaptation. In early clinical trials, this technique seems to facilitate more precise injection of material, generating improved results with the use of less material.4 In the authors’ opinion this technique represents an exciting new method of implantation in male patients and should be considered in any postprostatectomy man not achieving adequate success by way of the standard transurethral approach. Post-radical-prostatectomy urothelium covers scar, and there is migration of any injectable substance distally along the urethra. Once this stops, there is a “wall” to abut the freshly injected material at the bladder neck. Therefore, this additional technique is not recommended as the primary method for an initial injection.

A small subset of patients continue to have some degree of incontinence after the placement of a bulbous urethral artificial urinary sphincter. To date the only options to address this problem have been to place a more distal second (tandem) cuff around the bulbous urethra or to place a higher-pressure regulating balloon. Injectable agents have generally been avoided in this setting because of fear of damaging the sphincter cuff. The antegrade approach can be used for this situation without fear of damaging the cuff, although it remains important to know the location of the pressure-regulating balloon before performing the punch cystotomy.

In cases of ISD following prostatic resection, a short segment of urethra remains below the veru montanum and yet is still proximal to the external sphincter. The injections should be made in this position circumferentially until urethral coaptation is visible. Extrusion of material into the urethral lumen from the needle holes may occur but can be minimized by not traversing the injected area with the distal end of the cystoscope once the material has been injected. In other words, do not enter the bladder.

Technique of Injection in the Female Patient

Women may be injected by way of a transcystoscopic technique, as described for the male patient, or by a periurethral approach. The patient is placed in the lithotomy position and prepped and draped in the usual fashion. The introitus and vestibule are anesthetized with 20% topical benzocaine, and the urethra is anesthetized with 10 ml of 2% lidocaine jelly. Following this, a local injection of 1% plain lidocaine is performed periurethrally at the 3- and 9-o’clock positions using 2 to 4 ml on each side. Panendoscopy is performed with a 0- or 30-degree lens, and the needle is positioned periurethrally at the 4- or 8-o’clock position with the bevel of the needle directed toward the lumen. The needle is then advanced into the urethral muscle into the lamina propria in an entirely suburothelial plane. Once the needle is positioned in the lamina propria, it usually advances with very little force. The needle may also be introduced between the urethral fascia and vaginal epithelium at the 6-o’clock position, and, again, needle placement is fully observed endoscopically. Bulging of the tip of the needle against the mucosa of the urethra is observed during advancement of the needle to ensure its proper placement. When the needle tip is properly positioned 0.5 cm below the bladder neck, the material is injected until swelling is visible on each side, creating the appearance of occlusion of the urethral lumen. Once the urethra is approximately 50% occluded, the needle is removed and reinserted on the opposite side, and additional material is injected until the urethral mucosa coapts in the midline, creating the endoscopic appearance of two lateral prostatic lobes.

Although urologists and urogynecologists are more familiar with transurethral than periurethral techniques, we prefer the periurethral approach, as this minimizes intraurethral bleeding and extravasation of the injectable substance. A useful “trick” described by Neal et al. is to add methylene blue to the injectable lidocaine to aid in the location of the needle tip before injecting the bulking agent.8 Once the needle is located at the bladder neck position, the syringe of anesthetic/methylene blue is removed, and the syringe containing the bulking agent is engaged. When the desired appearance of the coapted mucosa is attained, have the patient stand and cough to see if there is any leakage, and, if there is, reposition the patient and reinject.

Perioperative antibiotic coverage is continued for up to 3 days following the procedure. Most patients are able to void without difficulty following the procedure; however, if retention does develop, clean intermittent catheterization is begun with a 10- to 14-Fr catheter. An indwelling urethral catheter is to be avoided in patients, as this promotes molding of the material around the catheter. Although it is usually unnecessary, if longer-term catheterization is needed, suprapubic cystotomy should be performed in these patients.

Patients are contacted 2 weeks postprocedure in order to determine their continence status. Repeat injections are scheduled as necessary and at a time interval appropriate for the injectable substance.

OUTCOMES

Complications

The perioperative complications associated with periurethral injections are uncommon. In the multicenter clinical trial using Contigen injections, transient retention developed in approximately 15% of patients, but only 1% of patients experienced irritative voiding symptoms, and 5% developed a urinary tract infection. Hypersensitivity responses with Contigen are not a problem, as the possibility is assessed by skin testing (wheal and flare) with the more immunogenic and sensitizing non-cross-linked collagen prior to treatment. Those with a positive skin test are excluded from treatment. Regardless of the material, the use of periurethral injections has proven to be safe, eliciting only minor complications. All complications resolve rapidly, and a serious long-term complication from the use of periurethral injections has yet to be reported.

Results

There are no controlled, long-term reports available on any injectable. In fact, it is difficult to glean information in any group reported as to etiology of the incontinence. For example, in women results of injectables are reported without differentiating among patients with hypermobility, those with ISD, and those with both; and men with prostatic resection for benign disease are not separated from those having had a radical prostatectomy. Thus, results have been a combination of anecdotal reporting mixed with conjecture, speculation, and the hope that the truth is involved. Having stated this, it appears that injectables are helpful for some incontinent patients, especially selected women. There are two major disadvantages to the use of injectables: (a) the inability to determine the quantity of material needed for an individual patient and (b) the safety of nonautologous products for injection with respect to migration, foreign body reaction, and immunologic effects. At this point in time only Contigen has been approved as an injectable for incontinence in the United States, and results presented are confined to this approved substance.

Results of the North American Contigen Study Group of 134 postprostatectomy patients (17 postresection; 117 post-radical-prostatectomy) and 17 postradiation incontinent men demonstrated that only 22 men (16.5%) regained continence following injections of collagen, but 78.7% were dry or significantly improved at 1 year of follow-up, and 67% at 2 years following injections.2,7 Use of the antegrade injection technique in men failing the standard retrograde, cystoscopic approach increased the “cured” rate at 1 year by another 37.5%.

Results of the North American Contigen Study Group of 127 women demonstrated 46% dry and 34% socially continent (patients requiring a single minipad/day) with 77% remaining dry once continence had been attained. Worldwide independent studies have supported these findings. Patients with no anatomic hypermobility and ISD appear to be the most satisfactory candidates for intraurethral injections. In selected elderly and less mobile female patients with anatomic incontinence, recent data suggest that collagen may also be useful in this patient population.

Injectables are still in the developmental stages and their roles in the management of incontinence still need to be defined more precisely. Because the methods are less invasive and generally performed on an outpatient basis, medical costs should be reduced, and there should also be a more rapid return to the patient’s normal activities. The ideal material is still sought and should combine ease of administration with minimal tissue reaction, lack of migration, and persistence over time. The physician considering injectables for his or her patient should consider that there is a learning curve in patient selection as well as method of delivery of the bulking agents to attain optimal results.

Pubovaginal Fascial Slings

The first urethral sling procedure was described by Von Giordano in 1907. However, even after numerous technical improvements and application of many different materials, the pubovaginal sling (PVS) was rarely used until repopularized by McGuire and Lytton in 1978. The pubovaginal sling has traditionally been used only when other incontinence procedures such as a bladder neck suspension or retropubic urethropexy have failed. In this regard, patients with type 3 stress urinary incontinence, also called intrinsic sphincter deficiency (ISD), have often been diagnosed by default. More recently, the preoperative diagnosis of ISD has been facilitated by use of the Valsalva or abdominal leak point pressure (ALPP) during incontinence evaluations. Accordingly, the diagnosis of ISD can be made before surgery and a PVS performed as the primary incontinence procedure.

Stress urinary incontinence in females is classified by the presence and degree of urethral mobility and functional status of the urethra. In types I and II stress urinary incontinence, the urethral sphincter functions normally; however, abdominal pressure can drive the sphincter to a position where it doesn’t function normally. Stress incontinence due to urethral hypermobility can be successfully treated by a procedure that immobilizes it, such as a retropubic urethropexy or needle suspension procedure. Type III stress urinary tract incontinence, or ISD, is usually characterized by a minimally mobile urethra and incompetence of the urethral sphincter during increases in abdominal pressure. A few patients have incontinence due to coexisting ISD and urethral hypermobility. All patients with ISD are effectively treated with a PVS.

