Urogynecology: Evidence-Based Clinical Practice 2nd ed.

9. Surgery for Urodynamic Stress Incontinence

Kate H. Moore1

(1)

Department Obstetrics & Gynaecology, St George Hospital, Kogarah, New South Wales, Australia

Abstract

Prior to the late 1960s, patients who leaked when they coughed usually underwent an anterior colporrhaphy (anterior repair) with a bladder neck buttress. Urodynamic testing was not commonplace until the late 1970s.

Introduction

Prior to the late 1960s, patients who leaked when they coughed usually underwent an anterior colporrhaphy (anterior repair) with a bladder neck buttress. Urodynamic testing was not commonplace until the late 1970s.

Once urodynamic studies were introduced, it was realized that coughing can provoke a detrusor contraction. Thus, many women who underwent anterior repair did not obtain cure (because they had an element of detrusor overactivity). This poor success rate was one of the reasons that gynecologists became interested in performing urodynamic tests (to improve their surgical cure rates) and was one stimulus to the establishment of urogynecology as a subspecialty.

Once a diagnosis of urodynamics stress incontinence has been made, without substantial voiding difficulty, any detrusor overactivity has been thoroughly treated; then this chapter describes the surgical options available.

Bladder Neck Buttress

This procedure is still used in highly selected cases. For example, if a woman mainly complains of prolapse due to cystocele but is found to have a minor element of stress incontinence on urodynamic testing, then it may be reasonable to perform this procedure. This is particularly true if an elderly woman with prolapse and stress incontinence is found to have an underactive detrusor at urodynamics; one may counsel her that a simple repair with buttress for her stress incontinence is not likely to cause voiding difficulty. The evidence for this comes from retrospective case series, rather than randomized controlled trial [13].

The bladder neck buttress involves the following (see Fig. 9.1):

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Figure 9.1

Bladder neck buttress procedure. The sutures pass deeply through the periurethral endopelvic fascia on the posterior aspect of the symphysis pubis (arrow) (Reprinted with permission from Thompson and Rock [28])

·               Inject local anesthetic with adrenaline into subcutaneous plane.

·               Insert urethral catheter with 5 ml balloon (to delineate urethrovesical junction).

·               Dissect vaginal epithelium off the bladder and proximal urethra.

Use a small needle with 1 Vicryl or nonabsorbable suture.

·               Place three mattress sutures at the bladder neck and proximal urethra to plicate (or buttress) the periurethral fascia that borders the levator hiatus.

The goal is to assist closure of an open bladder neck, but if done correctly, it will also elevate the urethrovesical junction in the retropubic space. This procedure was first described by Kelly in 1913, who reported an initial subjective success rate of 90 %, but this decreased to 60 % subjectively continent over 5 years.

For further details of associated anterior repair for cystocele, see Chap. 10 (prolapse). For postoperative management of voiding function, see “Colposuspension” below.

Colposuspension

From about 1970 until the late 1990s, the most common procedure for USI was the colposuspension. This is still a very useful procedure if the patient requires an abdominal procedure for some other reason.

The procedure is mainly indicated for USI in the presence of urethral hypermobility. If previous surgery has created a fixed, nonmobile urethra, consideration should be given to performing an abdomino-vaginal sling or injecting collagen (but see discussion of TVT). The colposuspension is also highly effective in correcting cystocele.

Preoperative Consent Discussion

Before consenting a patient for colposuspension, ensure that she understands fully the 5–15 % risk of developing de novo detrusor overactivity. Patients can be very distressed if they have an operation because they leak when they play tennis but afterward have to void frequently and leak with unpredictable urge, not to mention nocturia. Such angry patients are commonly referred to a tertiary urogynecology unit!

Also, ensure that the patient understands the 2–5 % risk of longer-term voiding dysfunction (with approximately 0.5 % risk of clean intermittent self-catheterization, CISC). Some urogynecologists ask the patient to meet with a nurse continence advisor to explain CISC before carrying out the operation.

Postoperative Convalescence

This is similar to abdominal hysterectomy, for example, the first week at home should be spent in quiet leisure (reading books, watching TV, etc.). The next 5 weeks are “light duties” (including driving locally, ordinary shopping, with regular rest periods). At 6 weeks, normal activity resumes (including intercourse, swimming, light gym exercise) but with no heavy lifting for a further 6 weeks.

Patients want to know the chance of failure. Objective success rates depend very much on the outcome measure chosen. The original series by Burch [5] revealed a cure rate of 93 % (n  =  143) at approximately 2 years, as judged by a stress test at 250 ml and a lateral X-ray with a metal bead chain in the urethra (to look for stress leak or an open bladder neck). The cure rate at a mean of 14 years follow-up (range 10–20 years, n  =  109) was 80 % on 1-h pad testing [2].

