Burch Colposuspension

Surgery is usually the most effective way of curing urodynamic stress incontinence and a 90% cure rate can be expected for an appropriate, properly performed primary procedure. Surgery for urodynamic stress incontinence aims to elevate the bladder neck and proximal urethra into an intra-abdominal position, to support the bladder neck and align it to the posterosuperior aspect of the pubic symphysis, and in some cases to increase the outflow resistance. Undoubtedly the results of suprapubic operations such as the Burch colposuspension or Marshall-Marchetti-Krantz procedure are better than those for the traditional, anterior colporrhaphy with bladder neck buttress [111]. Numerous operations have been described and many are still performed today. Common operations for urodynamic stress incontinence are listed in Table 49.11.

A systematic review of the effectiveness of surgery for stress incontinence in women [112] revealed only 11 randomized controlled trials, 20 non-randomized trials and 45 retrospective studies. This review showed that evidence as to the effectiveness of surgery for stress incontinence is weak, but that colposuspension is more effective and long lasting than anterior colporrhaphy or needle suspension. Reliable data on the frequency of complications following surgery were lacking but repeat operations were noted to be less successful than first procedures.

Table 49.11 Operations for urodynamic stress incontinence

Vaginal

Anterior colporrhaphy +/- Kelly/Pacey suture Urethrocliesis Urethral bulking agents Retropubic tape procedures Transobturator tape procedures Abdominal

Marshall-Marchetti-Krantz procedure Burch colposuspension

Laparoscopic Colposuspension

Combined Sling

Endoscopic bladder neck suspension, for example, Stamey, Raz

Complex Neourethra Artificial sphincter Urinary diversion anterior colporrhaphy

Anterior colporrhaphy is still performed for stress incontinence. Although it is usually the best operation for a cystourethrocele, the cure rates for urodynamic stress incontinence are poor compared to suprapubic procedures [113]. Since prolapse is relatively easier to cure than stress incontinence, it is appropriate to perform the best operation for incontinence when the two conditions coexist.

marshall-marchetti-krantz

The Marshall-Marchetti-Krantz procedure is a suprapu-bic operation in which the paraurethral tissue at the level of the bladder neck is sutured to the periostium and/or perichondrium of the posterior aspect of the pubic sym-physis. This procedure elevates the bladder neck but will not correct any concomitant cystocele. It has been largely superseded by the Burch colposuspension because its complications include osteitis pubis in 2-7% of cases.

colposuspension

The Burch colposuspension has been modified by many authors, since its original description [114]. Until recently colposuspension has been the operation of choice in primary urodynamic stress incontinence as it corrects both stress incontinence and a cystocele. It may not be suitable if the vagina is scarred or narrowed by previous surgery. The operation is performed via a low transverse suprapubic incision. The bladder, bladder neck and proximal urethra are dissected medially off the underlying paravaginal fascia and three or four pairs of non-absorbable or long-term absorbable sutures are inserted between the fascia and the ipsilateral iliopectineal ligament. Haemostasis is secured and the sutures are tied, thus elevating the bladder neck and bladder base (Fig. 49.22). Simultaneous hysterectomy does not improve results but if there is uterine pathology (menorrhagia or uterovaginal prolapse) then a total abdominal hysterectomy should be performed at the same time. Postoperatively a suction drain is left in the retropu-bic space and a suprapubic catheter is inserted into the bladder. Perioperative antibiotics and/or subcutaneous heparin may be employed. In virtually all reported series comparing results of a Burch colposuspension with any other procedure to cure urodynamic stress incontinence, the results of the colposuspension have been the best.

Whilst the colposuspension is now well recognized as an effective procedure for stress incontinence it is not without complications. Detrusor overactivity may occur de novo or may be unmasked by the procedure [115] which may lead to long-term urinary symptoms. Voiding difficulties are common postoperatively and although they usually

Symphysis pubis

Ileopectineal ligament

Bladder

Fig. 49.22 Modified Burch colposuspension.

resolve within a short time after the operation, long-term voiding dysfunction may result. In addition, a rectoen-terocele may be exacerbated by repositioning the vagina [116]. However, the colposuspension is the only incontinence operation for which long-term data are available. Alcalay et al. [117] have reported a series of 109 women with an overall cure rate of 69% at a mean of 13.8 years.

laparoscopic colposuspension

Minimally invasive surgery is attractive and this trend has extended to surgery for stress incontinence. Although many authors have reported excellent short-term subjective results from laparoscopic colposuspension [118], early studies have shown inferior results to the open procedure [119,120].

