Transvaginal Enterocele Repair

An enterocele is a hernia of the peritoneal pouch of Douglas extending caudally between the vagina and rectum. It usually contains small bowel with or without omentum. Nichols described four types of enterocele:

  • Congenital enterocele, the least common, occurs when the anterior and posterior peritoneal folds fail to fuse during fetal development.
  • Pulsion enterocele is caused by a chronic increase in intra-abdominal pressure.
  • Traction enterocele occurs when a pelvic organ, for example the uterus, bladder, or rectum, prolapses and causes traction on the vaginal vault and peritoneum.
  • Iatrogenic enterocele occurs after hysterectomy, when excess peritoneum remains or the pouch of Douglas is not adequately closed. It may also occur after any procedure that alters the vaginal axis.

The two types of enterocele that urologists most often encounter are traction enterocele associated with anterior vaginal wall prolapse such as cystocele and iatrogenic enterocele that follows surgery on the anterior vaginal wall. Traction enteroceles often present with a concomitant cystocele and stress incontinence in any patient who has previously had a hysterectomy. It may be part of a total vaginal eversion. Iatrogenic enterocele is not uncommon after surgery for stress incontinence and has been reported in 3% to 17% of cases.

In order to understand the pathophysiology of an enterocele, one must first consider normal pelvic anatomy. The levator plate provides the primary support for the pelvic organs and directly supports the rectum and vagina. The distal vagina forms an approximately 45-degree angle with the vertical line while the proximal vagina forms a 110-degree angle and sits almost horizontally over the levator plate. The distal vagina is supported primarily by perivaginal or pubocervical fascia (which is a portion of the levator fascia) and its attachment to the tendinous arch. This proximal portion of the vagina is also anchored along with the cervix over the levator plate by the cardinal and uterosacral ligarnents, which are attached to the tendinous arch and sacrum, respectively. When there is an alteration in this support, commonly seen after hysterectomy, enterocele may occur.

DIAGNOSIS

An enterocele usually appears as a mass bulging from the vagina. If the uterus is in place, the enterocele will appear posterior to the cervix. However, more commonly it is seen as a bulge from the apex of the vagina after hysterectomy. Larger enteroceles can be seen bulging out of the vagina introitus. A systematic examination of the vagina and pelvis is the first step in the proper diagnosis of an enterocele. The major differential diagnosis is cystocele and high rectocele. An enterocele may exist independently or in combination with these other forms of pelvic prolapse. It is also important to ascertain if the vaginal vault is prolapsed, as this will affect the type of enterocele repair performed.

The extent of prolapse is first evaluated with the patient in the lithotomy position. The posterior blade of a vaginal speculum may be used to retract the posterior vaginal wall to view the anterior vaginal wall. At this time, the presence of urethral hypermobility, stress incontinence, and cystocele may be assessed. The patient should be instructed to cough and strain during these maneuvers. Next, the blade of the vaginal speculum is rotated to retract the anterior vaginal wall. The posterior wall and vaginal vault are inspected. Prolapse of the posterior vaginal wall can be observed readily with the bladder retracted out of the way. If the patient has not undergone a hysterectomy, the uterus can be evaluated for prolapse and movement. In posthysterectomy patients, support of the vaginal vault must be assessed. A rather large enterocele can occur posterior to the well-supported vault, or the entire vagina may be everted.

Although large enteroceles are often obvious, smaller ones associated with rectocele may appear as a high continuation of the rectocele bulge in the posterior vaginal wall. An enterocele may distinguished from a high rectocele by bimanual examination. A finger may be placed in the patient’s rectum, and she is instructed to cough or bear down. The impulse of the enterocele may be felt against the fingertip as it would during the examination an inguinal hemia. With the index finger in the rectum and the thumb in the vagina, an increased thickness in the rectal vaginal septum may be felt as the enterocele is trapped between the two fingers. This maneuver can be repeated in the standing position (with one foot elevated on a stool) if there is any doubt about the diagnosis. Standing the patient provides a true impression of the degree of prolapse experienced during daily activity. When there is difficulty in distinguishing between cystocele and enterocele, a cystogram with anterior–posterior, oblique, and lateral resting and straining views can be done to help delineate the bladder. Sometimes it is difficult to determine the degree of cystocele and enterocele strictly by physical examination, and this may not be sorted out until the time of surgery.

INDICATIONS FOR SURGERY

Generally, the degree of an enterocele and the amount of discomfort it causes are the indications for surgery. Small enteroceles are often asymptomatic and need not be treated. However, there is a tendency for enteroceles to increase in size over time if left untreated. Larger enteroceles that prolapse outside the vaginal introitus are usually quite uncomfortable. Generally, treatment is driven by patient’s symptoms of discomfort, incontinence, obstructive voiding, and constipation. In cases of severe vaginal prolapse, erosion and ulceration of the vaginal wall may occur, causing a great deal of discomfort. When other pelvic surgery is being performed, e.g., stress incontinence surgery, an enterocele of any size should be repaired at the same time, as they are likely to worsen postoperatively.

When surgery is contemplated, it is important to consider all of the anatomic abnormalities including vaginal vault prolapse, cystocele, urethral hypermobility with or without stress incontinence, rectocele, and the presence of a uterus. Also, the patient’s degree of sexual activity will play a role in the type of surgical procedure performed. Age may also influence the type of procedure being performed. Finally, if the patient might undergo a laparotomy for other pathology, this may influence the type of surgery performed, as a transabdoniinal procedure may be elected.

ALTERNATIVE THERAPY

A nonsurgical alternative for treatment of enterocele and pelvic prolapse is the use of a pessary. Pessaries come in a variety of shapes and sizes and are fit on a trial-and-error basis. Some patients with severe pelvic prolapse are unable to hold the pessary. In others, pessaries are found to be uncomfortable or to cause vaginal infections. A pessary can be used as a temporizing measure until surgery can be performed or as a chronic management of enterocele and pelvic prolapse in patients who do not wish surgical intervention. The type of pessary used is based on the degree of enterocele, presence of a uterus, and other coexisting pathology.

Another surgical alternative for enterocele treatment is colpocleisis, in which the entire vaginal canal is closed. This may be elected in the very elderly or in patients who have failed multiple attempts at repair.

