Surgical Management of Stress Urinary Incontinence

Surgical Management of Stress Urinary Incontinence

European Urology European Urology 47 (2005) 648–652 Surgical Management of Stress Urinary Incontinence A Questionnaire Based Survey Swati Jha*, A.S...

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European Urology

European Urology 47 (2005) 648–652

Surgical Management of Stress Urinary Incontinence A Questionnaire Based Survey Swati Jha*, A.S. Arunkalaivanan, James Davis Department of Urogynaecology, City Hospital, Dudley Road, Birmingham, B18 7QH, UK Accepted 21 December 2004 Available online 8 January 2005

Abstract Objectives: To determine the trends in the surgical management of urinary stress incontinence amongst members of the International Urogynaecology Association (IUGA). Design: Postal Questionnaire Survey. Methods: 530 members of the International Urogynaecology association were sent a postal questionnaire regarding their practice in the surgical management of urinary stress incontinence. We also collected data on the demographic profile of members and the preferred primary and secondary continence procedures. Outcome: Consensus in the surgical management of urinary stress incontinence amongst members of the IUGA. Results: Five hundred and thirty questionnaires were sent to IUGA members worldwide. Two hundred and seventeen questionnaires were received of which fifteen were from physiotherapists, so were excluded from our analysis. The overall response rate was 41%, and the useable response rate was 38%. Of the total results analysed (two hundred and two), one hundred and twelve (54%) were from teaching hospital, sixty-two (31%) were from district general hospitals and twenty-eight (14%) were from members in private practice. The preferred primary continence procedure was Tension Free Vaginal Tape (TVT) in one hundred and thirty four (68%) respondents. The preferred secondary continence procedure was colposuspension or Trans obturator tape in twenty-six respondents each (13%). Conclusions: Almost all respondents (97.1%) were skilled at performing either TVT or colposuspension, which have been identified as the preferred methods of surgical management by the NICE (National Institute of Clinical Excellence, UK). Although colposuspension has been identified as the gold standard surgical procedure in the management of stress incontinence, 16% of respondents were not performing colposuspension. There appears to be little evidence base to the surgical techniques in the management of stress urinary continence. # 2004 Elsevier B.V. All rights reserved. Keywords: Urinary stress incontinence; TVT; Colposuspension; Urethral bulking agents

1. Introduction The prevalence of urinary incontinence has been identified in approximately 14% of women above 30 years of age [1]. With an increase in the postmenopausal female population there is a growing demand for improved management of pelvic-floor dysfunction. * Corresponding author. Present address: 123, Lodge Hill Road, Selly Oak, Birmingham, B29 6NL, UK. Tel. +44 121 243 9095. E-mail address: [email protected] (S. Jha).

This has led to the establishment of urogynaecology as a separate subspecialty of gynaecology. The management of urodynamic stress incontinence (USI) has seen considerable progress since the days when Poussan advocated advancement of the urethra in 1892 [2]. However there continues to be considerable disparity in the surgical management of USI. The purpose of our study was to establish a consensus in the surgical management of USI amongst members of the International Urogynaecology Association (IUGA) worldwide.

0302-2838/$ – see front matter # 2004 Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2004.12.017

S. Jha et al. / European Urology 47 (2005) 648–652

2. Methods The questionnaire was developed by asking urogynaecology practitioners what they felt were contentious issues in the surgical management of USI. This three-page questionnaire (Appendix A) was sent to the 530 members listed in the IUGA directory 2004. The addresses and email addresses were obtained from the directory. A covering letter describing the objectives of the study accompanied the questionnaire. After one month reminders were sent to the members via email. Those who had not completed the initial questionnaire were again asked to complete it. Respondents were asked to give the single most appropriate match to answer the questions. A broad range of questions relating to the different surgical methods in common use in the treatment of USI were asked. We also obtained information regarding the number of continence procedures carried out by IUGA members monthly, the number of years of experience they had and whether they routinely carried out urodynamics preoperatively or not. They were also asked demographic details and the type of institute they were working at. Respondents were asked what they felt was the best method of training for incontinence procedures, and how they preferred to respond to questionnaire surveys.