DIAGNOSIS

The preoperative evaluation is directed to identifying ISD. The history can be helpful because patients with ISD usually have severe leakage with minimal activity or have a history of irradiation to the pelvis, a prior incontinence procedure, or are elderly (especially new onset in patients over 70 years old). The incidence of ISD increases after each failed incontinence procedure: 9% if no previous surgery, 25% after one failed procedure, and 75% after two failed procedures.

The physical exam is directed to demonstrating leakage, urethral hypermobility, and pelvic prolapse. Urinary leakage without significant hypermobility constitutes presumptive evidence of ISD. A careful evaluation for associated cystocele, rectocele, enterocele, and uterine prolapse is important for ALPP interpretation and in planning the appropriate operative procedures. Failure to repair associated pelvic prolapse conditions will put undue stress on any incontinence procedure, including a pubovaginal sling, which increases the failure rate.

After the postvoid residual is determined, a cystometrogram is performed to exclude poor detrusor compliance and overt detrusor instability. To diagnose ISD, an ALPP is indispensable. The bladder is filled to a standard volume of 200 ml (children to one-half functional bladder capacity) and a slow Valsalva maneuver is performed with the patient in the upright position until leakage is noted. Performing this several times and determining an average improves accuracy. If a well-performed Valsalva maneuver fails to induce leakage, vigorous coughing may be required. If the ALPP is below 60 cm H2O, then ISD is present. If the ALPP is greater than 90 cm H2O and minimal pelvic prolapse exists, pure urethral hypermobility is usually present. Patients with a significant pelvic prolapse condition may have a falsely elevated ALPP and reduction with a vaginal pack is helpful. ALPP values between 60 to 90 cm H2O form a gray area in which hypermobility and ISD usually coexist.

INDICATIONS FOR SURGERY

The most common indications for a PVS are urodynamically documented ISD with or without urethral hypermobility and a prior failed incontinence procedure. Additionally, because of the long-term success and durability of a pubovaginal sling, certain patients with stress urinary incontinence due to urethral hypermobility may be better served with a sling procedure. These include females who engage in vigorous athletic activities, are significantly obese, or who cough frequently due to pulmonary disease.

ALTERNATIVE THERAPY

In selected female patients with ISD and minimal urethral hypermobility, collagen can be injected at the bladder neck with a success rate of 63% using a mean of 9.1 ml and 1.5 treatments. The vaginal wall sling introduced by Raz uses the in situ vaginal wall as the sling with a reported 93% short-term cure rate in patients with ISD.

SURGICAL TECHNIQUE

Patients with atrophic vaginitis should be treated with topical estrogens for 2 weeks before the procedure. It is helpful to teach the patient clean intermittent catheterization before the procedure since incomplete emptying is common for a few days postoperatively. One dose of intravenous antibiotics should be given preoperatively. General or regional anesthesia may be used without particular advantage to either technique.

The procedure is performed in the low lithotomy position using Allen stirrups with feet squarely in the stirrups to avoid pressure on the calf areas. The legs should only be moderately flexed at the hips to allow simultaneous exposure to the vagina and the lower abdomen. A 16-Fr Foley catheter is placed and the balloon inflated with 5 mls to allow palpation of the bladder neck and urethra. A weighted vaginal speculum is placed. The labia may be sewn laterally if the view is obstructed.

The rectus fascia is usually harvested first to minimize vaginal bleeding. In adults, an 8- to 10-cm Pfannenstiel incision is made approximately 2 to 3 cm above the pubis. The subcutaneous tissue is cleared from the rectus fascia and a relatively scar-free area is selected. Even the most scarred and thickened rectus fascia is usually suitable as a sling. Incising parallel to the fibers, obtain a fascial sling approximately 8 to 10 cm in length with a center portion 1.5 to 2.0 cm wide, tapering the ends to 1 cm wide. Free the upper and lower fascial leaf from the rectus muscles superiorly and inferiorly for approximately 4 to 5 cm to allow a tension-free fascia closure. The sling sutures may be placed before or after transection. The size and type of suture used is a matter of personal preference but we currently use 1-0 polyglactin absorbable suture, which decreases postoperative suture pain and does not compromise durability. The sutures are placed perpendicular to the direction of the fibers approximately 0.5 cm from the ends incorporating all of the fibers in the bites.

The vaginal procedure begins by placing an Allis clamp midway between the bladder neck and the urethral meatus with traction placed superiorly. It is very important to maintain this traction throughout the vaginal procedure. Injectable saline is infiltrated beneath the vaginal epithelium over the proximal urethra to facilitate the dissection. A 3-cm midline incision is made over the proximal urethra and the initial vaginal dissection is performed with a scalpel or Church scissors, which allows one to quickly find the proper plane superficial to the white periurethral fascia. Damage to the underlying urethra and bladder is minimized when dissection proceeds in this plane. The dissection is facilitated by maintaining outward traction (toward the operator) on the developing vaginal flap and by maintaining the tips of the scissors on this flap at all times. Carry the dissection laterally and enter the retropubic space inferior to the ischium, at the level of the bladder neck, by perforating the endopelvic fascia using curved Metzenbaum scissors with tips pointed laterally and slightly superiorly. Blunt finger dissection should not be used to perforate the endopelvic fascia as bladder injury may occur. Once the endopelvic fascia is entered, gently advance the closed scissors laterally and slightly upward for 1 to 2 cm before opening widely. Gentle blunt finger dissection of the retropubic space superiorly to the rectus muscle is performed (Fig. 40-3). Through the abdominal incision, the lateral border of the rectus muscle is retracted medially to expose a defect just lateral to where the rectus muscle inserts onto the symphysis. Gentle dissection in this area allows safe and easy access into the retropubic space. If finger dissection of the retropubic space is difficult, as is sometimes the case after prior procedures, place the tips of Metzenbaum scissors directly on the posterior pubis and slowly advance them with constant pressure against the pubic periosteum. After this is completed, no tissue should be palpable between fingers inserted into the retropubic space from above and the vaginal incision below. If some intervening tissue is found at the level of the pelvic floor, penetration of that tissue is safe. If the tissue is higher than the pelvic floor, it is often the bladder attached to the posterior pubis. The bladder can be carefully dissected off the pubis by keeping the scissors on the back of the pubis at all times. A similar procedure is performed on the other side. Extensive retropubic space dissection is unnecessary and may lead to excessive bleeding or bladder injury. A Sarot or Crawford clamp is placed in the retropubic space from above and directed into the vaginal incision using manual guidance. The tip of the clamp should remain in contact with the pubic periosteum and under the vaginal operator’s finger at all times. After clamps have been passed bilaterally, cystoscopy is performed to ensure there has been no damage to the urethra or bladder. Each sling suture is pulled into the abdominal incision placing the sling under the urethra. Proper function and longevity of the sling does not depend on the sutures to hold tension indefinitely (since the sutures are absorbable) and thus it is critical that a good portion of the sling extend into the retropubic space to allow good fixation. One or two 3-0 absorbable sutures are placed through the edge of the sling and superficially through the periurethral fascia to secure it in place. The sling sutures are passed through the rectus fascia, directly above the retropubic “tunnel,” using a right angle clamp before the rectus fascia is closed. If a suprapubic tube needs to be placed (we do not recommend this), it is done under direct vision at this time. The vagina is closed with a running, locking 2-0 absorbable suture. The weighted speculum and all other instruments should be removed from the vagina. The sling sutures are gently pulled up to remove any slack and tied over the rectus. A shodded clamp can be used to hold tension on the untied sutures until the appropriate tension is obtained. The appropriate tension is the minimum amount required to stop urethral motion, which is tested by pulling on the urethral catheter. Also, one or two fingers should easily slide under the suture knot. If in doubt it is better to err on the side of too little tension. We do not place a vaginal pack before tying the sutures. We have not found it useful to judge how tight to pull the sling by visual assessment during cystoscopy nor by tightening the sling until leakage cannot be produced by compressing the bladder. In the situation where the patient does not void and permanent urinary retention is desired, increased tension can be applied. The skin is closed and a vaginal pack placed. When the abdominal and vaginal components are performed synchronously, the average operating time is 40 minutes with 50 ml average blood loss.

On postoperative day 1, the vaginal pack is removed; if the patient is ambulating well, the Foley catheter is removed. The patient performs clean intermittent catheterization after each void, or a minimum of every 4 hours if unable to void, until the postvoid residual is consistently under 60 ml. Patients are regularly discharged within 48 hours. Oral antibiotics are not routinely prescribed postoperatively. Patients should refrain from vigorous activities and sexual intercourse for 4 to 6 weeks to allow proper fixation of the sling.