The Technique of Colposuspension

This involves the following (see Fig. 9.2):

·               Place a 14–16-gauge catheter (easy to feel vaginally) in the urethra.

·               Inflate 5-ml balloon (30-ml balloon is too big, will get in the way).

·               Make a Pfannenstiel incision.

·               Access the retropubic space (the Cave of Retzius).

·               By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra.

·               The right-handed operator double gloves and places the left hand in the vagina.

·               With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon).

·               Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.

·               Attach each suture to the iliopectineal ligament at the back of the pubic bone.

·               With the surgeon’s left hand lifting up the vagina, the assistant ties the sutures onto the iliopectineal ligament.

·               The surgeon dictates the degree of tension so as not to overcorrect (tissue should not be taut, just comfortably elevated).

·               Insert a drain to the retropubic space.

·               Insert suprapubic catheter and empty the bladder (no vaginal pack).

Immediate Complications of Colposuspension

·               Hemorrhage into the retropubic space, with a transfusion risk of about 0.5 %

·               Trauma to the bladder (inadvertent cystotomy) requiring repair and subsequent urethral catheter for 7–10 days, approximately 2–3 %

Long-Term Complications of Colposuspension

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Figure 9.2

Three permanent sutures are (a) placed through the endopelvic fascia on each side of the urethra and (b) passed through the iliopectineal ligament of Cooper

·               Enterocele or rectocele (7–17 %) (but 25 % at 14 years [1])

·               Dyspareunia (4 %) because of acute retropubic angle of the anterior vaginal wall

·               Detrusor overactivity (5–15 %) (but note 22 % incidence in Langer et al. [16])

·               Recurrent bacterial cystitis (1–2 %) (but 5 % at 12 years, Langer et al. [16], and at 14 years [2])

·               Voiding difficulty (2–5 %)

Postoperative Management for Colposuspension

·               Free drainage of SPC for 36–48 h; patient unlikely to void due to pain of incision over this time frame.

·               Commence trial of void at approximately 36 h, if patient is ambulant.

·               Once residual volumes is less than 100 ml on three consecutive occasions, usually by day 5 post-op, remove suprapubic catheter.

Double Voiding Technique

·               If residuals are gradually getting lower but still not <100 ml at day 4–5, teach patient to:

·                      Void the first time in normal position.

·                      Stand up and rotate the pelvis a few times to stimulate the afferent nerves.

·                      Sit down and lean forward with elbows on knees.

·                      “Drop” or purposefully relax the pelvic floor muscles.

·                      Remain so for 2–3 m, perhaps read a magazine, and await further flow.

This often will produce another 50–100 ml, sufficient to give residual <100.

How to Manage Short-Term Voiding Difficulty

Note that the literature often does not define what is meant by “voiding difficulty.” In this text, “short-term voiding difficulty” means the management of a temporary suprapubic catheter (SPC), or self-catheterization, for up to 4 weeks. “Long-term voiding dysfunction” means that the temporary SPC required removal, and thus CISC was instigated, from 4 weeks to permanently.

·               If patient is not voiding to completion by fifth postoperative day and not suffering from persistent wound pain (hematoma/ infection), able to defecate fully (no impacted feces or perineal pain from other repair), urine is not infected, double-emptying technique is being used, but otherwise well and ready to plan discharge from hospital:

·               Discard the drainage bag.

·               Attach a Staubli valve or Flip Flow valve (Fig. 9.3) to the SPC.

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Figure 9.3

Witches’ hat urine collection device and Staubli/Flip Flow valves

·               Teach patient to record own voided volumes and residual volumes on chart.

·               After training for 12–24 h, using a “witches’ hat” graduated collecting device placed in the toilet (Fig. 9.3).

·               Send her home for 3 or 4 days to continue trial of void in home toilet.

·               Review back in clinic in 3 or 4 days with her residual volume chart.

Majority of patients will void well with this method.

How to Manage Long-Term Voiding Dysfunction

·               If unable to void after 2–3 weeks of home trial of void, the SPC site will become inflamed and painful.

·               If patient is almost voiding normally, flucloxacillin 500 mg TDS may help to preserve the SPC for a few more days.

·               After this, patient should be trained in clean intermittent self-catheterization (CISC), by a specialist nurse continence advisor because the SPC site will become inflamed.

