Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women(review)

Transcription

1 Cochrane Database of Systematic Reviews Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women(review) Bakali E, Buckley BS, Hilton P, Tincello DG Bakali E, Buckley BS, Hilton P, Tincello DG. Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD DOI: / CD pub2. Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women(review) Copyright 2013 The Cochrane Collaboration. Published by John Wiley& Sons, Ltd.

2 T A B L E O F C O N T E N T S HEADER ABSTRACT PLAIN LANGUAGE SUMMARY BACKGROUND OBJECTIVES METHODS RESULTS Figure DISCUSSION AUTHORS CONCLUSIONS ACKNOWLEDGEMENTS REFERENCES CHARACTERISTICS OF STUDIES DATA AND ANALYSES APPENDICES WHAT S NEW CONTRIBUTIONS OF AUTHORS DECLARATIONS OF INTEREST SOURCES OF SUPPORT DIFFERENCES BETWEEN PROTOCOL AND REVIEW INDEX TERMS i

3 [Intervention Review] Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women Evangelia Bakali 1, Brian S Buckley 2, Paul Hilton 3, Douglas G Tincello 4 1 Obstetrics and Gynaecology, Leicester General Hospital, Leicester, UK. 2 Department of General Practice, National University of Ireland, Galway, Ireland. 3 Directorate of Women s Services, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK. 4 Reproductive Sciences Sections, Cancer Studies & Molecular Medicine, University of Leicester, Leicester, UK Contact address: Douglas G Tincello, Reproductive Sciences Sections, Cancer Studies & Molecular Medicine, University of Leicester, RKB, Leicester Royal Infirmary, Leicester, Leicestershire, LE2 7LX, UK. dgt4@le.ac.uk. Editorial group: Cochrane Incontinence Group. Publication status and date: New, published in Issue 2, Review content assessed as up-to-date: 18 December Citation: Bakali E, Buckley BS, Hilton P, Tincello DG. Treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD DOI: / CD pub2. Background A B S T R A C T Surgery is a common treatment modality for stress urinary incontinence (SUI), usually offered for women who fail conservative treatments. Suburethral tapes have superseded colposuspension because cure rates are comparable and recovery time reduced. However, some women will not be cured after suburethral tape surgery, and currently there is no consensus on how to manage these women. Objectives To obtain and examine evidence supporting different management strategies for recurrent/persistent stress urinary incontinence (SUI) in women after failed suburethral tape surgery. Search methods We searched the Cochrane Incontinence Group Specialised Register of controlled trials (searched 18 December 2012), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and PreMEDLINE; and handsearched journals and conference proceedings, and the reference lists of included studies and previous Cochrane reviews for randomised or quasi-randomised studies treating patients with recurrent incontinence, either as the sole population or a subset. Conservative, medical and surgical treatments were included. Selection criteria We included randomised and quasi-randomised controlled trials in women who had recurrent urinary incontinence after previous minimally invasive suburethral tape surgery. Data collection and analysis Abstracts of identified studies were checked by two authors to confirm eligibility. Full text reports of relevant studies were obtained, and authors were contacted directly where necessary. Outcome data were extracted onto a standard proforma and processed according to the methods in the Cochrane Handbook for Systematic Reviews of Interventions. 1