OUTCOMES

Complications

When rectus fascia is used for the urethral sling, the most common complications include detrusor instability and urinary retention. Approximately 15% to 25% of patients will have residual urgency symptoms, with less than half demonstrating occasional urge incontinence. Less than 10% will develop new onset detrusor instability. In a recent report by O’Connell and colleagues, 26% of patients had residual urgency symptoms and less than half of this group had mild urge incontinence. In most cases, these symptoms are responsive to anticholinergic medications and will subside over a period of 3 to 6 months.

Persistent postoperative urinary retention, although believed to be a common complication, is not statistically more common after pubovaginal slings than after suspension procedures. In a recent series of 54 patients, no patient who could void preoperatively was in persistent retention postoperatively. McGuire and colleagues reported a 3% incidence of prolonged retention in one series.

Superficial wound infections occur in approximately 4% of patients and significant blood loss occurs in 1% to 2%. Wound infections have not resulted in sling failure. Although synthetic sling materials may be used, relatively high rates of infection and urethral erosion have been reported. Persistent postoperative pain is rare when absorbable suture is used. O’Connell and colleagues reported that no patient had to take analgesics chronically and no patient had a procedure to relieve pain.

Results

In a recent series, 82% of patients were totally dry and another 11% had rare incontinence (once a week or less) for an overall 93% cured or significantly improved. Other long-term series have documented a greater than 80% cure and over 90% significantly improved rate. Residual stress incontinence usually responds very well to injectable agents such as collagen.

The pubovaginal fascial sling is the procedure of choice for treatment of females with urinary incontinence due to ISD. Even patients who had prior surgical failures can obtain excellent results with minimal morbidity, but such results are contingent on an accurate preoperative evaluation and careful placement of the sling at the proximal urethra without undue tension.

Anterior Vaginal Wall Sling

The Raz anterior vaginal wall sling is a relatively new surgical procedure developed since 1992 at the University of California Los Angeles Medical Center. It creates a sling for the treatment of intrinsic sphincter dysfunction (ISD) or anatomic (hypermobility-related) incontinence without burying vaginal epithelium or using autologous fascial strips. Permanent sutures are placed into the periurethral supporting tissues to create a hammock of support from the naturally occurring anatomic structures adjacent to the bladder neck and urethra. To achieve improvement in continence status, two main surgical goals must be met: (a) provide support and increased coaptation to the urethra and (b) create a strong hammock of vaginal wall and underlying tissues to provide a backboard of support to the midurethra and bladder neck during times of increased intra-abdominal pressure.

DIAGNOSIS

The presence of stress urinary incontinence should be confirmed objectively by the surgeon with physical examination, cystoscopy, and urodynamics. Epidemiologic studies have shown that 1% of patients who complain objectively of stress urinary incontinence actually have an alternative diagnosis such as profuse vaginal discharge or endocervical cysts, which may mimic incontinence. If incontinence can not be demonstrated objectively by the routine evaluation, then a pyridium pad test may be helpful in confirming the diagnosis. Before surgery, administration of a self-directed incontinence-specific quality-of-life score such as the Raz Quality-of-Life Score, the Incontinence Impact Questionnaire, or the Urogenital Distress Inventory will help to quantify the degree of clinical significance urinary incontinence is having on an individual patient.

Once incontinence is demonstrated, it is classified as intrinsic sphincteric dysfunction (ISD) or anatomic incontinence (AI). Because no pathognomonic test exists for ISD, the diagnosis is made by a combination of historical, physical, and urodynamic parameters. Factors typically associated with ISD include multiple prior surgeries, prior radiation exposure, direct urethral trauma, or neurologic dysfunction. The abdominal leak-point pressure is typically low. In contrast, patients with AI have hypermobility of the bladder neck and urethra, and the abdominal leak-point pressure is found to be higher than that in those with ISD. In addition to those patients who fit classically into either the ISD or AI categories, there exists a group of patients who may exhibit characteristics of both etiologies with an abdominal leak-point pressure in the gray zone between these two categories. Although patients with a broad range of intra-abdominal leak-point pressures have been treated with the anterior vaginal wall sling, we still continue to classify patients as ISD or AI types to aid in preoperative counseling. Patients with ISD may take longer to resolve postoperative urinary retention and have a lower incidence of resolution of preoperative instability symptoms than do patients with AI.

INDICATIONS FOR SURGERY

This procedure is indicated for clinically significant female stress urinary incontinence secondary to bladder neck hypermobility or intrinsic sphincter dysfunction with little (grade 1) or no cystocele. Like any vaginal surgery, it is contraindicated in patients who can not adequately be placed in lithotomy position because of physical restrictions such as limited hip abduction. Modifications of this procedure can be made to treat incontinence associated with grade 2 or 3 cystocele (six-corner suspension). Grade 4 cystocele requires a more extensive procedure in which both central and lateral defects are corrected.

ALTERNATIVE THERAPY

In contrast to the Raz vaginal wall sling, which uses permanent sutures placed in the periurethral supporting tissues, a sling can be created from a variety of alternative materials. These can be classified as endogenous sources (fascia lata, rectus fascia, or harvested strips of anterior vaginal wall) or exogenous sources. The latter are either synthetics such as Marlex mesh or natural sources such as banked human dura. In addition to sling procedures, ISD may be treated surgically with injectable agents (collagen, fat, Teflon, silicon) or the artificial urinary sphincter.

Alternative surgical treatments for anatomic or hypermobility-related incontinence are classified by the surgical approach—either abdominal, such as the Burch suspension, or vaginal, such as the Gittes or Stamey procedure. The Raz bladder neck suspension, which was previously used to treat anatomic incontinence, has now been replaced by the anterior vaginal wall sling at our institution.

SURGICAL TECHNIQUE

Preparation

In preparation for surgery, the patient should be given an oral stool softener to begin on the day before surgery. Broad-spectrum intravenous antibiotics such as an aminoglycoside plus a cephalosporin or a broad-spectrum DNA gyrase inhibitor are administered preoperatively.

Following general or spinal anesthesia, the patient is placed in the lithotomy position with the buttocks just overhanging the edge of the operating table. This will allow the weighted vaginal speculum to hang freely without contact against the operating table. The feet should be adequately padded in protective boots and placed in leg-supporting stirrups. If the patient is obese, slight Trendelenburg positioning of the table will help to expose the suprapubic region. The skin is then painted with an iodine-based solution from the level of the umbilicus inferiorly to include the whole perineum. The vagina is also painted with an iodine-based solution. A speculum or long forceps should be used to aid in the skin preparation of the vagina to ensure that the entire vagina is adequately prepared to avoid bacterial contamination of the suture material. The drapes are placed to expose the suprapubic region and perineum, with the anus carefully excluded from the field. Several 3-0 silk sutures are used to anchor the drape covering the anus to ensure that it does not fall away during the procedure, thereby contaminating the field.

To obtain maximum exposure, the 30-degree weighted vaginal speculum is placed in the vagina, following which single 3-0 silk labial retraction sutures are placed into the labia minora. Appropriate placement of these two retraction sutures will greatly aid in the exposure. Be sure they anchor the labia both laterally and superiorly to exposure the urethra and bladder neck region of the anterior vaginal wall. Always apply retraction sutures after the vaginal speculum is in place to avoid unnecessary tension or suture pull-out.

Suprapubic Cystostomy

A 14-Fr Foley catheter is used for suprapubic drainage. To place the suprapubic catheter, the closed curved Lowsley forcep is placed into the bladder by the surgeon and pressed against the anterior vaginal wall 2 cm above the symphysis pubis in the midline. The assistant feels for the tip of the forceps and makes a puncture wound with the scalpel blade cutting the skin and rectus fascia. The operator pushes the tip of the forceps through the wound, and the assistant positions the 14-Fr Foley catheter into the jaws of the retractor. Do not lubricate the tip of the catheter or curved Lowsley retractor to ensure that the catheter does not slip out of the jaws of the retractor. Withdrawal of the retractor by the surgeon delivers the tip of the catheter out the urethra. A small forceps is used to hold the tip of the catheter inside the bladder while the assistant inflates the balloon with 10 cc of water and irrigates with 50 cc of normal saline to ensure correct positioning within the bladder. The suprapubic catheter is placed on traction, and the bladder is emptied with the suction and clamped off. A second 14-Fr Foley catheter with 10 cc of water in the balloon is placed per urethra and clamped off. Palpation of the balloon against the bladder neck is helpful in identifying this landmark vaginally. The assistant places three Allis clamps at the level of the midurethra (midway between the bladder neck and external meatus) on the anterior vaginal wall and retracts upward, exposing the anterior vaginal wall for the surgeon.