·               Follow-up with a voided volume and residual chart, kept for 24 h prior to each visit, should be every 2 weeks thereafter. If the bladder is kept well emptied by CISC, spontaneous resolution of the voiding dysfunction often occurs over 3 months.

·               Bad prognostic features are:

·                      Patients with previous pelvic radiotherapy

·                      Patients taking psychotropic drugs with anticholinergic properties

·                      Patients who have undergone radical bowel resection with denervation of pelvic nerves

The Abdomino-Vaginal Sling

Also known as the pubovaginal sling, this procedure is the time-honored operation for patients with previous failed continence surgery, particularly if:

·               There is persistent hypermobility on vaginal examination and videourodynamics (VCU).

·               If the urethra is fixed in the retropubic space (on VE and VCU) but the urethra closure pressure is low (below 20 cm) or the Valsalva leak point pressure is low (below 60 cm), then the abdomino-vaginal sling is worthwhile.

Note that if the urethra is fixed in the retropubic space but the urethral closure pressure or Valsalva leak point pressure is normal, then collagen/Macroplastique injections may be worthwhile; see later section this chapter.

Preoperative Consent Discussion

This discussion is similar to that for the colposuspension, except that risk of voiding difficulty/dysfunction is probably higher, mean of 12.5 % (range 3–32 %); risk of de novo detrusor overactivity is similar (mean risk 10 %, range 4–18 %). The objective success rate after previous failed procedures is 86 % (all data from Jarvis [13]).

After a procedure involving a Pfannenstiel incision and a vaginal incision, the first “quiet” week of the convalescence period should probably increase to 2 weeks, but light duties should still be appropriate at 6 weeks.

The abdomino-vaginal sling procedure entails the following (see Fig. 9.4):

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Figure 9.4

(a) Harvesting a strip of rectus abdominus fascia 13  ×  2.5 cm. (b) Placement of autologous sling under urethra and then attachment to rectus abdominus under minimal tension

·               Insert 16-G Foley catheter into bladder with 5 ml balloon.

·               Make a wide Pfannenstiel incision.

·               Harvest a strip of rectus abdominus fascia 13  ×  2 cm; wrap in moist gauze.

·               Dissect down to the retropubic space as for a colposuspension.

·               From below, incise the anterior vaginal wall as for an anterior repair but should only need to dissect about 3 cm below the urethrovesical junction.

·               Working on a flat sterile surface; insert nylon 1.0 sutures to the four corners of the rectus sheath strip.

·               Insert a long narrow Bosman’s packing forcep downward from the retropubic space into the vagina, emerging at the urethrovesical junction (guided by the balloon of the catheter).

·               Bring the nylon sutures attached to the strip of sheath up into the abdominal wound (first on the left, then on the right).

·               Place the fascia strip under the urethrovesical junction.

·               Apply 2.0 Vicryl tacking sutures to the fascia at the edges of the vaginal wound to maintain the position of the strip at the urethrovesical junction.

·               Lift the nylon sutures into the abdominal wound so as to place the fascial strip just under the urethra, with absolutely no tension.

·               Tie the nylon sutures at the four corners of the strip to the rectus abdominus fascia.

·               Close the abdominal and vaginal wounds in the traditional fashion.

·               Insert SPC. Insert drain to the retropubic space. Pack is not mandatory.

Postoperative management is as for a colposuspension. Some surgeons perform this sling procedure using artificial mesh, but most prefer to harvest the patient’s own (autologous) fascia. The relative risk of mesh erosion using artificial mesh has not been well published; there are no randomized trials.

Historical Note: Stamey Needle Suspension and Raz/Pereyra/Gittes Procedures

In 1973, Stamey described a minimally invasive procedure to correct stress incontinence. This involved two passages of a long needle behind the pubic bone; after the first pass, a polypropylene suture was threaded through the needle. An arterial graft pledget was threaded onto the vaginal end of this suture (Fig. 9.5). A second pass of the needle brought the suture back up behind the pubic bone, capturing a thick bridge of periurethral tissue; the suture was tied over the rectus sheath (then repeated on other side). The Raz, Pereyra, and Gittes modifications did not use the nonabsorbable pledget.

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Figure 9.5

Stamey bladder neck suspension pledget removed from the vagina of a patient 3 years after the procedure

Initially, the results of these procedures showed great promise, with 2-year objective cure rates of 70–86 % in the early 1990s Jarvis [13]. However, over time, these cure rates were not sustained. For example, 130 patients reviewed at 5.5 years revealed a cure rate of 50 %, but 11.5 % had never become continent, and 38.5 % had recurrence 6–90 months after the procedure Conrad et al. [7]. Of 30 patients (interviewed and 1-h pad test) at 10 years, only 30 % remained both subjectively and objectively dry Mills et al. [19]. It was thought that the pledgets/sutures had pulled through the periurethral tissue. Postoperative weight gain was associated with a higher failure rate. In a small percentage of cases, the pledget later eroded through the periurethral tissue and migrated into the vagina (Fig. 9.5).