SURGICAL TECHNIQUE

Presurgical Preparations

Once the patient has elected to have surgery, preoperative preparation is simple and consists of a modified bowel prep, which can be performed at home. The day before surgery the patient can begin on a clear liquid diet and also should take an oral laxative such as citrate of magnesia. The evening before surgery the patient should take a self-administered enema. As in all vaginal procedures, the patient receives broad-spectrum antibiotic prophylaxis perioperatively. We prefer to use gentamicin and ampicillin, or vancomycin in patients who are penicillin allergic. Doses of antibiotics are given just before the procedure and are continued for 24 hours after the procedure. At this time, the patient is switched to a broad-spectrum oral antibiotic for 10 days.

Surgical Approach

The choice of the specific type of enterocele repair will depend on several factors. We always prefer a transvaginal repair when possible, as this will reduce morbidity and recovery time. In cases in which laparotomy is being performed for another reason, an abdominal approach is preferred. In selecting the type of transvaginal repair, it is important to note the type and extent of the enterocele. If the vaginal vault is prolapsed, this will require a suspension or fixation of the vaginal vault in addition to the repair of the enterocele. This takes into consideration whether vault prolapse exists and also the degree of anterior vaginal wall prolapse or cystocele. If there is no vault prolapse and no cystocele, a simple repair can be performed. In cases in which there is vault prolapse and cystocele, a vaginal vault suspension is chosen. In cases of vault prolapse with no significant cystocele, a sacrospinous ligament fixation is performed. The sacrospinous ligament fixation can also be used in cases of vault prolapse with cystocele; however, we have found the vault suspension technique to be easier and to yield equal or better results in properly selected patients.

Transvaginal Enterocele Repair

All four variations start with the technique of simple enterocele repair, and other procedures may be performed after this if necessary. The patient is placed in the dorsal lithotomy position and prepped, with attention to adequately scrub the inside of the vagina in preparation for surgery. We usually place an iodoform-soaked pediatric laparotomy pad into the rectum so that it can be easily identified by palpation of the posterior vaginal wall. This is especially helpful when a concomitant rectocele repair is to be performed.

The labia are retracted with silk sutures. If a cystocele repair is to be performed, we usually place a suprapubic tube at the beginning of surgery either by the Lowsley tractor technique or percutaneously. A Scott ring retractor (Lone Star Medical Corporation) is very useful in helping to expose the operative field.

The first step is to isolate, repair, and remove the enterocele sac. This is begun by grasping the enterocele with two Allis clamps and bringing it outside of the vaginal introitus. The vaginal wall is then infiltrated with normal saline to facilitate dissection and separation of tissue planes. A longitudinal incision is made in the vaginal wall along the entire length of the enterocele. The vaginal wall is then carefully dissected away from the underlying pubocervical fascia and enterocele sac. In the initial dissection, care must be taken to stay very superficial and develop the proper plane. This is best accomplished by placing the curve of the Metzenbaum scissors against the vaginal wall. A finger can be placed on the outside of the vaginal wall to stabilize the initial dissection. Once the proper plane is entered, it is usually quite easy to dissect the vaginal wall away from the underlying enterocele sac. Care taken here will prevent early entry into the peritoneal cavity. The dissection of the enterocele is continued all the way to the neck of the enterocele sac. After the enterocele has been completely isolated, the sac is opened, and the peritoneal cavity is entered. At this time, one may see small bowel, omentum, or ovary and fallopian tube in cases where previous hysterectomy without oophorectomy has been performed.

The next step is closure of the enterocele defect or pouch of Douglas. Retraction of the peritoneal contents is best performed using a moist pediatric lap pad and a narrow Deaver retractor. This is assisted by placing the patient in Trendelenburg position so that abdominal organs fall slightly cephalad. The enterocele repair begins posteriorly while the abdominal contents are retracted anteriorly using the Deaver. A #1 PGA suture is first placed through the peritoneum and into the prerectal fascia that overlies the rectum. A circumferential closure of the defect is then performed by placing the pursestring suture laterally in the right in the uterosacral–cardinal ligament complex, anteriorly in the peritoneum, overlying the base of the bladder, laterally on the left in the uterosacral–cardinal ligament complex, and finally again posteriorly in the prerectal fascia. After this pursestring suture has been placed, a second one is placed in the identical structures in close proximity to the first. Care should be taken to place these sutures deep enough to ensure that adequate vaginal depth can be achieved. After the second pursestring suture has been placed, a third #1 PGA suture is placed from the right to the left uterosacral–cardinal ligament complex. This suture helps to reinforce the repair and also will be left tagged to help identify this complex later should it be necessary. After all sutures are placed, the assistant cinches down and places tension on one of the pursestrings while the surgeon ties the other. After this has been tied, the second pursestring is tied in a similar manner, followed by the uterosacral–cardinal ligament suture. The two pursestring sutures may now be cut while the third is left tagged. The excess enterocele sac may be excised, and the ends oversewn with a 2-0 PGA suture. If only a simple enterocele repair is performed, the tagged suture may now be cut. Excess vaginal wall is then excised, and the vaginal wall is closed with a running 2-0 PGA suture incorporating deep tissue to obliterate any dead space. An antibiotic-impregnated vaginal packing is placed for a period of 24 hours.

Enterocele Repair with Vault Suspension

The vault suspension procedure may be used when the vaginal vault has prolapsed and a cystocele is present. The size of the cystocele will determine the choice of vault suspension. For moderate cystocele (grades 2 and 3) with primarily lateral defects, the four-corner vault suspension and cystocele repair is the procedure of choice. When severe anterior vaginal wall prolapse is present with a grade 4 cystocele and a large central defect of the bladder through the pubocervical fascia, vault suspension with repair of grade 4 cystocele is used. These procedures incorporate techniques of two previously described repairs for moderate and severe cystocele.