3. Results A total of 217 questionnaires were received i.e. 41% response rate. Of these only 202 were used for analysis, as 15 were from physiotherapists who were not performing any surgery. This gave us a useable response rate of 38%. Though we asked respondents to give the single most appropriate answer this was not strictly adhered to. In several questionnaires more than one option was chosen. In these cases each response chosen was analysed. Of the 202 responses obtained 60% were from teaching hospitals, 31% from district general hospitals and 20% from members in private practice. Most of the respondents were from Europe and accounted for 60% of the total responses received (Table 1). 60% of the respondents were between the age of 30 and 50. Only 43% were performing more than 10 incontinence procedures in a month whereas almost an equal number (40%) were performing between 5 to10 procedures in a month. Table 1 Demography of respondents Continent

% Response

Europe Asia Australia & New Zealand Africa Latin America North America

57.9 7.9 12.4 1 1.5 19.3

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When asked if urodynamics was routinely being performed prior to incontinence surgery, 91% admitted to routine urodynamics prior to surgery. However 9% accepted they were not routinely doing urodynamics prior to surgery. The reasons given for not performing urodynamics included the test being expensive, the test being unnecessary, and in patients with symptoms of mixed incontinence. The preferred primary continence procedure (Table 2) was TVT (68%). This was followed by TOT (trans-obturator tape) and colposuspension in 13% each. Anterior and posterior repair was still the primary continence procedure of choice in 3%. Other less common procedures of first choice included IVS Tape (TYCO) and TFS. A small proportion varied their primary procedure depending on the patient’s circumstances (3%). It was interesting to find that the urologists had similar preferences to the remaining respondents. The most popular procedure amongst the urologists was TVT (73%) followed by colposuspension (13%). However none of the urologists performed anterior repair as a primary continence procedure. The preferred secondary continence procedure (Table 2) was TVT in a majority (37%) followed a close second by colposuspension (34%). Urethral bulking agents (8%), TOT (7%) and anterior repair with bladder buttress (4%) were other secondary procedures of choice. Pubovaginal slings, using autologous fascia and cadaveric fascia, proposed by McGuire [3] accounted for 10% of the preferred secondary continence procedures. When questioned about the methods of training, opinion was divided. Most members felt the best method was hands on training on patients (65%). A smaller proportion felt cadaveric workshops were the best method of training (25%). Other proposed methods included video link workshops, training on animal models and training on inanimate models. With regard to colposuspension we enquired what the preferred suture material was, the type of catheter used postoperatively, how long catheters were left in situ and what proportion of members were performing colposuspension laparoscopically. 83% of respondents were performing colposuspension. Ethibond (nonabsorbable polyester suture) was the suture of choice in the majority (55%). 16% used vicryl as their preferred suture material and 14% PDS. Other sutures used included gortex, prolene, nylon and ticron. Almost equal numbers of respondents used either a suprapubic (42%) or urethral catheter (41%), 15% used both and 2% did not use a catheter following a colposuspension. The majority of respondents removed the catheter by 48 hours (73%) whereas 27% left the catheter in situ

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Table 2 Preferred primary and secondary continence procedures

4. Discussion

Procedure

Preferred primary procedure (%)

Preferred secondary procedure (%)

TVT Colposuspension TOT Anterior repair with bladder buttress Urethral bulking agents Others (depending on patient circumstances, pubovaginal sling, cadaveric fascia sling, TVS)