These procedures are not considered further in this text but illustrate the importance of long-term scrutiny of the efficacy of any new surgical procedure. Beware rapid introductions of new operations!

Paravaginal Repair

The paravaginal repair is regarded as an alternative method for repair of cystocele but has also been used to treat USI—see Chap. 10 on prolapse. As regards USI, a single report showed a 97 % subjective cure of stress incontinence at 3–4 years follow-up. Objective tests were not performed Shull and Baden [25].

Laparoscopic Colposuspension

The laparoscopic colposuspension was first described in 1991. A review of 27 studies of the procedure between 1991 and 1998 (n  =  1,024) showed that only four studies used objective outcome measures, yielding a cure rate of 75 % (range 60–89 %) at a mean follow-up of 19 months (range 6–36 months, Chaliha and Stanton [6]). Ten randomized controlled trials have now compared this operation with the open colposuspension. Overall, the objective cure rate (cough stress test or pad test) at 18 months was significantly lower for the laparoscopic operation (RR 0.91, 95 % CI, 0.86–0.96), which was also shown in the studies that judged success on urodynamic testing. The risk of bladder injury for laparoscopic cases was 3 % (0–10 %). Since the advent of the TVT, use of this operation when no other laparoscopic procedures are to be performed is not recommended by the Cochrane Review or the International Consultation on Incontinence [26] and is hard to justify, considering the expense of the equipment/disposable items and questionable/unknown long-term success rates.

The TVT and Transobturator Tape

The tension-free vaginal tape procedure has changed the management of USI. As originally designed, it is performed under local anesthetic, and most cases can be performed as an outpatient procedure. For a registrar training in “the TVT era,” it may be hard to understand just what a revolution has taken place. For 30 years (late 1960s to late 1990s), the colposuspension was the “gold standard” continence procedure. Although highly effective, it involved a 5-day stay in the hospital, a 10–15 % chance of detrusor overactivity, and a 2–5 % chance of voiding difficulty (as above), not to mention the usual 6 weeks postoperative convalescence.

As outlined, the arrival of the Raz/Stamey/Pereyra/Gittes procedure brought the prospect of freedom from the Pfannenstiel incision and avoidance of prolonged convalescence. Unfor­tunately, these operations did not stand the test of time.

As will be shown, we now have 11-year objective data for the TVT, revealing similar efficacy to the colposuspension.

Preoperative Consent Advice

The TVT confers a 5–6 % risk of detrusor overactivity and a 1–2 % risk of short-term voiding difficulty, with a 0.5 % risk of long-term voiding dysfunction. Postoperatively, patients should rest for 1 week or until comfortable, then light duties for 3 weeks.

The TVT under local anesthesia (LA) involves the following (see Fig. 9.6):

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Figure 9.6

(a) TVT tape, guide wire, and introducer device. (b) Lateral view of TVT tape under the urethra (Reprinted with permission from Gynecare)

·               Prepare 100 ml of LA solution, for example, prilocaine 0.25 % or Naropin 0.2 % with 1 ml of 1/1,000 adrenaline.

·               Anesthetist to give antibiotic prophylaxis against the insertion of a mesh into vaginal environment and administer midazolam or propofol IV infusion for sedation.

·               Empty the bladder.

·               Inject LA above the pubic bone, into the retropubic space (21-gauge spinal needle), then underneath the pubic bone, then into the anterior vaginal wall, 2 cm below the urethra.

·               Vertically incise the anterior vaginal wall, 2 cm below the urethra, for about 1.5 cm.

·               Dissect under the vaginal skin, toward the pubic bone, left and right.

·               Make a 1-cm incision at the suprapubic LA insertion sites, bilaterally.

·               Insert guide wire into 16-G Foley catheter and pass into bladder.

·               Assistant holds the guide/catheter to the ipsilateral side for insertion of TVT tape, to move the urethrovesical junction out of the way.

·               Assemble the TVT introducer (Fig. 9.6a).

·               Hold edge of vaginal incision with fine Gillies forceps; insert TVT needle into incision.

·               Direct needle about 30° to the lateral; aim upward toward the abdominal wound.

·               Push needle firmly through the urogenital diaphragm, under strict control.