Four-Corner Vault Suspension

After simple enterocele repair has been completed, the vaginal wall is left open, and the anterior vaginal wall is further infiltrated with normal saline. An inverted-U incision with the apex halfway between the bladder neck and the urethral meatus is made. The sides of the U are extended proximally to the level of the vaginal cuff and the uterosacral–cardinal ligament complex where the previous enterocele repair had been performed. The vaginal wall is then dissected laterally off the glistening surface of the periurethral fascia and out to the pubic bone in a manner identical to that performed for the Raz bladder neck suspension. Once the pubic bone is reached, the retropubic space is entered with sharp dissection, detaching the urethropelvic ligament from the tendinous arch using a curved Mayo scissors. A finger can then be placed in the retropubic space, and any adhesions bluntly lysed. Two #1 polypropylene suspension sutures are placed on each side. The distal sutures are identical to those for a Raz needle bladder neck suspension. They include two or three helical bites of full-thickness vaginal wall without its epithelium, pubocervical fascia, and urethropelvic ligament at the level of the bladder neck. The proximal sutures incorporate two to three helical bites of full-thickness vaginal wall without epithelium at the level of the vaginal cuff, pubocervical fascia, and the uterosacral–cardinal ligament complex. This complex can be identified by placing tension on the previously placed #1 PGA suture, which had been left tagged. After these sutures are placed, tension should be placed on them individually to make sure they are in strong tissue. The patient should be able to be moved on the table by pulling on each suture. The procedure is then repeated on the opposite side. Once these sutures have been placed, a stab incision is made in the anterior abdominal wall at the superior border of the symphasis pubis in the midline. A Pereyra–Raz double-pronged ligature carrier (Cook Urological) is placed in this incision and brought through the retropubic space under direct finger guidance. Each of the four suspension sutures is transferred to the anterior abdominal wall individually, as in other needle suspension procedures. Once these sutures have been transferred, gentle tension is placed to make certain that there is reduction of the cystocele.

Cystoscopy is performed to document that there has been no injury to the bladder and that the bladder neck and proximal urethra elevate and coapt nicely. Ureteral injury is ruled out by having the anesthesiologist give intravenous indigo carmine and observing for efflux of blue from each of the ureteral orifices.

The vaginal wall is closed with a running interlocking 2-0 PGA suture. After closure of the vaginal wall, the previously placed suspension sutures are tied with minimal tension. Antibiotic-soaked vaginal packing is placed, and the small suprapubic incision is closed with a subcuticular 4-0 PGA suture.

Vault Suspension with Grade 4 Cystocele Repair

A vertical midline incision is made in the entire anterior vaginal wall after it has been infiltrated with normal saline. This incision will extend from the midurethra all the way through the vaginal cuff and sometimes into the posterior vaginal wall. As described above, the vaginal wall is then dissected from the underlying cystocele, enterocele, and pubocervical fascia. In these cases, it is usually the bladder that is first encountered. The large cystocele is dissected out almost in its entirety. Once most of the posterior portion of the cystocele has been dissected, the enterocele sac is usually seen. After the enterocele sac is identified, its posterior margin can be dissected off of the vaginal wall. It is extremely important to completely separate the anterior margin of the enterocele sac from the bladder. If this plane is not obvious on initial dissection, it can be seen more easily after the enterocele has been opened. Adhesions of the enterocele sac to the bladder can safely be dissected with a finger inside the enterocele sac. Once the cystocele and enterocele have been completely separated, the retropubic space is entered by perforating the endopelvic fascia as described above for the four-corner vault suspension.

The bladder may be reduced and packed up in its normal position with a gauze sponge so that enterocele repair can be performed first. The enterocele sac is opened, and the peritoneal cavity entered. Once the enterocele sac has been mobilized all the way to its neck and the cystocele is adequately reduced, enterocele repair can be performed (as described above for simple enterocele repair). After completion of the enterocele repair, attention is turned to the cystocele. Anterior vaginal wall and vault suspension sutures of #1 polypropylene are placed. The distal sutures include the urethropelvic ligament, pubocervical fascia, and full thickness of vaginal wall without the epithelium at the level of the bladder neck. The proximal sutures are placed in the pubocervical fascia, uterosacral–cardinal ligament complex (again identified by the previously placed tagged suture), and the full thickness of the vaginal wall without the epithelium. These sutures are transferred to the anterior abdominal wall through a stab incision in the identical manner described for the four-corner vault suspension. Next, the central defect of the cystocele is closed, approximating the attenuated pubocervical fascia in the midline, using a 2-0 PGA suture. During the repair of the central defect, the bladder is kept reduced with either a gauze sponge, which is removed, or PGA mesh, which can be left in place. After completion of the cystocele repair, cystoscopy is performed as above. The excess anterior vaginal wall is closed with a running interlocking 2-0 PGA suture incorporating deep tissue to avoid any dead space. If present, the rectocele is repaired at this time. After closure of the vaginal wall, the suspension sutures are tied with minimal tension. Antibiotic-soaked vaginal packing is placed, and the suprapubic incision is closed with a 4-0 subcuticular PGA suture.

Sacrospinous Ligament Fixation

This technique is used to repair enterocele and vault prolapse in cases in which the anterior vaginal wall is well supported. This commonly occurs after bladder neck suspension or colposuspension. Certainly, one would not want to jeopardize the previous anterior vaginal wall repair by performing a vault suspension. In this case, vaginal depth and axis are restored by posterior fixation of the vaginal vault to the sacrospinous ligaments. The sacrospinous ligament stretches from the ischial spine to the sacrum and is covered by the coccygeus muscle. This procedure may also be used with cystocele repair, but we prefer the vault suspension in this instance.

After simple enterocele repair is completed, the posterior vaginal wall must be opened far enough distally to facilitate dissection to the sacrospinous ligament. When a simultaneous rectocele repair is to be performed, the entire posterior vaginal wall is opened through the perineum. After the posterior vaginal wall is incised in the midline, it is gently dissected laterally from the underlying prerectal fascia for a short distance. Next, the sacrospinous ligament must be identified. This is done by penetrating the right or left rectal pillar (pararectal fascia) sharply and entering the pararectal space. Blunt dissection of the pararectal space can be performed with a combination of finger dissection and the use of deep Breisky–Navratil retractors. This dissection is performed until the sacrospinous ligament is palpated and overlying coccygeus muscle is seen. The Breisky–Navratil refractors will help to expose the ligament. Once the ligament is identified, a #1 PGA suture is placed through the ligament and coccygeus muscle complex 2 cm medial to the ischial spine, which is also identified by palpation. It is important to place the suture in this position to avoid injury to the pudendal nerve and vessels, which run just below the ischial spine. It is also important to include the strong ligament in addition to the overlying coccygeus muscle. Tension should be placed on this suture to make certain that it is in the ligament. A second suture should be placed adjacent to the first. Each of these sutures is then placed through the full thickness of the vaginal wall at the level of the dome, approximately 1 cm apart, and left untied. If a rectocele is present, it is repaired at this time. The dome of the vagina can be directed under finger guidance to the deepest possible portion, where it will be fixed. The vaginal wall is then closed with a running interlocking 2-0 PGA suture, and then the previously placed sacrospinous ligament fixation sutures are individually tied. Antibiotic-impregnated vaginal packing is then placed.