More recently two large prospective randomized controlled trials have been reported from Australia and the United Kingdom comparing laparoscopic and open colpo-suspension. In the Australian study 200 women with uro-dynamic stress incontinence were randomized to either laparoscopic or open colposuspension [121]. Overall there were no significant differences in objective and subjective measures of cure or in patient satisfaction at 6 months, 24 months or 3-5 years. Whilst the laparoscopic approach took longer (87 versus 42 min; p < 0.0001) it was associated with less blood loss (p = 0.03) and a quicker return to normal activities (p = 0.01).

These findings are supported by the UK multicentre randomized controlled trial of 291 women with urodynamic stress incontinence comparing laparoscopic to open colpo-suspension [122]. At 24 months intention to treat analysis showed no significant difference in cure rates between

Symphysis pubis

Burch Colposuspension

Ileopectineal ligament

Bladder

Fig. 49.22 Modified Burch colposuspension.

the procedures. Objective cure rates for open and laparoscopic colposuspension were 70.1% and 79.7% respectively whilst subjective cure rates were 54.6% and 54.9%, respectively.

These studies have confirmed that the clinical effectiveness of the two operations is comparable although the cost effectiveness of laparoscopic colposuspension remains unproven. A cost analysis comparing laparoscopic to open colposuspension was also performed alongside the UK study [123]. Healthcare resource use over the first six month follow-up period translated into costs of £1805 for the laparoscopic group versus £1433 for the open group.

It is important that this information is made available to women who are undergoing incontinence surgery as most would prefer their stress incontinence to be cured rather than a reduced hospital stay. In addition it has been well established that the first operation is the one most likely to succeed and therefore it is unfortunate if a good outcome is prejudiced by an inferior operation.

sling procedures

Sling procedures are normally performed as secondary operations where there is scarring and narrowing of the vagina. The sling material can either be organic (rectus fascia, porcine dermis) or inorganic (Mersilene, Marlex, Gore-tex or Silastic). The sling may be inserted either abdominally, vaginally or by a combination of both. Normally the sling is used to elevate and support the bladder neck and proximal urethra, but not intentionally to obstruct it. Sling procedures are associated with a high incidence of side effects and complications. It is often difficult to decide how tight to make the sling. If it is too loose, incontinence will persist and if it is too tight, voiding difficulties may be permanent. Women who are going to undergo insertion of a sling must be prepared to perform clean intermittent self-catheterization postopera-tively. In addition, there is a risk of infection, especially if inorganic material is used. The sling may erode into the urethra or vagina, in which case it must be removed and this can be exceedingly difficult. Early reports of the use of needle suspension patch slings using fascia or Gore-tex suggests a reduced complication rate with similar efficacy but long-term series have been published to date.

retro-pubic tape procedures Tension free vaginal tape

The tension free vaginal tape (TVT, Gynaecare), first described by Ulmsten in 1996 [124], is now the most commonly performed procedure for stress urinary incontinence in the UK and more than one million procedures

Colposuspension Burch
Fig. 49.23 Tension free vaginal (TVT).

have been performed worldwide. A knitted 11 mm x 40 cm polypropylene mesh tape is inserted trans-vaginally at the level of the mid-urethra, using two 5 mm trochars (Fig. 49.23). The procedure maybe performed under local, spinal or general anaesthesia. Most women can go home the same day, although some do require catheterization for short term voiding difficulties (2.5-19.7%). Other complications include bladder perforation (2.7-5.8%), de novo urgency (0.2-15%) and bleeding (0.9-2.3%) [125].

A multicentre study carried out in six centres in Sweden has reported a 90% cure rate at one year in women undergoing their first operation for urodynamic stress incontinence, without any major complications [126]. Long term results would confirm durability of the technique with success rates of 86% at 3 years [127], 84.7% at 5 years [128] and 81.3% at 7 years [129].

The tension free vaginal tape has also been compared to open colposuspension in a multicentre prospective randomized trial of 344 women with urodynamic stress incontinence [130]. Overall there was no significant difference in terms of objective cure; 66% in the tension free vaginal tape group and 57% in the colposuspen-sion group. However, operation time, postoperative stay and return to normal activity were all longer in the col-posuspension arm. Analysis of the long-term results at 24 months using a pad test, quality of life assessment and symptom questionnaires showed an objective cure rate of 63% in the tension free vaginal tape arm and 51% in the colposuspension arm [131]. At 5 years there were no differences in subjective cure (63% in the tension free vaginal tape group and 70% in the colposuspension group), patient satisfaction and quality of life assessment. However, whilst there was a significant reduction in cys-tocele in both groups there was a higher incidence of enterocele, rectocele and apical prolapse in the colposus-pension group [132]. Furthermore, cost utility analysis has also shown that at six months follow up tension free vaginal tape resulted in a mean cost saving of £243 when compared to colposuspension [133].