·               Drop the handle of the introducer so the needle is felt to be running up the back of the pubic bone. Very gradually advance the needle up in the retropubic space until it emerges at the abdominal wound.

·               Perform cystoscopy to ensure no needle puncture of bladder; empty bladder.

·               Repeat procedure for the other side.

·               After second cystoscopy, do not empty bladder.

·               Stop IV sedation; prepare patient to cough.

·               Elevate tape so it lies just under urethra (Fig. 9.6b), but insert fine scissors between tape and urethra.

·               Patient coughs repeatedly; gradually elevate the tape so that only a few drops of fluid spill over the edge of the meatus at the height of the cough (no projectile spurt).

·               Assistant removes plastic covers of the tape while surgeon holds scissors to maintain tape position under the urethra (otherwise, removal of the plastic tape covers can cause further elevation of the tape itself).

·               Empty the bladder; close all incisions. No pack. No catheter.

Is the Cough Test Necessary?

The very name of the operation, “tension-free vaginal tape” was based on meticulous attention to placing the tape so that a drop of urine was just seen at the meatus during the cough test. However, an RCT of 93 women with 2-year follow-up revealed that not using a cough test did not affect any of the objective outcome measures [20].

Postoperative Instructions

The patient should drink as much as she desires but not force fluids. She should void whenever she feels the desire, not at a set time. If she has not voided within 4 h, bladder scan to check volume.

After each void, check residual. If two residuals are less than 100 ml and patient is comfortable, discharge home. If residuals are greater than 200, insert Foley catheter overnight; remove 6 A.M.; restart.

If residuals >100 ml but <200 ml, ask patient to double void and rescan; generally residuals will be less than 100 after a double void. Patient should be taught this technique.

Once patient voids completely and is comfortable, discharge. Review at 6 weeks: repeat uroflowmetry/post-void ultrasound residual to check for asymptomatic voiding difficulty.

Outcome Data for the TVT

The first objective report of medium-term follow-up (3 years) showed a dry rate on pad test of 93 % Ulmsten et al. [29]. Five-year follow-up showed 85 % objective cure rate Nilsson et al. [21], with the same authors finding a 91 % objective cure rate on pad test at a mean of 11 years (subjective cure 77 %) [22]. In this report, the de novo rate of OAB symptoms was 4.7 %. Tape exposure occurred in 3.1 %, requiring resection/ closure in 1.6 % due to discomfort. A recent abstract of 11-year data showed similar results. The largest RCT [30] showed no significant difference between the TVT and the colposuspension at 6 months and at 2 years [Ward and Hilton, 31].

Controversy still exists about the importance of performing the procedure under local anesthetic. As mentioned, the cough test was shown on RCT not to affect continence outcomes or risk of voiding dysfunction. The efficacy of TVT in the low-pressure urethra appears to be lower than in primary procedures (37–86 % cure versus 88–94 % cure in primary cases). For full review, see Atherton and Stanton [4].

The risks of TVT include:

·               Intraoperative perforation of bladder (4–6 %)

·               Retropubic hematoma (2.4 %)

·               De novo detrusor overactivity (5–6 %)

·               Urinary tract infection (4–17 %)

·               Short-term voiding difficulty (2–3 %)

·               Long-term voiding dysfunction (<0.5 %)

·               Tape exposure (3.1 %)

·               Tape resection due to discomfort (1.6 %)

·               From manufacturer’s log of rare complications in 260,000 cases:

o          Bowel perforation 0.007 % (three deaths worldwide)

o          Major vascular injuries 0.012 % (two deaths worldwide)

o          Urethral penetration 0.007 %

Some surgeons manage short-term voiding difficulty by cutting the tape; the optimum time for performing this is controversial. Continence is often preserved because the lateral arms of the tape have already become enmeshed in the periurethral tissue, providing residual support.

The Transobturator Tape

Because the TVT involves penetration of the retropubic space “blindly” (without direct vision), the above small but important risks of bowel/vascular injury are not unexpected. The transobturator tape was developed partly to avoid these risks and partly to avoid the risk of penetrating the bladder in the retropubic space (thus, cystoscopy was thought to not be required, and operating time is shorter).

In 2001, Delorme [9] introduced the transobturator tape (TOT) in which a spiral-shaped needle applicator penetrates the upper margin of the obturator foramen and then is passed to the suburethral space (see Fig. 9.7, the so-called “outside in” approach). De Leval then modified the procedure in 2003 [8] to be an “inside out” approach called the TVT-O, whereby the inner aspect of the obturator foramen is penetrated from within the vagina.