68.1 13.2 13.2 2.5 – 3

37.3 34.2 6.2 4.1 7.8 10.4

for longer. Only 20% of members performing colposuspension were skilled at doing the procedure laparoscopically. The questions relating to TVT included the type of anaesthetic, whether a post procedure cough test was performed or not, whether catheters were used postoperatively or not and how long they were left in situ. We also enquired if members were routinely auditing their success rates or not. 96% of respondents were performing TVT. The majority of the respondents were using regional anaesthesia (45%) for performing TVT followed by local anaesthesia in 33%. General anaesthesia was being used only by 21%. A post procedure cough test was done in 60% cases. Catheters were being used postoperatively in 58%, and, in a majority (83%) were being left for 24 hours or less. The post-operative volume deemed appropriate for discharge was 100 millilitres in the majority (68%). On the other hand, 20% used 150 mls as their cut off and 3% even used 200 mls as the cut off. Though 93% of respondents were auditing their success rates, 7% were not. The use of urethral bulking agents was the third variety of surgery we enquired about. We asked respondents what the favoured bulking agent was, the group of women in whom they would use bulking agents, whether the procedure was performed under cystoscopic guidance and whether it was injected periurethral or transurethral. 62% of respondents were using urethral bulking agents. Macroplastique was the most commonly used (36%) followed by bovine collagen in 28% and Zuidex in 20%. Patient selection appeared to have no specific strong criteria, ranging from patients unfit for other surgery, those with ISD (intrinsic sphincter deficiency), failed continence procedure and those willing and able to pay. 75% of those respondents using UBA were doing so under cystoscopic guidance. The preferred method of injecting the bulking agents was transurethral in 75%.

It is evident that there is considerable variation in surgical practice in the management of USI. In the absence of an evidence-based approach to most aspects of the surgical management, the technique and methods are guided predominantly by the surgeons’ personal preference. Although the useable response rate was only 38%, there were sufficient replies to make this a valid consensus. The validity would have been greater however, if we had received a better response. The poor response may be explained by ‘questionnaire fatigue’, as described in the comments section by one of the respondents. This member commented he received so many questionnaires, that it was becoming cumbersome to answer them all. Other methods of collecting data using sources such as billing or hospital data are an alternative option. Since use of hospital data would be less reliant on respondents, the results would be more representative of true practice. The predominant surgical procedure of choice is now TVT. This has replaced colposuspension as the primary continence surgery of choice. Since the publication of the recent NICE [4] (National Institute of Clinical Excellence) guidelines on the surgical management of USI, both TVT and colposuspension have been identified as the gold standard surgical procedures in the management of stress incontinence [5]. However as TVT is an easier procedure associated with less morbidity than colposuspension, so is fast becoming more popular. TVT was also more likely to be costeffective compared to colposuspension as long as the differential inpatient length of stay for women in the TVT group was no more than one day higher than for those who underwent Colposuspension [6]. It was surprising to note that anterior repairs were still the procedure of choice in a small proportion despite the fact that it’s limitations as a primary continence operation was recognised as early as 1954 by Bailey [7]. This probably has to do with training implications. The role of urethral bulking agents as a first line treatment is virtually nonexistent, but it has a small albeit limited role as a secondary continence procedure. Colposuspension was first described by Burch [8] in 1961. Though the suture used in the initial series described by Burch was chromic catgut, our survey showed that the most commonly used suture material was Ethibond. This is not surprising considering chromic catgut is now virtually obsolete in practice. A search of literature was unable to establish the evidence base to the use of Ethibond as the most commonly used suture material however. Suprapubic catheterisation

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has been the recommended mode of bladder drainage following the procedure [9] till date. Our survey showed that almost equal numbers of respondents preferred suprapubic and urethral catheterisation. In a recent randomised study [10] looking at the need for post operative catheterisation, it was concluded that an indwelling catheter had no statistically significant difference on the incidence of voiding dysfunction in the post operative period. According to this same study however, postoperative catheterisation did significantly increase the inpatient hospital stay of patients. Laparoscopic colposuspension was performed by only 20% of respondents performing open Burch. Patient reported failure rates showed no significant difference between open and laparoscopic retropubic colposuspension, however, its relative safety and effectiveness is not known yet [5]. In the original description of TVT by Ulmsten et al, local anaesthetic was routinely used as the anaesthetic of choice. In our survey only 33% were using local anaesthesia, with the remaining respondents using either regional or general anaesthesia. However the efficacy of the procedure does not appear to be influenced by the type of anaesthesia [11]. A post procedure cough test continues to be done by the majority (60%) of respondents. The utility of this has not been established however [12]. Postoperative catheters are also used by just over half the respon-