A smaller randomized study has also compared tension free vaginal tape to laparoscopic colposuspension in 72 women with urodynamic stress incontinence. At a mean follow- up of 20 months objective cure rates were higher in the tension free vaginal tape group when compared to the laparoscopic colposuspension group; 96.8% versus 71.2% respectively (p = 0.056) [134].

SPARC-mid urethral sling suspension system

The SPARC sling system (American Medical Systems) is a minimally invasive sling procedure using a knitted 10 mm wide polypropylene mesh which is placed at the level of the mid-urethra by passing the needle via a suprapubic to vaginal approach [135] Fig. 49.24. The procedure may be performed under local, regional or general anaesthetic. Aprospective multicentre study of 104 women with urodynamic stress incontinence has been reported from France [136]. At a mean follow up of 11.9 months the objective cure rate was 90.4% and subjective cure 72%. There was a 10.5% incidence of bladder perforation and 11.5% of women complained of de novo urgency following the procedure. More recently SPARC has been compared to tension free vaginal tape in a prospective randomized trial of 301 women [137]. At short-term follow-up there were no significant differences in cure rates, bladder perforation rates and de novo urgency. There was, however, a higher incidence of voiding difficulties and vaginal erosions in the SPARC group.

Transobturator Urethral Sling
Fig. 49.24 SPARC-mid urethral sling suspension system.

transobturator sling procedures

The transobturator route for the placement of synthetic mid-urethral slings was first described in 2001 [138]. As with the retro-pubic sling procedures transobturator tapes may be performed under local, regional or general anaesthetic and have the theoretical advantage of eliminating some of the complications associated with the retropubic route. However, the transobturator route may be associated with damage to the obturator nerve and vessels; in an anatomical dissection model the tape passes 3.4-4.8 cm from the anterior and posterior branches of the obturator nerve respectively and 1.1 cm from the most medial branch of the obturator vessels [139]. Consequently nerve and vessel injury in addition to bladder injury and vaginal erosion remain a potential complication of the procedure.

The transobturator approach may be used as an 'inside-out' (TVT-O, Gynaecare) (Fig. 49.25) or alternatively an 'outside-in' (Obtape, Mentor; Monarc, American Medical Systems; Obtryx, Boston Scientific) technique. To date there have been several studies documenting the short-term efficacy of transobturator procedures but less long-term evidence. Initial studies have reported cure and improved rates of 80.5% and 7.5% respectively at 7 months [140] and 90.6% and 9.4% respectively at 17 months [141].

More recently the transobturator approach (TVT-O) has been compared to the retropubic approach (TVT) in an Italian prospective multicentre randomized study of 231 women with urodynamic stress incontinence [142]. At a mean of 9 months subjectively 92% of women in the TVT group were cured compared to 87% in the TVT-O group. Objectively, on pad test testing, cure rates were 92% and 89% respectively. There were no differences in voiding difficulties and length of stay although there were more bladder perforations in the TVT group; 4% versus

Sheath Bladder Vagina

Buffer anterior to rectus sheath

Rectus sheath

Suture between buffers

Symphysis pubis

Buffer Vagina

Rectum

Buffer anterior to rectus sheath

Rectus sheath

Suture between buffers

Symphysis pubis

Buffer Vagina

Rectum

Uterine Sling Tvt

Bladder

Uterus

Bladder

Uterus

Fig. 49.26 Stamey procedure.

none in the TVT-O group. A further multicentre prospective randomized trial comparing TVT and TVT-O has also recently been reported from Finland in 267 women complaining of stress urinary incontinence [143]. Objective cure rates at 9 weeks were 98.5% in the TVT group and 95.4% in the TVT-O group (p = 0.1362). Whilst complication rates were low and similar in both arms of the study there was a higher incidence of groin pain in the TVT-O group (21 versus 2; p = 0.0001).

bladder neck suspension procedures

Endoscopically guided bladder neck suspensions [144-146] are simple to perform but may be less effective than open suprapubic procedures and are now seldom used. In all these operations a long needle is used to insert a loop of nylon on each side of the bladder neck; this is tied over the rectus sheath to elevate the urethrovesical junction (Fig. 49.26). Cystoscopy is employed to ensure accurate placement of the sutures and to detect any damage to the bladder caused by the needle or the suture. In the Stamey procedure buffers are used to avoid the sutures cutting through the tissues, and in the Raz procedure a helical suture of Prolene is inserted deep into the endopelvic fascia lateral to the bladder neck to avoid cutting through. The main problem with all these operations is that they rely on two sutures and these may break or pull through the tissues. However, endoscopically guided bladder neck suspensions are quick and easy to perform. They can be carried out under regional blockade and postoperative recovery is fast. Temporary voiding difficulties are common after long needle suspensions but these usually resolve and there are few other complications.

urethral bulking agents

Urethral bulking agents are a minimally invasive surgical procedure for the treatment of urodynamic stress incontinence and may be useful in the elderly and those women who have undergone previous operations and have a fixed, scarred fibrosed urethra.