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Figure 9.7

(a) Insertion of transobturator (Monarch) tape into the obturation foramen (“outside in”). (b) Comparison of insertion of TVT into retropubic space

Both the TOT and the TVT have been the subject of numerous RCTs comparing the new procedure with the TVT (see Smith et al. [26]). In many trials the outcomes are not significantly different. Only Araco et al. [3], who performed stratified randomization between mild and severe incontinence, showed 100 % cure for the TVT versus 66 % cure for TVT-O in those with severe incontinence. The most recent example of this is Laurikainen et al. (2011) [17], a 5-year study of TVT versus TVT-O, comprising 273 patients reviewed at 5 years in which the pad test was negative in 89 and 93 % of TVT and TVT-O, respectively.

As regards the issue of severe stress incontinence versus mild, Schierlitz et al. [24] recently performed an RCT of women with a low-pressure urethra (MUCP  <  20 cm), comprising 164 women at 3 years. The primary outcome was symptomatic stress incontinence requiring repeat surgery, which occurred in 20 % of the women who had a Monarc TOT versus 1.4 % in the TVT group. They concluded that tests seeking a low urethral closure pressure should be used to determine the correct minimally invasive sling. Other considerations are that pain at the site of the adductor longus insertion on the inferior ramus of the pubic bone is problematic in the transobturator procedures, and the risk of mesh erosion is also greater than TVT at 6.2 % Duval et al. [10].

A Word About the New “Mini-slings”

In the last 3–4 years, a variety of new “mini-slings” have been introduced, which do not require passage into either the retropubic space or the obturator foramen. Rather, the short mesh tape is inserted into the suburothelial fascia on either side of the urethra. It was hoped that these new procedures would be outpatient procedures with absolutely no risk of voiding dysfunction. Unfortunately, a systematic review of 9 studies of these slings has shown a much higher failure rate with a relative risk of repeat surgery of 6.72, CI 2.39–18.89, so they have shown no useful benefit, [1] and most urogynecologists do not employ these new devices.

The Use of Bulking Agents for USI

Bulking agents such as GAX collagen, Macroplastique, and Durasphere are attractive because they can be performed as a day-only or outpatient procedure, have minimal risk of provoking voiding difficulty, and can be performed under local anesthesia with sedation. Unfortunately the cure rate for this procedure is variable, depending upon the agent used, the type of stress incontinence, and the number of repeat injections.

Controversy exists as to whether bulking agents should be reserved for patients with a relatively fixed bladder neck, mostly after previous continence surgery. This is probably the “standard teaching,” although several trials demonstrate reasonable improvement rates in patients with a hypermobile bladder neck.

A further controversy concerns whether patients with a low urethral closure pressure (<20 cm) should be offered bulking agents. Gorton et al. [11] showed clearly that the success rate over 5 years was significantly poorer when GAX collagen was used in women with a low urethral closure pressure. The median duration of continence for those with a low-pressure urethra was 15 months, compared to 72 months in the remainder. On Cox regression analysis, a low-pressure urethra was strongly predictive of failure (p  =  0.03). Such data are not known for the other agents.

The procedure involves injecting approximately 4–6 ml of the bulking agent into the midurethra, under the mucosa, via cystoscopic needle, either transurethrally or periurethrally so as to “bulk up” the midurethra (Fig. 9.8).

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Figure 9.8

Bulking agent injected into the submucosa

The main features of each bulking agent are as follows.

GAX Collagen (Contigen)

This is made of bovine dermal collagen, cross-linked with glutaraldehyde, to reduce antigenicity, first described in 1989.

·               Allergic reactions to the bovine material do occur so that skin testing is required 30 days beforehand to exclude allergic response in each patient.

·               Collagen is inserted under cystoscopic control—either via a trans-perineal approach, using a spinal needle, to inject periurethrally, or using a specialized cystoscopic needle, to inject transurethrally.

·               Most surgeons inject at 6 o’clock, then 9–10 o’clock, then 2–3 o’clock.

·               Each ampoule contains 2.5 ml of GAX collagen and costs approximately 1,200 euros.

·               Because bovine collagen is degraded over time, incontinence often recurs at about 2 years; thus, “top-up” doses are commonly performed.

·               Most reports of efficacy do not use objective measure.

·               Khullar et al. [14] showed that (on 1-h pad test) in a group of 28 elderly women (age >62, mean 76), 76 % were cured at 1 month, falling to 48 % at 2 years. The effect of urethral closure pressure upon success was not discussed; 16/28 had undergone previous continence surgery.

Macroplastique

This is a hydrogel-suspended cross-linked polydimethylsiloxane elastomer (silicone rubber particles), first described in 1991.