An intra-abdominal approach to enterocele may also be performed. We usually reserve this for when laparotomy is being performed for other reasons. The abdominal approach described by Moschcowitz is similar to the simple enterocele repair that we use except that the approach is from above.1 In cases of vault prolapse, a colposacropexy can be performed using autologous rectus fascia or a synthetic mesh.

After completion of the surgical procedure, the antibiotic-soaked vaginal packing is left in the vagina until the next morning. Patients receive two to three postoperative doses of intravenous antibiotics before they are switched to broad-spectrum oral antibiotic. In the case of simple enterocele repair or sacrospinous fixation, when no suprapubic tube is used, the oral antibiotic is continued for 7 to 10 days. In cases where a suprapubic tube is left indwelling, antibiotics are usually continued until normal voiding resumes and all tubes are removed. Patients are usually hospitalized for 24 to 48 hours. They may resume light activity on discharge and only restrain from heavy lifting, strenuous exercise, and intercourse for 6 weeks.

OUTCOMES

Complications

When the algorithm described above was used for 83 patients, 14% experienced complications.5 Operative complications included one bladder and one ureteral injury. Most of the delayed complications were minor and included suprapubic wound infection (2.5%), cystocele (1.2%), rectocele (1.2%), flap of excess vaginal tissue requiring excision (1.2%), and chronic suprapubic pain (1.2%). In one patient in whom hysterectomy was not performed with enterocele, uterine prolapse developed, and vaginal hysterectomy was done. Other possible complications that did not occur in our series include small bowel or rectal injury, vaginal shortening limiting the ability to have intercourse, prolonged urinary retention, de novo stress or urge incontinence, and pelvic pain from pudendal nerve entrapment following sacrospinous ligament fixation.

Results

We used the above algorithm on 83 consecutive patients undergoing enterocele repair. Forty-nine (60%) underwent simple repair, 25 (31%) had vault suspension with enterocele repair (eight had four-corner and 17 had grade 4 cystocele repair), and seven (9%) had sacrospinous ligament fixation. Overall success (no recurrence) was 86%: 82% for simple repair, 96% for vault suspension, and 86% for sacrospinous ligament fixation. A total of 11 patients suffered recurrence at a mean of 11 months (range 4 to 32 months). Two of these occurred after further vaginal surgery, and one after pelvic trauma. Success for sacrospinous ligament fixation has previously been reported to be 62% to 97%.

Cystocele

A cystocele represents herniation of the urinary bladder through the weakened supportive fascia of the anterior vaginal compartment. Cystoceles range from involvement of only a small portion of the bladder base with a well-supported urethra to involving virtually the entire bladder and urethra. Cystocele is one of the manifestations of pelvic floor relaxation and prolapse. Within the context of pelvic floor relaxation, cystocele is commonly associated with other defects in the support of the superior and posterior compartments of the vagina as well. Loss of superior support (uterine prolapse, vault prolapse, and enterocele) and loss of posterior support (rectocele and perineal laxity) may coexist with defects of anterior compartment prolapse (cystocele and urethral hypermobility) and will require a coordinated approach and simultaneous repair.

Anatomically, a cystocele is the result of loss of pelvic floor support because of weakness of the levator fascia. The levator fascia has the principal role in the support of the anterior vaginal wall, urethra, and bladder. This fascial sheet covering the levator musculature of the pelvic floor inserts on the tendinous arch of the obturator muscle laterally and has a vaginal side and an abdominal side. The abdominal side is referred to as the endopelvic fascia. The vaginal side is called the periurethral fascia at the level of the urethra and the perivesical fascia at the level of the bladder. Together, the periurethral and perivesical fascia comprise the pubocervical fascia. The abdominal and vaginal sides fuse laterally as they insert onto the tendinous arch of the obturator. This fascia has several important condensations that provide lateral support to the bladder and urethra. The pubourethral ligaments support the midurethra to the inferior margin of the pubic bone. The urethropelvic ligaments suspend the urethra to the lateral pelvic sidewall from the bladder neck to the external meatus. The vesicopelvic ligament extends laterally to the pelvic sidewall, supporting the bladder, and finally, the cardinal ligaments extend from the cervix and upper vagina supporting these structures to the pelvic sidewall.

Anterior compartment weakness may involve the supporting structures of the urethra, the bladder, or both. Isolated defects in support of the urethra alone result in urethral hypermobility without cystocele. This may result in stress urinary incontinence and is discussed elsewhere in this text. Defects in the anatomic support of the bladder with or without coexisting involvement of the urethra result in cystocele. The cystocele defect may involve either the central or lateral support of the bladder and urethra, or it may be a result of weakening of both. Isolated central cystoceles are found when the fascia spanning the levator hiatus on the vaginal side (perivesical fascia) becomes attenuated without compromise of the lateral support (urethropelvic and vesicopelvic ligaments). Separation or attenuation of the cardinal ligaments in the midline usually contributes to the anatomic defect in central cystoceles, and reapproximation of these structures is critical to effect repair and prevent the onset of enterocele postoperatively. Isolated central cystoceles are a rare condition and comprise fewer than 10% of cystoceles. Isolated lateral cystoceles are more common and result from weakness or disruption of the lateral attachments of the vesicopelvic or anterior cardinal ligaments to the pelvic sidewall without significant weakness of the central support. Urethral hypermobility is commonly associated with lateral fascial defects. Combinations of central and lateral fascial defects are the most common presentation of cystocele and may result in severe degrees of prolapse.

DIAGNOSIS

Patients with cystoceles may be asymptomatic, may have associated stress urinary incontinence, or may complain of an introital bulge or a sensation of a mass in the vagina. Large cystoceles may cause kinking of the bladder neck and urethra, resulting in obstructive urinary symptoms, incomplete emptying, and, less commonly, frank urinary retention. Severe cystoceles may result in obstructive hydronephrosis and renal failure from urethral and ureteral obstruction. Rarely a cystocele may present as dyspareunia or incontinence during sexual intercourse. On physical examination, cystoceles appear as a midline mass in the vagina anterior to the cervix or vaginal cuff (if a hysterectomy has been performed). If significant pelvic relaxation is present, a cystocele may be present outside the vaginal introitus at rest or may bulge outside the introitus with Valsalva maneuver. It is important to differentiate cystocele from the other manifestations of pelvic prolapse that also may present with masses protruding from the vagina, including enterocele and rectocele. Examination with a half speculum will locate the vaginal cuff. Significant enteroceles and rectoceles will usually present posterior to the vaginal cuff or cervix. If there is doubt, cystography can be of assistance.