Although the actual substance which is injected may differ the principle is the same. It is injected either peri-urethrally or transurethrally on either side of the bladder neck under cystoscopic control and is intended to 'bulk' the bladder neck, in order to stop premature bladder neck opening, without causing out-flow obstruction. They may be performed under local, regional or general anaesthesia. There are now several different products available (Table 49.12). The use of minimally invasive implantation systems (Fig. 49.27) has also allowed some of these procedures to be performed in the office setting without the need for cystoscopy.

In the first reported series 81% of 68 women were dry following two injections with collagen [147]. There have been longer term follow-up studies most of which give a less than 50% objective cure rate at 2 years but a subjective improvement rate of about 70% [148-150]. Macroplastique has recently been compared to Contigen in a recent North American study of 248 women with urodynamic stress incontinence. Outcome was assessed objectively using

Table 49.12 Urethral bulking agents

Urethral bulking agent

Application technique

Gluteraldehyde cross linked bovine collagen (Contigen)

Polydimethylsiloxane (Macroplastique)

Pyrolytic carbon coated zirconium oxide beads in ß glucan gel (Durasphere)

Ethylene vinyl co-polymer in dimethyl sulfoxide (DMSO) gel (Tegress, Uryx)

Calcium hydroxylapatite in carboxymethylcellulose gel (Coaptite)

Copolymer of hyaluronic acid and dextranomer (Zuidex)

Polyacrylamide hydrogel (Bulkamid)

Cystoscopic Cystoscopic

MIS implantation system Cystoscopic

Cystoscopic

Cystoscopic

Cystoscopic Implacer system Cystoscopic

Urethral Bulking Procedure
Fig. 49.27 Macroplastique urethral bulking agent and implantation device.

pad tests and subjectively at 12 months. Overall objective cure and improvement rates favoured Macroplastique over Contigen (74% versus 65%; p = 0.13). Whilst this difference was not significant subjective cure rates were higher in the Macroplastique group (41% versus 29%; p = 0.07) [151]. A 12 month open label European study of 142 women with urodynamic stress incontinence treated with Zuidex has reported cure and improvement rates of 78% at 12 weeks and 77% at 12 months [152].

Whilst success rates with urethral bulking agents are generally lower than those with conventional continence surgery they are minimally invasive and have lower complication rates meaning that they remain a useful alternative in selected women.

artificial urinary sphincter

An artificial sphincter is an ingenious device which may be employed when conventional surgery fails [153]. This is implantable and consists of a fluid-filled inflatable cuff which is surgically placed around the bladder neck. A reservoir, containing fluid, is sited in the peritoneal cavity and a small finger-operated pump is situated in the left labium majus. The three major components are connected via a control valve. Under normal circumstances the cuff is inflated, thus obstructing the urethra. When voiding is desired the pump is utilized to empty the fluid in the cuff back into the balloon reservoir so that voiding may occur. The cuff then gradually refills over the next few minutes. Artificial sphincters are associated with many problems. They are expensive, the surgery required to insert them is complicated and the tissues around the bladder neck following previous failed operations may be unsuitable for the implantation of the cuff. In addition, mechanical failure may occur, necessitating further surgery. However, there is a place for these devices and their technology is likely to improve in the future.

There are a few unfortunate women in whom neither conventional nor even the newer forms of incontinence surgery produce an effective cure. For them a urinary diversion may be a more satisfactory long-term solution than the continued use of incontinence aids.

It is important to remember that the first operation for stress incontinence is the most likely to succeed. Most suprapubic operations in current use produce a cure rate in excess of 85-90% in patients undergoing their first operation for correctly diagnosed urodynamic stress incontinence. The Burch type of colposuspension has long been recognized as the 'best' first operation although tension free vaginal tape (TVT) is now the most commonly performed continence procedure. Whilst transobturator tapes are becoming increasingly popular at present there is little long term data to support their use over the retropubic approach. Subsequent surgery may have to be performed on a vagina which is less mobile and where there is fibrosis of the urethra. In such cases, a urethral bulking agent may be easier to perform and more effective. Ultimately it is important that the operative procedure performed is tailored to suit the needs of the individual.

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