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Surgery for Urinary Incontinence in Women

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Surgery for Urinary Incontinence in Women Committee 14 Surgery for Urinary Incontinence in Women Chair A.R.B. SMITH (U.K) Members R. DMOCHOWSKI (USA), P. H ILTON (U.K), E. ROVNER (USA), C.G. NILSSON (Fin) Consultants F.M. REID (U.K), D. CHANG (USA) 1191 CONTENTS INTRODUCTION VI. COMPLICATIONS OF SURGERY FOR DETRUSOR OVERACTIVITY I. SURGERY FOR STRESS INCONTINENCE VII. NEUROMODULATION VIII. URETHRAL DIVERTICULUM II. CONFOUNDING VARIABLES IX. NON-OBSTETRIC URINARY III. STRESS INCONTINENCE WITH FISTULAE PROLAPSE X. OUTCOME MEASURES IV. COMPLICATIONS OF SURGERY FOR STRESS INCONTINENCE IX. ARTIFICIAL URINARY SPHINCTER IN WOMEN V. SURGERY FOR DETRUSOR OVERACTIVITY REFERENCES 1192 Surgery for Urinary Incontinence in Women A.R.B. SMITH R. DMOCHOWSKI, P. HILTON, E. ROVNER, C.G. NILSSON, F.M. REID, D. CHANG literature available at the time (Black & Downs, 1996, INTRODUCTION Downs & Black, 1996) [2,3]. In particular they highlighted the difficulties posed by case definition Surgeons have been criticised for the lack of rigour and the uniformity of surgical technique both between with which they have analysed their results. This and within surgical teams, the problem of variations chapter highlights the progress made, particularly in in outcome measures used, the handling of con- surgery for stress incontinence where more founding variables, the generalisability or external randomised controlled trials have been reported, and validity of the results, and the lack of statistical power illustrates areas where more studies are needed. The in most studies. Most systematic reviews published section on outcome measures illustrates that whilst since on the topic of surgery for incontinence in general the measurement of subjective and objective outcome or relating to individual surgical procedures have may clarify the value of an operation some standa- made similar comments regarding the quality of rdisation of outcome measures is required in order to available evidence. Hence recommendations must meaningfully compare different procedures. be made not only on the amount of evidence available, but on the quality of that evidence. Several systems for grading the quality of studies have been proposed, I. SURGERY FOR STRESS including that initially presented by Black and Downs INCONTINENCE (Black & Downs, 1996, Downs & Black, 1996) [2,3], and that proposed by the GRADE group (Grading of Recommendations Assessment, Development and 1. PROCEDURES EXCLUDING MID-URETHRAL Evaluation) in their publications (Atkins et al., 2004a, TAPES Atkins et al., 2004b, Atkins et al., 2005) [4,5,6] and on The practice of surgical treatment for stress urinary their website, http://www.gradeworkinggroup.org. A incontinence has changed dramatically over the last recent series of articles in the BMJ explain the GRADE decade; the number of procedures undertaken system in more detail (Guyatt et al., 2008a, Guyatt et appears to be increasing, and the shift in relative al., 2008b, Guyatt et al., 2008c) [7,8,9]. numbers of different procedures has been remarkable. The duration of follow-up is another factor affecting the In England between 1997-‘98 and 2005-‘06 the annual validity of comparison between studies of efficacy number of operations undertaken for stress urinary and safety. In the first edition of this consultation, it was incontinence (SUI) increased by 28%, despite over suggested that short term surgical follow-up should 90% reduction in the numbers of colposuspension be considered as being up to 3 months, medium term and needle suspension procedures, and 50% from 3 to 12 months, and long term over 12 months reduction in bladder neck buttress, sling and urethral (Mattiasson et al., 1999) [10]. There are occasions bulking procedures. The increase was entirely due when case reports or short-term trial follow up and the to the rapid dissemination of the Tension-free Vaginal early presentation of outcomes may be not only Tape (Gynecare®, Ethicon, Somerville, NJ) in 1998, appropriate but also indeed mandatory. If serious and similar minimally invasive synthetic sub urethral unexpected adverse events come to light during early sling procedures subsequently (Hilton, 2008) [1] experience with procedures, colleagues and patients must be made aware. Where significant differences Whilst these trends may be in line with currently in efficacy or safety outcomes become apparent before available evidence, other changes in practice seem the end of a study, it may be ethically unacceptable to proceeding in advance of high quality evidence; to continue randomisation. It is unlikely however that the drivers behind such changes in practice have these factors are at play in the majority of studies of recently been reviewed (Hilton, 2008)[1]. less