Lateral fascial defects causing cystoceles are identified in those patients with significant urethral and anterior vaginal wall hypermobility on stress maneuvers during physical examination. On examination with a half speculum directed posteriorly reducing any coexisting enterocele or rectocele, these patients have hypermobility of the entire anterior vaginal wall on stress with laxity of support for the anterolateral vaginal wall.

Isolated central fascial defects are rare and result from attenuation of the perivesical fascia in the midline and separation of the cardinal ligaments without evidence of lateral fascial weakness. Clinically these patients have a distinct anterior midline vaginal bulge without coexisting loss of support for the urethra and anterolateral vaginal wall. Typically there is no urethral hypermobility, as the lateral support of the urethra is unaffected.

Combined lateral and central defects are common and can result in urinary obstruction with or without incontinence when severe.

It is important to ascertain the level of sphincteric competence preoperatively in any patient undergoing cystocele repair. Clearly, if the patient is incontinent, some type of procedure to increase outlet resistance is needed in addition to cystocele repair. However, many patients presenting with cystoceles may not have associated symptoms of stress incontinence. In these patients sphincteric incompetence may be masked by the valvular effect of the cystocele. If the cystocele is repaired in isolation, the protective valvular effect of the cystocele on the urethra and outlet will be lost. In this case, despite adequate repair of the cystocele, the unsuspended urethra will remain in a low-lying unprotected position, and the patient will have a substantial risk of postoperative incontinence. Therefore, any degree of urethral hypermobility in the presence of a cystocele, with or without urinary incontinence preoperatively, should be repaired at the time of surgery by simultaneous suspension or sling.

Finally, a cystocele with a well-supported, nonmobile urethra from a previous suspension in combination with poor emptying ability may signal urethral obstruction. This may be caused by urethral obstruction (from the previous suspension or the cystocele or both) or detrusor hypocontractility. Patients with urethral obstruction from previous surgery may require urethrolysis and resuspension in addition to cystocele repair in order to avoid postoperative urinary retention. Patients with poor detrusor contractility should be alerted to the high risk of long-term intermittent catheterization postoperatively. Careful preoperative urodynamics with the cystocele reduced will help sort out these situations.

INDICATIONS FOR SURGERY

The repair of cystocele is based on several factors: the presence or absence of urinary incontinence, the grade of the cystocele, the inherent pathophysiological fascial weakness (central or lateral), emptying ability, and the associated vaginal or abdominal pathology to be repaired (uterine prolapse, enterocele, rectocele, etc.). Asymptomatic, small cystoceles with no evidence of stress urinary incontinence (SUI), urinary obstruction, and absence of other manifestations of pelvic prolapse do not require surgical repair. Small grade I and II cystoceles resulting from lateral fascial defects associated with SUI are usually adequately repaired using the Raz vaginal wall sling described in this text and elsewhere.

Cystoceles resulting from an isolated central fascial defect without concomitant SUI, urethral hypermobility, or demonstrated sphincteric incompetence with the cystocele reduced can undergo a central fascial defect repair alone. It should be noted that this is an uncommon presentation, and this procedure is rarely performed in isolation at our center.

In patients with a moderate cystocele resulting from a lateral fascial defect, we utilize a six-corner bladder suspension. This group of patients has, by definition, associated urethral hypermobility as a result of the associated anatomic fascial defect. The urethral hypermobility as well as the cystocele will be corrected by the six-corner suspension. This operation is a modification of our previously described four-corner suspension.3 This evolution came about from our improved understanding of the importance of the midurethral complex in the maintenance of continence in many women.

In patients with a severe cystocele (grade IV) and both a lateral and central fascial defect, a combined lateral and central fascial defect repair with mesh and vaginal wall sling will be performed. This is also a modification of a previously described procedure now redesigned to incorporate the midurethral complex into the repair.

ALTERNATIVE THERAPY

With rigorous physical therapy and intensive pelvic floor rehabilitation, some small cystoceles can be eliminated by strengthening the pelvic floor musculature. The addition of oral or topical estrogens may augment the response to nonsurgical therapy in those patients who are poorly estrogenized. Larger cystoceles without significant urinary obstruction but large enough to be bothersome to the patient can be reduced and treated with a pessary. This is also effective in those patients whose coexisting medical illness precludes surgery.

Commonly used surgical alternatives to the transvaginal procedures described below include various transabdominal procedures including the Richardson para-vaginal repair, the Burch colposuspension, and the Marshall–Marchetti–Krantz (MMK) repair. Transabdominal retropubic procedures such as the paravaginal repair and the colposuspension are indicated when the presence of other intra-abdominal pathology (large uterine leiomyomas requiring abdominal hysterectomy, ovarian pathology, etc.) requires concomitant surgical exploration. It should be noted that these procedures do not address central fascial defects and are useful only for repairing isolated lateral fascial defects. The use of retropubic procedures to repair cystoceles resulting from central defects may actually aggravate the condition, as the lateral tension placed on the suspending sutures may create increased midline fascial separation through additional shearing forces on the already weakened central fascia. The MMK should never be utilized for the repair of cystocele, as the sutures are placed too medially over the urethra to have a significant impact on the intrinsic fascial defect causing the cystocele. Simultaneous abdominal and vaginal approaches may be necessary in some cases with combined pathology.

Transvaginal approach to cystocele repair has several distinct advantages over the abdominal approach. Vaginal incision is associated with less postoperative pain and discomfort and a faster return to regular activities. Coexisting vaginal pathology such as rectocele, enterocele, and vault prolapse are easily repaired through the same or a slightly extended incision. Finally, both the lateral and central fascial defects resulting in the appearance of the cystocele are completely isolated and repaired under direct vision with a vaginal approach.