Anterior Vaginal Wall Sling

Before the vaginal incisions are made, 10 cc of saline is injected just beneath the vaginal wall along the anticipated suture lines to facilitate dissection. Two oblique incisions are made in the anterior vaginal wall, extending from the level of the midurethra to 2 cm below the bladder neck. Dissection is carried out laterally using the Metzenbaum scissors to expose the vaginal side of the urethropelvic ligament bilaterally. This dissection should be superficial. Deep dissection with perforation of the ligament can result in excess bleeding. The attachment of the urethropelvic ligament to the tendinous arc can be felt by the operator by placing a finger into the incision pointing toward the ipsilateral shoulder of the patient. With gentle pressure, the curved Mayo scissors are placed into each wound against the tendinous arc and advanced until the retropubic space is entered. Opening the blades of the scissors helps to detach the urethropelvic ligament from the tendinous arc. The operator can now place a finger into the wound and feel the open retropubic space. Blunt finger dissection is used to detach any adhesions within the retropubic space from both sides. The space should feel freely open with the finger, and one should be able to palpate the urethra easily in the midline.

Two pairs of #1 Proline suture on a half-circle tapered MO-5 needle are used to complete the sling. As each suture is passed to the surgeon, its free end is held with a small mosquito forceps, which can rest on the patient’s abdomen while the surgeon completes suture placement. This keeps the free end of the suture well within the sterile field and prevents potential contamination.

Begin with placement of the proximal pair of Proline sutures, which are similar to those used in the traditional Raz bladder neck suspension. A long forceps is placed into the retropubic space, and the urethra and bladder are retracted medially. A #1 Proline suture is placed in a helical fashion into the urethropelvic ligament, taking several passes. Then, with the needle kept parallel to the plane of the vagina, the suture is passed in the vaginal wall (excluding the epithelium) to incorporate a large surface area of the underlying vesicopelvic fascia. A similar procedure is carried out on the contralateral side.

To place the second, more distal pair of Proline sutures, the long forceps is placed into the open retropubic space. Opening the jaws of the forceps parallel to the floor and retracting inferiorly will create an open triangle in the retropubic space. At the apex of this triangle is the levator muscle as it inserts into the pubic symphysis and the midurethral segment. The urethropelvic ligament in the medial vaginal wall forms the lateral border of the triangle. The floor of the triangle is parallel to the cardinal ligaments.

Using a #1 Proline suture, incorporate several passes of the levator muscle and the edge of the urethropelvic ligament. In order to obtain an adequate amount of levator tissue, the needle must be placed deep into the retropubic space. The levator should be visualized on the arc of the needle. Reposition the forceps to put downward traction on the anterior vaginal wall in the area of the midurethra and incorporate several helical bites of the underlying periurethral fascia incorporating tissue up to but not crossing the midline. As in placing sutures into the vesicopelvic fascia it is important to keep the needle parallel with the vaginal wall to prevent suture material from entering the spongy tissue of the urethra itself. After all four Proline sutures are in place, one can visualize a rectangle of support for the bladder neck and midurethra.

A clean blade is used to make a puncture wound the width of the double-pronged needle carrier in the midline, just above the superior margin of the pubic bone. If the incision is made too high, the sutures will be transferred over a mobile area of the anterior abdominal fascia, which can result in pain or incomplete support. The incision is carried down to, but not through, the rectus fascia. With a finger in the retropubic space serving as a guide, the double-pronged needle carrier is advanced through the suprapubic incision, the retropubic space, and out through the vaginal incision. As the needle passes into the retropubic space, it should hug the symphysis in the midline to ensure that the needle passes into the thick and less mobile area of the rectus fascia. The freed ends of one of the ipsilateral Proline sutures is placed through the needle holes in the double-pronged ligature carrier. Retraction of the needle carrier delivers both ends of the suture out through the suprapubic incision. A total of four passes are made, each suture being transferred individually. Do not attempt to transfer more than one suture at a time—this can result in tangling or knotting of the Proline sutures.

Indigo carmine is injected intravenously, and cystoscopy is performed with 30- and 70-degree lenses. This ensures that (a) the suprapubic tube is in good position, (b) blue efflux is noted from both ureteral orifices, (c) no Proline suture material has entered the bladder, and (d) upward retraction on the suprapubic Proline sutures provides support to the bladder neck and midurethra.

The urethral catheter is replaced, and the assistant provides upward retraction with the three Allis clamps, once again exposing the anterior vaginal wall. The two oblique incisions are closed with a running, locking absorbable suture of 2-0 polyglycolic acid on a tapered UR-5 needle. The shape of this needle allows better placement of sutures high in the vagina. A vaginal pack laden with antibiotic cream is inserted into the vagina, following which the weighted vaginal speculum is removed. Last, the Proline sutures are tied independently to their ipsilateral mates over the rectus fascia, creating the hammock of support . Excessive tension in the suspending sutures may lead to prolonged pain and is not necessary to achieve support. The skin edges of the suprapubic wound are freed, and the Proline knots are buried. Failure to adequately free the skin edges can result in dimpling of the skin over the Proline knots, which can cause patient discomfort. The suprapubic skin wound is closed with intradermic 4-0 absorbable sutures and Steri-strips.

Within 24 hours the vaginal pack and urethral catheter are removed. The suprapubic catheter is plugged, and the patient begins to record her voided volumes and the postvoid residual. The patient is discharged with an oral stool softener, an oral antibiotic, and analgesics. When the residual urine is consistently low, the suprapubic catheter is removed in the office.

OUTCOMES

Complications

The majority are preventable by (a) proper positioning of the patient, (b) careful dissection and identification of the important anatomic landmarks, and (c) routine performance of intraoperative cystoscopy for early identification and correction of potential problems. Patients at increased risk for complications include those with a history of prior bladder or pelvic surgery, endometriosis, pelvic infection, pelvic fracture, or significant pelvic prolapse. These factors may alter the typical pelvic anatomy. Although a detailed review of female pelvic anatomy is beyond the scope of this chapter, several excellent resources are available.

Intraoperatively, minor bleeding most commonly results from dissection in the wrong fascial plane, such as perforation of the urethropelvic ligament rather than dissection over its glistening surface during exposure. Bleeding may also occur following opening of the retropubic space if entrance is made too close to the urethra with subsequent injury to the periurethral vessels. Temporary placement of a pack into the retropubic space will facilitate exposure and provide hemostasis until a suture ligature can be applied. Temporary packing is always preferable to the excessive use of electrocautery on the delicate tissues of the urethra and bladder. Rarely, arterial vessels are found within the vaginal wall and are encountered shortly after the vaginal wall incisions are made. Should this occur, an Allis clamp placed over the edge of the vaginal wall will secure hemostasis until a suture ligature is applied. Postoperatively, vaginal spotting of blood may be noticed by the patient within the first two postoperative weeks. If vaginal bleeding continues or is increasing, perform a vaginal examination and place a temporary vaginal pack.

Misplaced Proline sutures occur when the anatomic landmarks are not clearly exposed and identified. This can potentially result in ureteral or bladder perforation or injury. Both of these complications may be diagnosed with the use of intraoperative indigo carmine and careful cystoscopy. If suture material is identified within the bladder, immediately remove the offending suture and ensure that the ureters are intact, performing retrograde pyelograms if necessary. Ureteral injuries may require stenting for minor injuries or reimplantation for complete ligations. Perforation of the bladder during dissection is exceedingly rare and should be repaired immediately intraoperatively by a multiple layered vaginal closure adhering to the principles of vesicovaginal fistula repair.

P>Postoperative suprapubic pain may be related to suspension sutures and is often activity related, subsiding with several weeks of decreased physical activity. It is often idiopathic in nature but may also be caused by cellulitis, subcutaneous abscess formation, muscle entrapment, vigorous overtying of sutures, or placement of sutures through a mobile portion of the anterior abdominal wall. Transferring of sutures in such a site may create tension over the rectus muscle during activity. Passing the double-pronged needle in the midline, as close to the pubic bone as possible, and not tying sutures under tension will minimize this complication.