than a year follow-up. In a recent review on long- In their systematic review published in 1996, Black and term studies of pelvic floor dysfunction Hilton found Downs drew attention to the deficiencies of the that of 127 papers published in the last 25 years on 1193 incontinence or pelvic organ prolapse (POP) which transurethra$ or trans urethra$ or pubovescial$ or included the phrase ‘long term’ in their title or abstract, pubo vesical$ or retropubic$ or retro pubic$ or follow-up periods ranged from 1 to 14 years, with a suprapubic$ or supra pubic$ or pubovagina$ or pubo- mean of 59.5 months in those investigating surgical vagina$ or transvagina$ or intravagina$ or lyodura$) treatments (Hilton, 2008) [1]. Whilst highlighting some adj3 (sling$ or mesh$ or implant$)); bologna$; of the difficulties inherent both in undertaking and ingelman sundberg$; “PROSTHESES AND interpreting long-term studies, he argued for more IMPLANTS”/; INJECTIONS/; ((urethra$ or suburethra$ long-term studies of high quality, and for a change in or midurethra$ or mid urethra$ or transurethra$ or definition of ‘long-term’ to imply outcome at 5 years trans urethra$ or periurethra$ or peri urethra$ or or more (Hilton, 2008) [1]. endourethra$ or endo urethra$) adj3 (inject$ or agent$ a) Search strategy or bulk$)); injectable$; (injection$ adj3 therap$); (bulk$ adj3 agent$); contigen; COLLAGEN/; macroplastique$; This section is based on electronic searches of exp SILICONES/; microparticulate$; HYALURONIC Medline, EMBASE, CINHAL, the Cochrane database ACID/; hyaluronan therap$; act balloon$; CARBON/; of systematic reviews, and the NICE website carbon particle$; POLYTETRAFLUORETHYLENE/; (www.nice.org.uk) references included in identified BIOCOMPATIBLE MATERIALS; URINARY reviews were evaluated separately. Hand searching SPHINCTER, ARTIFICIAL/; ((artificial$ or prosthe$) of recent (Jan-Apr 2008) issues of American, European adj3 (urinary or genitourinary or urethra$ or bladder$) and British journals in urology, gynaecology and adj3 sphincter$); limit to humans; limit to female. urogynaecology was undertaken, to capture recent publications not yet included in the online databases. Relatively little high-level evidence has been published ICS, IUGA, AUA and AUGS conference proceedings on the basis of new research since the last for 2007 were also reviewed. It was assumed that consultation; where available, level 1 and 2 evidence trials presented earlier than this would be in press if has been included in this update. Systematic reviews they were of sufficient quality and maturity to justify had already been published by the Cochrane inclusion; hence older abstracts have not been Collaboration (Moehrer et al., 2000, Bezerra et al., considered here. A total of 5331 references were 2001, Glazener & Cooper, 2001, Pickard et al., 2003, identified; excluding duplicates, there were 3650 Glazener & Cooper, 2004) [11-15], and others have unique references. Of these 762 were of relevance to been developed or updated since (Bezerra et al., this review of non-tape procedures. Search terms 2005, Lapitan et al., 2005, Dean et al., 2006a, Keegan used included the following: et al., 2007) [16-19]. The National Institute for Health URINARY INCONTINENCE; URINARY INCON- and Clinical Excellence (NICE) in England has TINENCE, STRESS/; ((stress$ or mix$ or urg$ or published a clinical guideline on all aspects of urinary urine$) adj3 incontinen$); SURGICAL PROCE- incontinence in women, including sections on surgical DURES, OPERATIVE/; SURGICAL PROCEDURES, treatment (National Institute for Health & Clinical MINIMALLY INVASIVE/; UROGENITAL SURGICAL Excellence, 2006b), based on systematic reviews PROCEDURES/; GYNECOLOGIC SURGICAL PRO- undertaken by the National Collaborating Centre for CEDURES/; UROLOGIC SURGICAL PROCEDURES; Women’s and Children’s Health (National Collaborating UROGENITAL SYSTEM/su [Surgery]; URINARY Centre for Women’s & Children’s Health, 2006). NICE TRACT/su [Surgery]; URETHRA/su [Surgery]; has also published guidance on a number of individual VAGINA/su [Surgery]; BLADDER/su [Surgery]; procedures through its Interventional Procedures LIGAMENTS/su [Surgery]; ((urethra$ or vagina$ or Programme (National Institute for Health & Clinical bladder$) adj surger$); (colposuspension$ or colpo Excellence, 2003, 2005a, b, 2006a). http://www. suspension$); vesicosuspension$; urethrosu- nice.org.uk spension$; ((vesicourethra$ or urethrovesica$) adj3 b) Anterior colporrhaphy. suspens$); colpourethrosuspension$; (corner$ adj3 suspension$); (urethropex$ or urethrocystopex$ or The term ‘anterior colporrhaphy’ tends to be used cystourethropex$ or urethrocervicopex$); (bladder$ generically to describe procedures for both anterior adj3 buttress$); colpofixation$; burch$; (marshall$ or vaginal wall prolapse and for SUI. When used to treat marchetti$
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