SURGICAL TECHNIQUE

Combined Repair of Lateral and Central Defects with Mesh and Vaginal Wall Sling

This procedure will repair the lateral and central fascial defects as well as the associated urethral hyper-mobility. The lateral fascial defect is repaired by non-absorbable sutures placed through the ligamentous supports of the bladder and urethra and then suspended to the anterior rectus fascia. The vaginal wall sling is accomplished by these same suspension sutures, thus repairing the urethral hypermobility. Finally, the central defect is repaired by reapproximating the cardinal ligaments in the midline and then placing several interrupted sutures plicating the perivesical fascia from the bladder neck to the level of the cardinal ligaments.

Preparation

Most vaginal surgery at our institution is performed on an outpatient basis. Antibiotics are administered parenterally 1 hour before incision. General anesthesia is preferentially used in all our vaginal surgery unless medically contraindicated.

The patient is brought to the operating room and placed in the dorsal lithotomy position with candy-cane stirrups. The buttocks are placed just off the end of the operating room table. All pressure points are padded, and care is taken to ensure that no lower extremity joint is flexed more than 90 degrees. The lower abdomen and perineum are shaved. A povidone/iodine vaginal scrub and painting are performed. The anus is draped out of the field with a self-adherent clear plastic drape. The remaining drapes are secured with silk suture across the perineum to ensure separation of the fecal and urinary streams. A weighted vaginal speculum is placed, and labial retraction sutures of 3-0 silk are used for maximal exposure.

A Lowsley retractor is placed per urethra and supported at the meatus. The tip of the Lowsley is directed anteriorly, and a suprapubic incision is performed approximately two fingerbreadths cephalad to the superior margin of the symphysis pubis in the midline. The incision is carried sharply down onto the tip of the Lowsley, and the Lowsley is extruded through the anterior abdominal wall. A 16-Fr Foley catheter is grasped and brought into the bladder and confirmed in good position by irrigation with a Toomey syringe. An additional 16-Fr Foley is placed per urethra. If indicated, a vaginal hysterectomy is now performed.

Goalpost Incision

A ring retractor is placed, and the hooks are used to expose the introitus. The anterior vaginal wall overlying the cystocele is grasped and everted through the introitus. Infiltration with injectable saline is performed along the anterior vaginal wall in the line of a goalpost-shaped incision. The limbs of the goalpost are slightly obliqued and are located on the anterior vaginal wall 1 cm from the reflection of the lateral walls of the vagina. The obliqued limbs of the goalpost extend from the midurethra to just beyond the bladder neck. The proximal extent of the paired oblique incisions are connected across the midline under the bladder neck, and then a single incision is carried to the level of the vaginal apex in the midline. The preserved island of tissue beneath the proximal urethra and bladder neck will be used for the placement of the sling sutures.

Development of the Vesicovaginal Space

The cut edges of the vaginal wall in the midline are grasped with Allis clamps to provide countertraction for the ensuing initial dissection. Sharp, shallow dissection is then carried out laterally, using Metzenbaum scissors, to develop the vesicovaginal space. This plane is avascular, and the vaginal wall should easily separate from the underlying periurethral and perivesical fascia. In reoperative cases, the vesicovaginal space may be difficult to define, and very shallow sharp dissection on the vaginal wall is imperative to avoid inadvertent entry into the bladder.

Lateral and anterior dissection toward the limbs of the goalpost incision is carried out first. Posterior dissection toward the vaginal cuff in patients who have had previous hysterectomy can be difficult, and extreme care should be taken to avoid inadvertent bladder injury. Initial mobilization of the anterior and lateral vaginal walls will make the difficult posterior dissection toward the vaginal cuff considerably less dangerous because the tissues can be reflected over the surgeon’s finger in order to facilitate dissection in the correct plane. Careful attention should be paid to the possible presence of a coexisting enterocele in the region of the vaginal cuff.

All dissection should be done under direct vision. The hooks of the ring retractor can be replaced onto the developing vaginal flaps to assist in exposure. Excessive bleeding during the early portion of the dissection indicates entry into an incorrect plane and may signal imminent bladder perforation. Sudden brisk bleeding in the posterior dissection toward the vaginal cuff may indicate severing of a branch of the uterine artery. This can be readily controlled under direct vision with forceps and cautery. However, cautery should be kept to a minimum to avoid tissue devitalization and subsequent development of vesicovaginal fistula.

The entire bladder base with attached fascia should be dissected free of the vaginal wall. Anteriorly, the periurethral fascia should be exposed toward the inferior pubic ramus and its attachment to the tendinous arc of the obturator muscle. Posteriorly, the dissection is carried to the level of the vaginal apex in the region of the cardinal ligaments.

Once the entire cystocele has been dissected from the anterior vaginal wall, a 2-0 synthetic absorbable suture (SAS) is placed through the area of the cardinal ligaments so that it will reapproximate both cardinal ligaments to the midline when tied. This stitch is not tied at this time, as it marks the proximal extent of the central defect repair.

Repair of the Lateral Fascial Defect

Attention is now turned to the suspension. The retropubic space is entered with Mayo scissors pointed at the ipsilateral shoulder, perforating the urethropelvic ligament at its insertion onto the tendinous arc of the obturator muscle. The urethropelvic ligament is released from its attachment to the tendinous arc. The adhesions in the retropubic space are lysed bilaterally, leaving the urethra freely mobile.

The four suspending sutures (two proximal and two distal sutures) of #1 polypropylene (Prolene) are now placed. The proximal suture individually incorporates three structures: the proximal edge of the released urethropelvic ligament at the bladder neck, the perivesical fascia at the reflection of the dissected vaginal wall midway between the bladder neck and the cardinal ligaments, and, finally, the area of the cardinal ligaments at the level of the vaginal cuff. Exposure of the proximal portion of the urethropelvic ligament is aided by placing blunt forceps into the retropubic space and retracting the urethra medially. The suture is then passed through all these structures again.

The distal polypropylene suture is passed with helical bites through the midurethral complex, urethropelvic ligament, and the periurethral fascia (anterior vaginal wall excluding epithelium). Exposure of the midurethral complex is facilitated by opening a forceps horizontally within the retropubic space and placing downward traction with the open forceps. This suture incorporates the midurethral complex, including the pubourethral ligament and levator entrance into the urethra, and the distal aspect of the freed urethropelvic ligament and finally is passed parallel to the anterior vaginal wall to include the periurethral fascia but exclude the vaginal epithelium. The identical two sutures are placed on the opposite side.