Appendix A. Questionnaire for Surgical Management of Stress Urinary Incontinence Please mark the most appropriate answer (one only) with an ‘X’

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dents (58%) but most respondents use it for less than 24 hours. This is possibly explained on the basis of the fact that urinary retention is a frequent immediate postoperative complication of TVT, but tends to be self- limiting and rarely persists beyond 24–48 hours [13]. Injectable agents have a lower success rate than other procedures, however in view of the low morbidity may have a place when other procedures have failed [14]. A comparison of periurethral and stransurethral methods of delivery of the bulking agent found similar outcome but a higher rate of early complications in the periurethral group [15]. There appears to be no evidence base to the preference of one bulking agent over another. One randomised trial [16] compared the macroplastique (silicone) to permacol (porcine dermal implant). This study found that Permacol injection appears to have a higher cure rate for urodynamic stress incontinence than Macroplastique and these results persist until the follow-up period of 6 months. As our understanding and knowledge of urogynaecology enhances, more of what we do is becoming evidence based. However there are still major caveats in most aspects of the surgical management of USI. Much research and work is still required before there is a strong evidence base to our surgical management and approach to USI.

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References [1] Health Survey Questionnaire: Market and Opinion research International (MORI).1990;95. [2] Poussan. Arch Clin Bord 1892. No 1. [3] McGuire EJ, Lytton B. Pubovaginal sling procedure for stress incontinence. J Urol 1978;119:82–4. [4] Great Britain. National Institute for Clinical Excellence. Technology Appraisal No. 56. Guidance on the use of tension-free vaginal tape (Gynecare TVT) for stress incontinence. February 2003. [5] Lapitan MC, Cody DJ, Grant AM. Open retropubic colposuspension for urinary incontinence in women. The Cochrane Database of Systematic Reviews 2003, Issue 1. Art. No. CD002912. doi:10.1002/ 14651858.CD002912. [6] Manca A, Sculpher MJ, Ward K, Hilton P. A cost-utility analysis of tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence. Br J Obstet Gynaecol 2003;110(3):255–62. [7] Bailey KV. A clinical investigation into uterine prolapse with stress incontinence. Treatment by modified Manchester colporrhaphy. J Obstet Gynaecol Br Emp 1954;61:291–8. [8] Burch JC. Coopers ligament urethrovesical suspension for stress incontinence. 3 years experience-results, complications, technique. Am J Obstet Gynaecol 1968;100:764–74. [9] Stanton SL, Williams JE, Ritchie B. The colposuspension operation for urinary incontinence. Br J Obstet Gynaecol 1976;83: 890–5.

[10] Sun MJ, Chang S-Y, et al. Is an indwelling catheter necessary for bladder drainage after modified Burch colposuspension? Int Urogynecol J Pelvic Floor Dysfunct 2004;15(3):203–7. [11] Adamiak A, Milart P, Skorupski P, Kuchnicka K, Nestorowicz A, Jakowicki J, et al. The efficacy and safety of the tension-free vaginal tape procedure do not depend on the method of analgesia. Eur Urol 2002;42(1):29–33. [12] Low SJ, Smith KM, Holt EM. Tension free vaginal tape: is the intraoperative cough test necessary? Int Urogynecol J Pelvic Floor Dysfunct 2004;15(5):328–30. [13] Abouassaly R, Steinberg JR, Lemieux M, Marois C, Gilchrist LI, Bourque JL, et al. Complications of tension-free vaginal tape surgery: a multi-institutional review. BJU Int 2004;94(1):110–3. [14] http://www.rcog.org.uk/resources/Public/Urodynamic_stress_incontinence_No35. [15] Pickard R, Reaper J, Wyness L, Cody DJ, McClinton S, N’Dow J, Periurethral injection therapy for urinary incontinence in women. The Cochrane Database of Systematic Reviews 2003, Issue 2. Art No.: CD003881. doi:10.1002/14651858.CD003881. [16] Bano F, Barrington JW, Dyer R. Comparison between porcine dermal implant (Permacol) and silicone injection (Macroplastique) for urodynamic stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2004; Sep 18 (Epub ahead of print).