Vaginal stenosis or shortening may result from excessive plication of the vaginal epithelium during closure or secondary scarring. When the vaginal wall is closed, the running suture is locked to aid in the prevention of excessive plication of the tissue. A history of new onset of dyspareunia or pelvic or vaginal pain and the finding of foreshortening on physical examination confirm the diagnosis. Mild shortening or stenosis may be treated with longitudinal relaxing incisions in the lateral vaginal wall with transverse closure.

Voiding dysfunction in the early postoperative period is common following surgery for stress urinary incontinence. Before surgery, the patient should be informed of common potential changes in her voiding pattern, including temporary retention and mild bladder irritability. The majority of patients with the new onset of voiding dysfunction have resolution of their symptoms within a short period of time; however, persistent voiding dysfunction should be reevaluated with physical examination, cystoscopy, and videourodynamics.

Urinary retention in the immediate postoperative period resolves in the majority of patients with the use of a suprapubic catheter or intermittent self-catheterization. Permanent retention has not been reported as a complication of this procedure.

Persistent or recurrent stress incontinence requires complete urodynamic evaluation and usually reoperation if it is of a severity to affect the patient’s quality of life. In this case, reoperation with proper suture placement should correct the problem. When the cause is recurrent intrinsic sphincteric dysfunction, alternative corrective measures including injection of urethral bulking agents or artificial urinary sphincters may be considered.

Pain, redness, and swelling in the suprapubic area should alert the surgeon to a potential infection at the site of suspension suture knots, which may require drainage should antibiotic therapy be unsuccessful. Lower urinary tract infections are common in the first month following any vaginal surgery and generally respond to a short course of oral antibiotics.

Results

In 1995 the clinical outcome of the sling procedure was reported in 163 women ranging in age from 31 to 81 years. The cohort was followed prospectively with a median follow-up of 17 months (range 6 to 32 months). Three patients were lost to follow-up. Of the 160, 95 had intrinsic sphincter dysfunction (ISD), and 65 anatomic incontinence (AI). One hundred fifty-two patients were considered cured of stress urinary incontinence at last follow-up. Eleven of 163 patients were considered failures and had recurrent incontinence that was unrelated to bladder instability and required further therapy. Time to recurrent stress incontinence comparing ISD and AI patients, as modeled using Kaplan–Meier survival curves and the log-rank test, showed no significant difference between patients with preoperative anatomic incontinence and those with intrinsic sphincter dysfunction (p > 0.05). Conditional logistic regression covariates revealed no significant predictive factors for postoperative failures. Seven percent of patients developed de novo instability. Pre- and postoperative within-patient changes of quality-of-life scores were found to be statistically significantly improved for both AI and ISD patients.

These initial results indicate that excellent continence was achieved in patients with both ISD and AI using the anterior vaginal wall sling. Advantages of this technique include the absence of a laparotomy incision, short hospital stay, lateral placement of permanent nonreactive sutures, and the ability to correct mild cystocele. The procedure has been shown to be safe and effective and allows for outpatient surgical management of bothintrinsic sphincter dysfunction and anatomic incontinence.

Abdominal Approaches to Surgery for Female Incontinence

Urinary incontinence in women is common. Its incidence rises after vaginal delivery, apparently as a result of nerve stretch, which can also occur after prolonged straining from constipation. Denervation can lead to incompetence of urethral and anal sphincters and to prolapse of the pelvic floor. Incontinence and prolapse are common and often, but not always, coexist. It is clear that for incontinence to occur, the urethral sphincter must be deficient whether or not a prolapse is present. In some patients with prolapse and bladder base descent, however, rotational compression of the urethra from the prolapse stops any leakage. Following repair of such prolapse, these patients might then begin leaking when the underlying intrinsic sphincter deficiency is unmasked.

The second major cause of urinary incontinence is detrusor instability, a diagnosis based on urodynamic studies and referring to the occurrence of detrusor contractions during the filling phase or provoked by coughing, posture change, etc. It is often associated with symptoms of frequency, nocturia, urgency, and urge incontinence. The presence of detrusor instability preoperatively has been demonstrated by some authors to have a negative prognostic influence on the outcome of surgery. The incidence of detrusor instability detected by continuous ambulatory monitoring is higher than that found on standard cystometry to the extent that some have considered it to be almost normal. In any case, where there are high-pressure overactive bladder contractions, these patients may well require a reduction in their bladder pressures by anticholinergic medication or, in severe cases, by augmentation cystoplasty to ensure adequate bladder capacity, particularly if there is a neurologic cause.

DIAGNOSIS

The diagnosis of urinary incontinence can be made by clinical history and examination of the patient with a full bladder, observing the effects of coughing and straining. The severity of urinary incontinence can be graded.

Urinary leakage can be quantified by standardized pad-weighing tests or by a bladder diary and can be further assessed by the performance of pressure-flow studies, preferably with video screening facilities to demonstrate bladder base and urethral hypermobility or rotational descent during coughing and straining. This will also outline any fistula or urethral diverticulum.

The type of urinary incontinence can be classified on the basis of radiologic findings and the degree of bladder base descent (anatomic incontinence) or whether the urethra appeared wide open as a “stove pipe” (intrinsic sphincter deficiency, ISD) in an attempt to rationalize the type of procedure to be advised.

Measurements of urethral pressures during coughing and straining and measurements of the pressure transmission ratio or assessment of the abdominal leak-point pressure during a Valsalva maneuver have been found useful by some clinicians. Low preoperative maximum urethral closure pressure (MUCP) is more likely to result in a postoperative failure to stop the leakage.1 The abdominal leak-point pressure (ALPP) correlates with the degree of incontinence from the history and from pad-weighing tests; however, the pelvic floor is a complex mechanism, and precisely what happens to it during straining and coughing requires further study.

The presence of detrusor instability is not easy to predict from the history of frequency, nocturia, urgency, and urge incontinence or from examination of the patient, and one must rely on urodynamic studies.

INDICATIONS FOR SURGERY

Essentially, if conservative measures have not succeeded, patients who have genuine stress incontinence and who are bothered by the symptom and who are fit for surgery should be offered it.

The significance of detrusor instability detected preoperatively in predicting the outcome of surgery is controversial. Many have shown that preoperatively detected detrusor instability compromises the results of surgery. Long-term ambulatory monitoring studies show a higher incidence of detrusor instability than conventional cystometry, and the detrusor instability correlated with an increased surgical failure. Many patients with detrusor instability lose their urgency and frequency symptoms postoperatively, though preoperative detrusor instability may persist in 15% to 89% of cases (mean approximately 50%).

Principles of Surgery

Continuous Compression of Urethra

Artificial urethral sphincters and injectable bulking agents produce a continuous compression of the urethra to stop leakage. Submucosal injections of bovine collagen, fat, silicone macroparticles, and other bulking agents have been used to produce coaptation of urethral walls and to increase urethral resistance to leakage; they seem to work best for ISD where there is minimal rotation of the bladder base.

Intermittent Compression

Exactly how other procedures work remains somewhat conjectural but is probably on the same principle of having a backboard behind the urethra that will prevent mobility during coughing and improve the pressure transmission ratio (PTR) of abdominal pressure to the urethra. There is no intrinsic change in the maximum urethral closure pressure postoperatively; hence, nothing is done to improve the efficiency of the intrinsic sphincter mechanism.

These operations produce a suburethral “sling”:

  • Of vaginal wall and periurethral tissues and endopelvic fascia in situ, as in the Stamey, Gittes, Burch, Marshall–Marchetti–Krantz (MMK), and Raz–Peryera operations
  • Of the vaginal wall as a buried strip as in the Raz vaginal sling
  • Using a strip of rectus fascia or fascia lata
  • Of synthetic materials

The principal difference among these procedures is whether the “sling” is sutured to a fixed point, as in the iliopectineal ligament of the Burch procedure and as in the symphysis pubis in the MMK procedure, or to the mobile rectus sheath, as in the pubovaginal sling, Stamey, and Raz operations. The theoretical advantage of being fixed to the mobile rectus sheath is that it will allow for a loose sling at rest that tightens when the abdominal pressure rises and hence resists leakage when it is needed without obstructing voiding.

ALTERNATIVE THERAPY

Conservative therapies including pelvic floor exercises, vaginal cones, and pelvic floor electrical stimulation achieve a success rate that varies between 30% and 70%.3 This improvement may avoid the need for surgery in some patients. It is usually worth trying as a first line of treatment. Success is less likely in the patient who has had previous surgery or radiotherapy and in those with grade 2 or 3 severity of leakage. Hormone replacement therapy may help frequency, urgency, and burning, but its use for incontinence has been disappointing.