Transfer of Sutures

A 1-cm skin incision is performed at the upper margin of the symphysis pubis on the lower abdominal wall. Blunt dissection is carried down to the anterior abdominal wall fascia. A double-pronged ligature carrier is now passed from the suprapubic incision to the vaginal incision under fingertip guidance. The ligature carrier should scrape the posterior surface of the symphysis as it is passed to avoid inadvertent bladder or urethral injury. Piercing the abdominal wall fascia too cephalad off the superior margin of the pubis will result in mobility of the sutures and considerable postoperative pain and discomfort.

The ligature carrier is used to transfer the four sutures individually from the vagina to the abdominal incision. They are not tied at this time. These four sutures represent the repair of the lateral defect of the cystocele as well as the vaginal wall sling.

Repair of the Central Fascial Defect

Absorbable mesh (Dexon or Vicryl) is used to pack and reduce the cystocele cephalad in the midline. This is left in situ but is not sutured in place. Interrupted horizontal mattress sutures of 2-0 SAS are placed in the lateral edges of the perivesical fascia sequentially from the bladder neck to the area of the cardinal ligaments. These imbricating sutures are placed just medially to the suspending polypropylene sutures into the perivesical fascia but are not tied. Usually four or five sutures are required to close the defect.

Cystoscopy

The urethral Foley is removed, and cystoscopy is performed to ensure that a polypropylene suture has not been inadvertently placed through the bladder or urethra as well as to confirm efflux from both ureteric orifices. The suprapubic tube location should be confirmed as well. Gentle upward traction on the suspending sutures should elevate the bladder neck and proximal urethra as viewed through the cystoscope.

Up to this point the operation is completely reversible, as no sutures have been tied. Thus, if a misplaced suture or incidental cystotomy is detected on cystoscopy, it is easily remedied.

Closure of the Vaginal Wall

The cardinal ligament suture is now tied, thus reapproximating these structures toward the midline at the level of the vaginal apex or cuff. The sutures repairing the central defect are now tied.

The limbs of the goalpost incision are closed with a running interlocking 2-0 SAS. The excess vaginal wall is trimmed, and the remaining vaginal wall is closed with 2-0 SAS in a running interlocking fashion incorporating the underlying central defect repair, thus closing potential dead space. The vagina is packed with an antibiotic-impregnated gauze.

Completing the Suspension

The suprapubic sutures are tied with the knot laid down onto the anterior abdominal wall fascia under no tension. A cystoscope sheath should be placed per urethra at a 30-degree incline while the suspending sutures are tied down. In our experience, if the cystoscope sheath maintains elastic mobility after all the sutures are tied, then there is no undue tension on the suspending sutures. The suprapubic incision is irrigated with antibacterial solution and closed with a subcuticular 4-0 SAS.

Postoperative Care

The SP tube is placed on slight traction and left to gravity drainage. The vaginal pack is removed in 2 to 3 hours. The patient is allowed to void immediately postoperatively. Postvoid residuals are checked every 2 to 3 hours. The patient is discharged from the same-day surgery unit when ambulatory and able to tolerate a regular diet. She is taught suprapubic tube care and how to measure her own postvoid residuals. When the residual is less than 30 to 60 cc, the suprapubic tube is removed. Alternatively, when the postvoid residuals remain high, the patient is taught clean intermittent catheterization techniques, and the tube is removed at the end of 4 weeks.

The patient may resume all regular activities immediately postoperatively except heavy lifting, running, and sexual intercourse. These limitations are removed at 4 weeks at the time of the first postoperative office visit.

Repair of Lateral Defect (Six-Corner Bladder Suspension)

This procedure is best suited for those patients with moderate cystoceles (grade II or III) and primarily lateral fascial defects.

Preparation

The positioning, preparation, and placement of suprapubic tube are identical to those for the repair described above.

Incision

The anterior vaginal wall overlying the distal urethra is grasped with an Allis clamp and stretched cephalad. Two oblique vaginal incisions are performed 1 cm medial to the reflection of the lateral vaginal wall onto the anterior vaginal wall, from the midurethra to the region of the vaginal cuff (if a hysterectomy has been performed) or to the paracervical region if the uterus is to be preserved.

Exposure of Ligamentous Supports

Sharp dissection is carried laterally from both incisions using the Metzenbaum scissors. Proximally, dissection is performed to expose the area of the cardinal ligaments. Distally, lateral dissection is carried over the glistening periurethral fascia, exposing the insertion of the urethropelvic ligament onto the tendinous arch of the obturator muscle.

The retropubic space is entered with Mayo scissors pointed at the ipsilateral shoulder and perforating the urethropelvic ligament at its insertion onto the tendinous arc of the obturator muscle. The urethropelvic ligament is released from its attachment to the tendinous arch bluntly. The adhesions in the retropubic space are lysed bilaterally, leaving the urethra freely mobile.

Placement of Sutures to Repair the Lateral Fascial Defect

Three sutures of #1 polypropylene (Proline) are placed on each side. Each suture incorporates multiple passes through the tissue. The proximal suture is passed through the perivesical fascia parallel to the anterior vaginal wall, incorporating the area of the cardinal ligaments at the apex of the vagina but excluding the vaginal epithelium. If passed correctly, this suture should be anchored into very strong, supportive tissue.

The middle suture is first placed at the level of the bladder neck and is passed with helical bites through the perivesical fascia parallel to the anterior vaginal wall excluding the vaginal epithelium. The bladder neck is then held medially and the suture is placed through the freed proximal edge of the urethropelvic ligament in a helical fashion at the level of the bladder neck.

The third suture is placed at the level of the midurethral complex. Exposure of the midurethral complex is facilitated by opening a forceps horizontally within the retropubic space and placing downward traction with the open forceps. This suture incorporates the midurethral complex, including the pubourethral ligament and levator entrance into the urethra, and the distal aspect of the freed urethropelvic ligament and finally is passed parallel to the anterior vaginal wall including the periurethral fascia but excluding the vaginal epithelium.

Transfer of Sutures

A 1-cm skin incision is performed at the upper margin of the symphysis pubis on the lower abdominal wall. The ligature carrier is used to transfer the six sutures individually from the vagina to the abdominal incision in the same manner as described for the combined repair. They are not tied at this time.

Cystoscopy

The urethral Foley catheter is removed, and cystoscopy is carried out examining for intravesical or intraurethral suture as well as proper location of the suprapubic tube at the dome. Urinary efflux should be confirmed from both ureteral orifices.

Closure of the Vaginal Wall

The oblique incisions in the anterior vaginal wall are now closed with a running interlocking 2-0 SAS with care taken not to trap the polypropylene suspension sutures in the closure.