·               Because the particles are 100–450 μm in diameter, they do not migrate and are quickly encapsulated in fibrin.

·               It is not known to produce allergic reaction.

·               Initially, injection was via cystoscopic needle, transurethrally or trans-perineally, at 2, 6, and 10 o’clock. Each vial costs 320 lb; two are normally used.

·               In 2000, a simple applicator with specialized needle was described (see Henalla et al. [12]) which avoids the need for cystoscopic visualization of the injection site (Fig. 9.9). A specialized injection gun is also provided.

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Figure 9.9

Macroplastique application device

·               On subjective score, 74 % of 40 women were dry at 3 months Henalla et al. [12].

·               Using objective urodynamic measures, 59 % of 32 women were dry at 12 months; 28 of these had undergone previous continence surgery Koelbl et al. [15].

·               Postoperative short-term voiding difficulty and detrusor overactivity do occur with this procedure, although less commonly than for other procedures. For full review, see ter Meulen et al. [27]

Durasphere

This is a suspension of carbon-coated zirconium beads, first reported in 2001.

·               It is not known to be allergenic.

·               Using the Stamey score to grade incontinence (a nonvalidated measure), 80 % of 176 women had “improvement” of at least one Stamey grade at 12 months (versus 69 % of 188 women given GAX collagen; difference not significant) Lightner et al. [18]. Long-term studies involving objective outcome measures are awaited.

The Cochrane Review of periurethral injection therapy for urinary incontinence [Pickard et al. 23] found insufficient evidence to recommend this as a first-line therapy (implying that it should be reserved for those with previous continence surgery). The current Cochrane Review Web site does not give an overview of the efficacy of injectables as a whole; only small reviews about technical matters are given. Overall, none of the comparative trials revealed significant differences between the different agents in terms of efficacy. In a patient with comorbidity that precludes anesthesia, bulking agents “may represent a useful option for relief of symptoms for a 12 month period although repeat injections are likely to be required to achieve a satisfactory result.” [23]

Conclusions

The surgical management of USI has advanced tremendously in the last two decades. Each procedure still has risks, requiring meticulous preoperative counseling. The most appropriate procedure must be chosen for each patient, considering her previous surgical history, her willingness to undergo minimally invasive versus major surgery, and her perioperative risk factors. Careful and sympathetic management of postoperative detrusor overactivity, voiding dysfunction, and rarer complications, is vitally important.

References

1.

Abdel-Fatteh M, Ford J, Lim CP, Madhubrata P. A systematic review and meta-analysis of single-incision mini-slings versus standard mid-urethral slings in surgical management of female stress urinary incontinence. Neurourol Urodyn. 2011;30:802–3.

2.

Alcalay M, Monga A, Stanton SL. Burch colposuspension: a 10–20 year followup. Br J Obstet Gynaecol. 1995;102:740–5.PubMedCrossRef

3.

Araco F, Gravante G, Sorge R, et al. TVT-O vs TVT; a randomized trial in patients with different degrees of urinary stress incontinence. Int Urogynecol J. 2008;19:917–26.CrossRef

4.

Atherton MJ, Stanton SL. The tension free vaginal tape reviewed: an evidence based review from inception to current status. Br J Obstet Gynaecol. 2005;112:534–46.CrossRef

5.

Burch JC. Cooper’s ligament urethrovesical suspension for stress incontinence. Am J Obs Gynecol. 1968;100:764–74.

6.

Chaliha C, Stanton SL. Urethral sphincter incompetence. In: Stanton SL, Monga AK, editors. Clinical urogynaecology. 2nd ed. Harcourt: Churchill Livingstone; 2000. p. 201–18. Chapter 19.

7.

Conrad S, Pieper A, Fernandez de la Maza S, Busch R, Huland H. Long-term results of the Stamey bladder neck suspension procedure: a patient questionnaire based outcome analysis. J Urol. 1997;157:1672–7.PubMedCrossRef

8.

DeLeval J. Novels surgical technique for the treatment of female stress urinary incontinence; transobturator vaginal tape inside-out. Eur Urol. 2003;44:724–30.CrossRef

9.

Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treatment of stress urinary incontinence in women. Prog Urol. 2001;11:1306–13.PubMed

10.

Deval B, Ferchaux J, Berry R, Gambino S, Gofu C, Rafii A, Haab F. Objective and subjective cure rates after trans-obturator tape (OBTAPE®) treatment of female urinary incontinence. Eur Urol. 2006;49:373–7.PubMedCrossRef

11.