SURGICAL TECHNIQUE: RETROPUBIC CYSTOURETHROPEXIES

Burch Colposuspension

Informed consent should follow only after a full explanation of the procedure, length of time of hospitalization and recovery, expected outcomes, and possible complications, as discussed below. Prophylactic antibiotics are administered. My preference is to use a cephalosporin with a spectrum against anaerobic organisms.

The fully anesthetized patient is placed in the modified Lloyd Davies position with hips abducted and minimally flexed. This allows access for preliminary cystoscopy if indicated and for bimanual manipulation intraoperatively. Skin preparation of the abdomen and vagina is performed using Betadine.

A 16-Fr urethral catheter with 7 ml instilled into the balloon is placed on free drainage. Through a Pfannensteil incision 1 cm above the symphysis pubis, the rectus fascia is incised transversely, and the recti are separated. The bladder is swept off the back of the symphysis pubis and the iliopectineal ligament, exposing it and the obturator internus and levator ani muscles. Care is required to avoid damage to the abnormal obturator veins, if present. This dissection is easy in a first approach but can be difficult if adhesions are present following previous surgery. Care is required to avoid perforating a thin-walled bladder adherent to the bones. Keeping close to the bone helps to avoid this. Some surgeons advocate intravesical installation of methylene blue to detect any transgression into the lumen.

With the two fingers of the operator’s left hand in the vagina, the lateral fornix is tented up, and the endopelvic fascia overlying the vaginal fornix, well lateral to the bladder, is buttonholed; this allows the vagina and its plexus of veins to be mobilized medially. The dissection should start well laterally to avoid the ureter and the bladder. Blunt dissection with the Riches diathermy forceps develops the appropriate plane lateral to the bladder neck as defined by palpation of the Foley catheter balloon, and this exposes the pale white tissue of the vagina and allows any venous bleeding to be cauterized without changing instruments. Mobilization is done on both sides. A row of usually three nonabsorbable sutures (size 1 nylon) are placed full thickness of vagina up through the iliopectineal ligament. These are then tied before sutures are placed on the opposite side to enable correct positioning.

It is important not to make the suspension too tight, and it is not necessary to approximate the vagina to the iliopectineal ligament. Often the sutures “bow-string,” particularly after previous vaginal repair or vaginal hysterectomy, as of course they always do in any of the needle suspension procedures.

Where an enterocele is present, this can be surgically managed with a Muskowitz procedure in which the pouch of Douglas is obliterated intraperitoneally by encircling sutures at serial levels. In the prevention of this complication of the Burch procedure, some have advised plication of the round ligament or, if a hysterectomy has been previously undertaken, of tightening the uterosacral ligaments.

A suction drain is left in the retropubic space, and a suprapubic catheter is inserted to enable measurements of postvoid residuals postoperatively. After balloon inflation, the catheter should be withdrawn against the vault of the bladder to avoid its tip irritating the trigone and causing postoperative urgency. The rectus muscles are approximated with interrupted 2-0 synthetic absorbable sutures without tension, and the rectus fascia is closed transversely with continuous 0 suture.

Postoperatively the suction drain is removed, usually by day 2; the suprapubic catheter is clamped, and a trial of voiding is commenced. It is removed when the residuals are less than 100 ml or less than one-third of the bladder capacity. Patients are discharged by day 5, and by then most are voiding satisfactorily; if there is any doubt, the patient is taught intermittent self-catheterization until voiding efficiency is restored.

Marshall-Marchetti-Krantz Procedure

This procedure, described in 1949, involves retropubic dissection through a Pfannensteil incision as for the Burch procedure, and the edges of the urethra are sutured to the fibrocartilage of the symphysis pubis. Serially, the row of sutures is continued onto the anterior surface of the bladder in the perception that this would alleviate prolapse and descent of the bladder base. There is some risk of damage to the urethra as the sutures pass through its lateral wall, and most surgeons have modified the original procedure to take in the periurethral tissue rather than the edges of the urethra. There are also technical difficulties in some patients because of the very thin periosteum through which to place the sutures.

Suburethral Slings

Patients with rotational descent and adequate vaginal capacity are suitable for either a Burch colposuspension or a pubovaginal sling, but if the vaginal capacity is reduced, a pubovaginal sling may be more appropriate. These retropubic procedures use a fascial strip from the rectus fascia as a suburethral sling with each end sutured to the rectus sheath. This technique has been largely superseded by a vaginal approach to avoid the retropubic . In the abdominal approach for this procedure, a strip of rectus fascia 1.5 cm wide is taken from the upper margin of the Pfannensteil incision. The bladder is mobilized, and a tunnel is developed between the vagina and bladder neck and upper urethra, using the balloon of the catheter as a guide. The sling is passed through this tunnel, each end of the strip is sutured with 1 nylon, and the sutures at each end are brought out and tied anterior to the rectus, 1 to 2 cm lateral to the midline, and low down, 1 cm above the symphysis. The length of the strip is probably not critical to the procedure, but it would seem reasonable to use a strip approximately 5 to 10 cm in length. The nylon sutures can be passed up to the appropriate site using the Stamey needle. It is important to ensure that the sling is not too tight, to avoid urethral compression.

Laparoscopic Burch Colposuspension

The patient is admitted in the morning of surgery, having had nothing by mouth from midnight of the night before. Below-knee compression stockings are fitted, and a shave is performed to just below the upper border of the pubic symphysis (midpubic shave). No bowel preparation is necessary for this procedure. A suitable premedication is given, and prophylactic antibiotics are given with the induction of anesthesia as a single dose.

A general anesthetic is preferred for complete relaxation. Pneumatic calf stimulators are placed once the patient is asleep. The low lithotomy position is employed with slight hip flexion and abduction. The lower abdomen and vagina are scrubbed and prepared in the usual manner, and a Foley catheter is placed on free drainage. Surgical drapes are placed to leave the abdomen below the umbilicus and perineum exposed. The surgeon stands on the patient’s left, and the assistant and a scrub nurse on the patient’s right. A Mayo table is placed between the patient’s legs, and this contains the trocars and instruments necessary during the procedure. Two video monitors are generally employed, one each for the surgeon and assistant, at the foot of the bed.

The procedure commences with a 12-mm incision, which is placed midway between the umbilicus and the pubic symphysis. It is extended down to the fascia, which is cleared away by finger dissection. The fascia is penetrated with a fine arterial forceps, and the surgeon’s index finger is used to clear the extraperitoneal space so that the pubic symphysis can be clearly felt. It is important to be careful not to puncture the peritoneum during this maneuver. Two stay-sutures are placed to the fascial opening; then the retroperitoneal dilating balloon on a catheter introducer is passed into the space created, and 600 ml of saline is placed in the balloon. This remains inflated for several minutes while the remainder of the laparoscopic instrumentation is set up, including the video camera. The balloon is then deflated, and the Hasson cannula placed and secured with stay-sutures. The space is then inspected with the laparoscope. The room is then darkened, and the light source turned up to the maximum. The remaining two trocars are placed in the left lower quadrant. It is important to avoid the vessels that are transilluminated during this maneuver. The 5-mm trocar is placed 2 cm above the symphysis at the lateral border of the left rectus abdominis muscle. The 10-mm trocar is placed between the two previous trocars avoiding obvious blood vessels.

With the assistant’s finger in the vagina elevating the tissue adjacent to the bladder neck, which can easily be identified using the balloon of the Foley catheter as a guide, the endopelvic fascia is cleared of its fatty tissue. The grasping forceps are in the surgeon’s left hand, and the endosurgical scissors in his or her right. Once this is completed, the needle holder is used to introduce the long length of 2-0 Ticron suture down the 10-mm port. The needle is grasped at an appropriate angle, and a large bite of this tissue adjacent to the bladder neck is obtained. The suture needle is then cut off. The percutaneous suture passer is then passed under direct vision into the extraperitoneal space just above Cooper’s ligament. It is then placed through the ligament. The end of the suture is passed through the eye of this needle and drawn up through the ligament. Then, the suture material is freed from the suture passer, and this is withdrawn. The free end of the suture, which now passes through both the vaginal tissue and Cooper’s ligament, is then grasped with the needle holder and drawn out through the 10-mm port. An extraperitoneal knot is then tied, and this is passed down to be placed snugly on Cooper’s ligament. The suture material is then cut, and two further intracorporeal knots are tied to secure this extracorporeal knot. The assistant’s finger elevates the tissues throughout this maneuver. Further fixation can be obtained with a 15-cm length of 2-0 Ticron suture on a needle that is passed through both Cooper’s ligament and the vaginal tissues with the knots being tied intracorporeally. The procedure is then repeated on the patient’s left side in an identical manner.