Completing the Suspension

The suprapubic sutures are tied under no tension as described previously, and the abdominal incision is irrigated and closed.

Postoperative Care

The vaginal packing is removed in 2 to 3 hours, and the patient is discharged home when ambulatory and able to tolerate a regular diet. The remaining postoperative care is identical to that previously described for the combined repair.

Repair of a Central Defect

This procedure is specifically indicated only for the repair of isolated central fascial defects with a well-supported, competent, nonobstructed sphincteric mechanism. This is an uncommonly performed procedure, as most central defects are accompanied by other manifestations of pelvic prolapse.

Preparation

The positioning, preparation, and placement of a suprapubic tube are identical to those for the repairs described above.

Incision and Dissection of the Anterior Vaginal Wall

The anterior vaginal wall is infiltrated with injectable saline in the midline from the bladder neck to the apex of the vagina. The anterior vaginal wall overlying the cystocele is then incised sharply with the knife. The cut edges of the vaginal wall are grasped with Allis clamps to provide countertraction for the ensuing initial dissection. Sharp dissection is then carried out laterally, using Metzenbaum scissors to expose the vesicovaginal space and the perivesical fascia. This plane is avascular, and the vaginal wall should easily separate from the underlying periurethral and perivesical fascia. Lateral flaps of vaginal wall are developed from the midurethra to the vaginal apex. A ring retractor can be placed to assist in the retraction of the developing flaps.

Lateral dissection is carried out until the weakened perivesical fascia found in the midline—the cause of the anatomic defect allowing for the formation of the cystocele—is no longer attenuated. This strong lateral aspect of the perivesical fascia will constitute the tissue for the subsequent central defect repair.

Proximal dissection toward the vaginal cuff in patients who have had previous hysterectomy can be difficult, and extreme care should be taken to avoid inadvertent bladder injury. Dissection should be carried proximally to the area of the cardinal ligaments.

Repair of the Central Defect

Repair commences with the reapproximation of the area of the cardinal ligaments in the midline with a 2-0 synthetic absorbable suture. Attention is now turned to the perivesical fascia lateral to the bladder neck on either side. A horizontal mattress stitch of 2-0 synthetic absorbable suture is used to plicate this fascia toward the midline. When tied, this stitch will draw the perivesical fascia beneath the bladder neck. The cystocele is reduced manually or, as we prefer, using absorbable Vicryl or Dexon (polyglycolic acid) mesh. The cystocele is thus packed cephalad, and the mesh is left in situ. The remaining perivesical fascia is then plicated from the level of the bladder neck to the cardinal ligaments with interrupted closely approximated horizontal mattress sutures of 2-0 synthetic absorbable suture. The sutures are not tied at this time.

Cystoscopy

The urethral Foley is removed and cystoscopy is performed to ensure that a suture has not been inadvertently placed through bladder or urethra as well as ensure efflux from both ureteric orifices.

Closure

The plicating sutures are now tied. The excess vaginal wall is trimmed, and the vaginal wall is reapproximated with a running 2-0 absorbable suture. An antibiotic impregnated vaginal packing is placed. In 4 to 6 hours the vaginal packing and Foley are removed.

OUTCOMES

Complications

Complications associated with cystocele repair can be avoided by careful attention to detail during dissection of the cystocele and passage of the ligature carrier. Incidental cystotomy occurs rarely and should be repaired intraoperatively. A multiple-layer closure with nonopposing suture lines and maximal urinary drainage should be performed to prevent late-onset vesicovaginal fistula.

Careful cystoscopic evaluation intraoperatively should alert the surgeon to many other potential complications. Ureteral obstruction is diagnosed by noting the lack of urinary efflux from the ureteral orifice. Removal and replacement of the offending stitch should suffice for repair. Internal ureteral stenting is considered only if there was extensive trauma to the ureter. Inadvertent intravesical or intraurethral placement of nonabsorbable suture will result in recurrent infections and stone formation. This should be recognized intraoperatively during careful cystoscope examination. Removal and replacement of the suture is easily performed if it has not yet been tied as described above.

Postoperative bladder instability is a well-documented complication of cystocele repair. Detrusor instability may result from three sources: continuation of preoperative instability, de novo bladder instability temporally related to cystocele repair, and finally, urethral obstruction as a result of tying the suspension sutures under tension. Preoperative detrusor instability is expected to resolve in over 70% of patients postoperatively. The remaining patients may be treated pharmacologically with anticholinergic agents. De novo instability is treated pharmacologically as well. Nonresolution of de novo instability in the presence of incomplete emptying may indicate urethral obstruction. Tying the sutures with a cystoscope sheath in the urethra under no tension as described is the best way to avoid this complication. Urethral obstruction may require formal urethrolysis or complete takedown of the suspension for resolution. In this situation, resolution of instability can be expected in over 90% of cases.8

Incomplete emptying and urinary retention may also result from poor detrusor contractility unrecognized preoperatively. Long-term clean intermittent catheterization is preferable to indwelling Foley catheterization in these unfortunate cases.

Persistent pain, infection, bleeding, recurrent incontinence, vaginal stenosis and/or shortening, vesicovaginal fistula, ureterovaginal fistula, and dyspareunia are also potential complications of cystocele repair.

Finally, enterocele may result months to years later from alteration of the pelvic axis and insufficient anatomic reapproximation of the cardinal ligaments to the midline during repair. Plication of the perivesical fascia without reapproximation of the cardinal ligaments during repair of central defects leaves a considerable anatomic defect in the region of the vaginal cuff, allowing for the formation of an enterocele.

Results

Because these procedures represent relatively new modifications of previous technique, we are still compiling data on the results. Previously we had reported on the four-corner bladder suspension for moderate cystocele, which is the forerunner of the six-corner bladder suspension described above. This procedure did not incorporate the midurethral complex in the form of the vaginal wall sling as it does now. Nonetheless, with the previous technique, 105 of 107 patients with moderate cystocele were successfully treated at a mean follow-up of 2 years.

We have also reported on a previous modification of the combined repair of central and lateral defects. Likewise, this procedure did not incorporate the midurethral complex in the repair. In this preliminary study, we reported a 96% success rate for grade 4 cystocele at a follow-up of 34 months. The current modifications were designed to address the midurethral complex and improve postoperative continence in this complex group of patients.

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.

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