Gorton E, Stanton S, Monga A, Wiskind AK, Lentz GM, Bland DR. Periurethral collagen injection: a long-term follow-up study. BJU Int. 1999;84:966–71.PubMedCrossRef

12.

Henalla SM, Hall V, Duckett JRA, Link C, Usman F, Tromaus PM, et al. A multicentre evaluation of a new surgical technique for urethral bulking in the treatment of genuine stress incontinence. Br J Obstet Gynaecol. 2000;107:1035–9.CrossRef

13.

Jarvis GJ. Surgery for genuine stress incontinence. Br J Obstet Gynaecol. 1994;101:371–4.PubMedCrossRef

14.

Khullar V, Cardozo LD, Abbot D, Anders K. GAX collagen in the treatment of urinary incontinence in elderly women: two year follow up. Br J Obstet Gynaecol. 1997;104:96–9.PubMedCrossRef

15.

Koelbl H, Sax V, Doefler D, Haesler G, Sam C, Hanzal E. Transurethral injection of silicone microimplants for intrinsic urethral sphincter deficiency. Obstet Gynecol. 1998;92:332–6.PubMedCrossRef

16.

Langer R, Rone-El R, Newman M, Herman A, Carpi D. Detrusor instability following colposuspension for urinary stress incontinence. Br J Obstet Gynaecol. 1988;95:607–10.PubMedCrossRef

17.

Laurikainen E, Takala T, Aukee P, et al. Retropubic TVT compared with Transobturator TVT (TVTO) in treatment of stress urinary ­incontinence: 5 year results of a randomized trial. Neurourol Urodyn. 2011;30:802–3.

18.

Lightner DJ, Calvosa C, Andersen R. A new injectable bulking agent for treatment of stress urinary incontinence: results of a multicenter, randomized, controlled double blind study of Durasphere. Urology. 2001;58:12–5.PubMedCrossRef

19.

Mills R, Persad R, Handley Ashken M. Long term follow up results with the Stamey operation for stress incontinence of urine. Br J Urol. 1996;77:86–8.PubMedCrossRef

20.

Moore KH, Shahab RB, Walsh CA, et al. Randomized controlled trial of the cough test versus no cough test in the tension-free vaginal tape procedure: effect upon voiding dysfunction and 12-month efficacy. Int Urogynecol J. 2011;23:435–41.PubMedCrossRef

21.

Nilsson CG, Kuuva N, Falconer C, Rezapour M, Ulmsten U. Long-term results of the tension-free vaginal tape (TVT) procedure for surgical treatment of female stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2001;2 Suppl:S5–8.CrossRef

22.

Nilsson CG, Palva K, Rezapour M, Falconer C. Eleven years prospective follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19(8):1043–7. Epub 2008 Jun 6.PubMedCrossRef

23.

Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N’Doy J (2003) Periurethral injection therapy for urinary incontinence in women. Cochrane Database Syst Rev (2):CD003881. DOI: 10.1002/14651858.CD003881.

24.

Schierlitz L, Dwyer PL, Rosamilia A, et al. Three year follow up of tension free tape compared with transobturator tape in women with stress urinary incontinence and intrinsic sphincter deficiency. Obstet Gynecol. 2012;119:321–7.PubMedCrossRef

25.

Shull BL, Baden WF. A six year experience with paravaginal defect repair for stress urinary incontinence. Am J Obstet Gynecol. 1989;160:1432–40.PubMedCrossRef

26.

Smith ARB, Dmochowski R, Hilton P, et al. Surgery for urinary incontinence in women chapter 14. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence, 4th international consultation on incontinence. Health Publication Ltd; 2009. p. 1191–272.

27.

Ter Meulen PH, Berghmans LCM, van Kerrebroeck PEVA. Systematic review: efficacy of silicone microimplants (macroplastique) therapy for stress urinary incontinence in adult women. Eur Urol. 2003;44:573–82.PubMedCrossRef

28.

Thompson JD, Rock JA, editors. Te Linde’s operative gynecology. 7th ed. Philadelphia: Lippincott Williams & Wilkins; 1992.

29.

Ulmsten U, Johnson P, Rexapour M. A three year followup of tension free vaginal tape for surgical treatment of female stress urinary incontinence. Br J Obstet Gynaecol. 1999;106:345–50.PubMedCrossRef

30.

Ward KL, Hilton P. Prospective multicentre randomised trial of tension-free tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002;325:67–70.PubMedCrossRef

31.

Ward K, Hilton P. A randomised trial of colposuspension and tension-free vaginal tape (TVT) for primary genuine stress incontinence – 2 year followup. Am J Obstet Gynecol. 2004;190:324–31.PubMedCrossRef