An alternative to this technique involves a 15-cm length of suture, which is prepared by tying a small loop at the free end. The suture is then passed through the 10-mm port with a needle holder and then through the tissue at the level of the bladder neck. The needle is then passed through this loop at the end of the suture, and it is snugged down onto the tissues. A further bite of paravaginal tissue can then be taken to form a helical suture, and the needle is then passed through Cooper’s ligament. A Lapra-Ty clip can then be placed onto the suture just as it exits the ligament. A second pass through Cooper’s ligament and a second Lapra-Ty clip can also be placed for extra security.

The patient is able to eat and drink once she recovers from the effects of the anesthetic. Analgesic and antiemetics are given as required, though opiates are usually unnecessary. The Foley catheter remains in the bladder on free drainage until 6 o’clock the next morning, at which time it is removed, and if the patient is able to void comfortably on several occasions following this, she is discharged from the hospital. Rarely, intermittent self-catheterization will be required for the first few days if voiding is not satisfactory. Residual urine volumes are not routinely measured. No further antibiotic prophylaxis is employed.

OUTCOMES

Complications

Urethral obstruction after successful surgery occurs in about 10% of cases. To prevent it, care should be taken to avoid elevating the bladder neck too high or tying sutures with undue tension. Intermittent self-catheterization is best used in these cases, and generally, with time, voiding dysfunction usually resolves within about a week. It may persist longer. If dysfunction persists for more than 3 to 6 months, the sutures can be taken down, and, following cystolysis, a vagino-obturator shelf can be considered.

Postoperative voiding difficulties may be predicted by preoperative voiding problems. However, some acontractile bladders at preoperative study can be shown to contract postoperatively. Those with low preoperative voiding pressures (less than 15 cm of water) were more likely to have problems.7 Measurement of isometric pressure at the clinical stop test was not found to be helpful in predicting postoperative voiding dysfunction.

De novo appearance of detrusor instability postoperatively has been observed in 10% to 20% of cases. Why this should occur is unclear, but ambulatory continuous monitoring studies show a higher preoperative incidence of detrusor instability, and perhaps the surgery unmasks this by changing afferent inputs from the pelvic floor. In the patient with urgency and urge incontinence postoperatively, one should exclude infection and obstruction. Urodynamic studies should be performed to determine the presence of instability. Cystoscopy should be undertaken where the problem persists, as occasionally a stitch will erode into the bladder. In management, if instability is the only problem, then anticholinergics are often helpful. In the rare cases where this does not suffice and instability remains a problem, then a clam cystoplasty can be considered.

Dyspareunia following pelvic floor surgery is not uncommon and is either downplayed or not included in the subjective symptomtology in most series. Where the vagina was narrow or shortened before the incontinence surgery, dyspareunia may occur as a result of the posterior ridge that mirrors the anterior suspension of the anterior vaginal wall. Usually this will settle in time.

The question of whether vaginal delivery should be allowed after a successful incontinence surgery is often stated, but the evidence is lacking. This has led to most patients who have had a successful outcome from surgery being advised by their obstetrician to consider a cesarean section rather than risk breaking it down. The magnitude of this risk has never been properly substantiated.

After the Burch procedure and needle suspension operations, pain occurs in around 10% and is usually caused by the tension of the sutures. Mostly it decreases with time, but occasionally it persists, and the sutures have to be removed. Another rarer cause of pain is osteitis pubis.

Results

There is a discrepancy between the results as told us by the patients and those obtained from objective tests of clinical examination, pad-weighing tests, or video pressure-flow studies postoperatively. Often it is not clear in the literature how the results are in fact assessed. In a collected series only 4,815 of 20,481 (23.5%) had had their results of surgery objectively assessed.

Results are probably best assessed by a health professional independent of the surgeon, as patients often unwittingly confound the results as stated. They often want to please the surgeon, the one whom they chose and whose advice they accepted. They might feel guilty about hurting the surgeon’s feelings or fearful that if they complain of continuing problems, the surgeon might want to do all that again, or even something worse. Patients often enhance the results, and although they may indeed be dry, that might be at the expense of stopping jogging, aerobics, or golf, etc. These factors make comparison of outcomes from different procedures quite difficult.

There is not a perfect operation for female urinary incontinence, but the results in achieving continence are quite good at 5 years. The results tend to diminish in time, although the Burch operation and pubovaginal slings tend to hold up as well as most others.

Patients with persistent or recurrent urinary incontinence should be thoroughly reassessed. This includes history, examination, bladder diary, pad-weighing tests, and urodynamic studies to detect any instability, fistula, etc. If genuine stress incontinence is the reason for failure, then the operation can be repeated. Or, if the urethra is “stove-pipe” and fixed, then there are the options of injecting a suburethral bulking agent such as collagen or of repeating the colposuspension or vaginal sling. In gross cases, some have advocated a reduction vesicourethroplasty. In some cases the artificial urethral sphincter can be considered.

Causes of failure include incorrect placement of sutures too high or too low in relation to the bladder neck, sutures cutting out, atrophy of the periurethral and vaginal tissues contributing to the sling, or sphincter damage as might occur in the Marshall–Marchetti–Krantz procedure, where the sutures might have been placed in the wall of the urethra. The urethra may be held open by scar tissue following the first procedure, and a full urethrolysis needs to be considered at the second procedure to avoid this.

A history of previous hysterectomy; obesity, but excluding morbid obesity; parity; or age had no apparent influence on the outcome, but results were slightly better in those who had no past history of prior incontinence surgery.

Stamey and Gittes Bladder Neck Suspension

STAMEY BLADDER NECK SUSPENSION

Suspension of the bladder neck via a vaginal approach was initially described by Peyrera in 1959. Contemporary techniques of transvaginal bladder neck suspension have arisen as modifications of Peyrera’s description. The endoscopic needle suspension of Stamey, described in 1973, contributed several concepts to the surgical technique of bladder neck suspension. This procedure was the first to utilize the cystoscope to precisely place sutures at the bladder neck and visualize closure of the bladder neck with elevation of the suspension sutures. In addition, the procedure incorporates a knitted dacron graft as a bolster to buttress either side of the urethra and aid in the prevention of suture pull-out.

Indications for Surgery

The technique described by Stamey is indicated for correction of stress incontinence in the absence of a significant cystocele. We currently have abandoned simple bladder neck suspensions and perform vaginal wall slings for patients with stress incontinence and no significant cystocele. The choice between these techniques depends on the surgeon’s training and experience with the different procedures.

Alternative Therapy

Alternatives to needle suspensions of the bladder for stress urinary incontinence include transabdominal suspensions, vaginal wall slings, fascial slings, periurethral injections of collagen or Teflon, and conservative measures such as pessaries, pelvic floor stimulation, behavior modification, biofeedback, a-agonist therapy, and urinary collection devices including pads or diapers.

Surgical Technique

Positioning and Retraction

The patient is placed in the dorsal lithotomy position and prepped and draped in the standard fashion. A posterior weighted vaginal speculum and silk labial retraction sutures are placed to aid in exposure. A Foley catheter is placed, and the bladder is drained.

Exposure of Bladder Neck

A T-shaped incision is made in the anterior vaginal wall. The dissection is carried down to the glistening periurethral fascia and continues laterally until the surgeon is able to palpate the balloon of the catheter. This identifies the bladder neck and allows adequate exposure for later placements of the dacron pledgets.

Needle Passage

Two suprapubic stab wound incisions are made on each side of the lower abdomen, and the anterior rectus fascia is exposed. The single-pronged Stamey needle is then inserted into the medial edge of one of the suprapubic wounds and advanced, under fingertip control, into the vaginal incision. The needle passes through the rectus fascia, adjacent to the periosteum, alongside the bladder neck, and through the periurethral fascia as it traverses from the abdomen to the vagina. The Foley catheter is removed, and cystoscopy is performed to confirm correct positioning of the needle. An appropriately positioned needle, when moved medially, will indent the ipsilateral bladder neck. If the needle penetrates the bladder, it should be removed and repassed.

Suture Transfer and Dacron Graft

One end of a #2 nylon suture is threaded through the needle and transferred suprapubically. The Stamey needle is passed a second time, 1 cm lateral to the first pass, and its position is again cystoscopically confirmed. The vaginal end of the nylon suture is threaded through a 10- by 5-mm dacron arterial graft, and the free vaginal end of the nylon suture is then placed in the needle holder and transferred suprapubically. During the transfer of this nylon, an Allis clamp may be used to visually maneuver the dacron graft into appropriate position at the urethrovesical junction as the Stamey needle is pulled suprapubically. The periurethral tissues are now suspended on one side of the bladder neck, and the procedure is repeated on the contralateral side.

Cystoscopy and Closure

Cystoscopy is performed to evaluate the placement of the needle sutures and to confirm adequate functional closure of the bladder neck with minimal tension placed on the nylon sutures. The vaginal incision and graft material are irrigated with an antibiotic solution and closed with a running, locking 2-0 polyglycolic acid suture. An antibiotic-impregnated vaginal pack is placed, and the suprapubic nylon sutures are tied, without tension, such that the knots rest against the rectus fascia. A suprapubic catheter is placed, and the suprapubic wounds are closed with a 4-0 polyglycolic acid suture following antibiotic irrigation.

The vaginal packing may be removed 2 hours after surgery, and the patient may be discharged as early as 6 hours postoperatively. The suprapubic catheter is removed no earlier than 1 week after surgery once the postvoid residuals are less than 60 ml.

Several important technical points have been outlined by Stamey. The dacron graft should be positioned below the suture line to prevent graft erosion through the vaginal incision. Copious irrigation with an aminoglycoside solution should be performed before closing the vaginal incision to decrease the risk of dacron graft infection. The appropriate Stamey needle (0-, 15-, or 30-degree angle at the distal end containing the needle) should be used depending on the patient’s anatomy.

OUTCOMES

Complications

Complications particular to the Stamey needle suspension include erosion of suture and bolster material into the urinary tract, which can occur up to 7 years following the procedure. Stamey reports a 0.3% incidence of dacron buttress erosion into the bladder as well as a 0.3% incidence of failure of the vaginal incision to completely heal, resulting in an exposed piece of dacron. In both circumstances the exposed tube and suture were removed (endoscopically if the tube eroded into the bladder), and continence was maintained with the single remaining suture on the contralateral side. Sutures are removed in 1% to 2% of patients for pain or infection, and long-term retention may be resolved by loosening of the nylon loop under local anesthesia.

Results

Evaluation of the literature to determine the success rates of this operation is difficult. The majority of the studies with an adequate number of patients obtained their data in a retrospective manner without anonymous questionnaires to the patients (thus possibly introducing bias to their results), the follow-up in most studies was short (mean follow-up often 24 months or less), and the definition of success was different from author to author (completely dry versus improved). These provisos should be remembered as the literature is reviewed.

Review of the English literature in the past 5 years reports cure rates that range from 53% to 80%. Walker and Texler evaluated patients with a mail-in questionnaire and found 82% of 192 respondents improved and 65% of patients willing to undergo the procedure again.10 Early success rates with the Stamey bladder neck suspension may not be durable. O’Sullivan et al. reported a dry rate of 70% immediately after surgery in 67 patients, which decreased to 31% dry at 1 year (58 patients) and further decreased to 18% dry at 5 years (22 patients).8 Mills et al. found the cure rate in 30 patients decreased from an initial 67% to 33% over a 10-year period of time. Factors that may place patients at increased risk for postoperative failure include obesity, respiratory disease, number of pads used per day, prior Marshall–Marchetti–Krantz procedure and concomitant abdominal hysterectomy.

GITTES NO-INCISION URETHROPEXY

The technique of Gittes and Loughlin was described in 1987. Their simplified modification of the Peyrera needle suspension obviates the need for vaginal incisions. This technique is based on the concept that as a monofilament suture pulls through the vaginal wall, it heals as an autologous pledget, creating an internal bolster that tethers the anterior vaginal wall and prevents rotational descent with Valsalva.

Indications for Surgery

The technique described by Gittes is indicated for correction of stress incontinence in the absence of a significant cystocele. We currently have abandoned simple bladder neck suspension and perform vaginal wall slings for patients with stress incontinence and no significant cystocele. The choice between these techniques depends on the surgeon’s training and experience with the different procedures.

Alternative Therapy

Alternatives to needle suspensions of the bladder for stress urinary incontinence include transabdominal suspensions, vaginal wall slings, periurethral injections of collagen or Teflon, artificial urethral sphincters, and conservative measures such as pessaries, pelvic floor stimulaion, and urinary collection devices including pads.

Surgical Technique

Positioning and Retraction

The patient is placed in the dorsal lithotomy position and prepped and draped in the standard fashion. A posterior weighted vaginal speculum and silk labial retraction sutures are placed to aid in exposure. A Foley catheter is placed, and the bladder is drained.

Needle Passage

Two suprapubic stab wound incisions, approximately 5 cm lateral to the midline, are made on each side of the lower abdomen at the upper border of the symphysis pubis, and the anterior rectus fascia is exposed. The single-pronged Stamey needle is then inserted into the medial edge of one of the suprapubic wounds such that the tip of the needle scrapes the posterior aspect of the pubic bone. The anterior vaginal wall is identified just lateral to the Foley catheter balloon and simultaneously elevated with the surgeon’s second hand. The needle is then directed, from above, toward the intravaginal fingertip. Once the needle tip is palpable by the intravaginal fingertip, the needle is advanced through the anterior vaginal wall and out through the introitus. The Foley catheter is removed, and cystoscopy is performed to confirm correct positioning of the needle. An appropriately positioned needle, when moved medially, will indent the ipsilateral bladder neck. If the needle penetrates the bladder, it should be removed and repassed.

Suture Transfer

One end of a #2 Proline suture is threaded through the needle, transferred suprapubically, and secured with a hemostat. The Stamey needle is passed a second time, 1 to 2 cm lateral to the first pass, to provide a base of strong fascial support for the suspension. The second pass of the needle should perforate the vaginal tissue approximately 1 cm lateral to the initial pass to avoid tenting up a large amount of vaginal tissue at the completion of the procedure. The position of the Stamey needle is again confirmed with cystoscopy. The free end of the Proline is threaded through a Mayo needle, and two or three helical bites of vaginal tissue are taken between the first and second vaginal perforation. The Mayo needle is then unthreaded, and the free end of the Proline suture is then advanced through the eye of the previously positioned Stamey needle. The needle is withdrawn, and the two ends of the suspension suture are secured with a hemostat for later tying. The periurethral tissue is now suspended on one side of the bladder neck. Needle passage and suture transfer are then repeated on the contralateral side.

Cystoscopy and Closure

Cystoscopy is performed to evaluate the placement of the needle and sutures and to confirm adequate functional closure of the bladder neck with minimal tension placed on the Proline sutures. An antibiotic-impregnated vaginal pack is placed, and the suprapubic Proline sutures are tied, without tension, such that the knots rest against the rectus fascia. A suprapubic catheter is placed, and the suprapubic wounds are closed with a 4-0 polyglycolic acid suture following antibiotic irrigation.

The vaginal packing may be removed 2 hours after surgery, and the patient may be discharged as early as 6 hours postoperatively. The suprapubic catheter is removed no earlier than 1 week after surgery once the postvoid residuals are less than 60 ml.

Outcomes

Complications

An overall complication rate of 9.8% for the Gittes no-incision urethropexy has been reported. Potential complications include prolonged urinary retention (2% to 7%), suprapubic pain or cellulitis, genitofemoral or ilioinguinal nerve entrapment, vaginitis, and suture infection with abscess formation, which could require the removal of a suspension suture (and possibly lead to recurrent stress urinary incontinence).

Results

Reported success rates in the English literature for cure of stress incontinence with the Gittes no-incision urethropexy vary between 81% and 94% depending on the length of follow-up and definition of cure. There are no adequately done studies that have evaluated the long-term efficacy of the Gittes no-incision urethropexy. Kursh evaluated factors influencing the outcome of this procedure and found a significantly decreased cure rate in postmenopausal women and in patients with a greater degree of incontinence preoperatively. As expected, women with type 1 stress incontinence had better outcomes than patients with type 3 stress incontinence (97% versus 45% cure rate, respectively).

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