4 Main results Twelve studies were identified, but all were excluded because they did not meet the eligibility criteria. Six were randomised controlled trials (RCTs) but were not eligible because the previous incontinence surgery was not a suburethral tape. A subset of one RCT may have been eligible for inclusion because some of the women were having repeat surgery, but we were unable to obtain from the authors the data according to primary surgery for this cohort. Authors conclusions There were no data to recommend or refute any of the different management strategies for recurrent or persistent stress incontinence after failed suburethral tape surgery. Evidence is urgently required to address this deficiency, ideally from RCTs. P L A I N L A N G U A G E S U M M A R Y Treatment of recurrent stress urinary incontinence in women after a failed suburethral tape operation Stress urinary incontinence (SUI) is loss of urine when a person coughs or exercises. Damage to the pelvic floor muscles and injuries to the nerves during childbirth may lead to SUI. Simple treatments, such as exercising the muscles in the pelvic floor or drugs (medication), may be tried at first. If these methods have not worked, surgery is often performed. This usually involves placing a tape made from polypropylene (a synthetic material, like nylon, that is used in some surgical stitches and other medical devices) underneath the neck of the bladder. This operation is very successful but not all women will be cured after a first tape surgery, and there is currently no agreement among experts on how to treat women with persistent or recurrent problems. This review set out to find evidence for different treatments, but it did not identify any studies which provided answers. High quality randomised clinical trials are urgently needed to answer this question. B A C K G R O U N D Description of the condition Stress urinary incontinence (SUI) is defined as a complaint of involuntary loss of urine on effort or physical exertion (for example sporting activities), or on sneezing or coughing (Haylen 2010). It can be a debilitating condition for women, severely affecting their quality of life (Margalith 2004). Surgery is a common treatment modality that is usually offered for women who fail conservative treatments. Description of the intervention Currently the most common surgical option for SUI is the tension free vaginal tape (TVT) (Hilton 2008). This has superseded colposuspension as the gold standard treatment in recent years due to comparable cure rates and more rapid return to normal activity. Cure rates for incontinence after TVT are comparable to colposuspension (Ward 2008). More recently, alternative suburethral tapes have been developed, including the trans-obturator tapes (inserted via the inside out or outside in routes) and various single incision tapes. Cure rates for these other tapes appear comparable although robust comparative studies for the newer devices are lacking (Novara 2010). However, some patients will not be cured after suburethral tape surgery, and currently there is no consensus on how to manage these patients. This constitutes a major problem not only for the patient but also for the clinician who is faced with choosing a second surgical procedure with the best possible long term success rate. Furthermore, there is no consensus about whether the previously inserted tape should be excised or if a second tape should simply be placed over the existing tape. The decision whether to use a tape inserted via a different route (retropubic versus trans-obturator versus single incision) also has not been addressed. Recurrent SUI after a TVT procedure is reported to be from 2% to 16% (Merlin 2001). Comparably, recurrence after two years following the Burch colposuspension has been reported as about 10% (Alcalay 1995; Auwad 2006; Monga 1994; Ward 2008). Despite the recurrence of urinary incontinence, sling procedures seem to be the treatment of choice for managing recurrent SUI (McGuire 1992). A preliminary study using a pubofascial anchor 2

5 sling procedure for recurrent SUI conducted by Kane et al (Kane 1999) found that all 13 patients claimed subjective cure of urinary continence and 12 of the 13 were objectively cured. Similar results were also published by Barrington 1998 using a modified rectus fascial sling. Breen 1997, in a study of 60 participants, reported the use of a suburethral fascia lata sling as an effective method of treatment of recurrent SUI with a 90% cure rate. A small randomised controlled study by Enzelsberger 1996 comparing the Lyodura sling and Burch colposuspension at 32 to 48 months follow up for repair of unsuccessful incontinence surgery found a cure rate of 86% for the Burch and 92% for the sling. They suggested that sling surgery should be used only in certain cases due to the higher rate of complications, and a posterior vaginal repair should be performed after the modified Burch colposuspension. How the intervention might work Further surgery following failed continence surgery of any tape has a short term subjective cure rate of 80% and an objective cure rate of about 75% (Cardozo 1999; Maher 1999). Various factors have been associated with failure of surgery for SUI, such as a preoperative weight of greater than 80 kg (Alcalay 1995), low preoperative urethral pressure, pre-operative detrusor overactivity or its development post-operatively (Stanton 1978) and intra-operative blood loss of over one litre (Alcalay 1995). Success rates vary depending on the different sling types but Jarvis 1994 suggested that long term success may be higher with the repeat Burch colposuspension. A prospective cross-sectional observational study by Thakar (Thakar 2002), evaluating secondary colposuspension for recurrent SUI, reported a 71% subjective and 80% objective cure rate with a median follow up of four years. Twenty-six patients had a colposuspension as a primary procedure and one had a sling procedure. In 2008 the James Lind Alliance, a partnership of patient and clinician groups, identified and prioritised through consensus 10 unanswered research questions thought to be of pressing clinical importance relating to the treatment of urinary incontinence (Buckley 2010). One of these treatment uncertainties was the treatment of stress urinary incontinence after failed suburethral tape surgery. The purpose of this review was to identify the existing evidence addressing this uncertainty, and identify research evidence supporting best practice for the management of recurrent urinary stress incontinence following failed suburethral tape surgery. Why it is important to do this review This review addresses a separate question to other existing reviews, although the question may be related to the existing reviews of minimally invasive slings (Ogah 2009) and single incision slings (Jeffery 2010), from which data may be extracted and analysed; data may also be extracted and analysed from other existing reviews including, for example, open retropubic colposuspension (Lapitan 2012), pelvic floor muscle training (Dumoulin 2010), periurethral injection (Kirchin 2012) and traditional sling operations (Rehman 2011). O B J E C T I V E S To obtain and examine evidence supporting different management strategies for recurrent and persistent stress urinary incontinence (SUI) in women after failed suburethral tape surgery. M E T H O D S Criteria for considering studies for this review Types of studies Randomised or quasi-randomised controlled studies comparing conservative treatment and medical or further surgical treatments, or comparing two different surgical treatments, after failed suburethral tape surgery were included. Types of participants Women of any age with persistent or recurrent SUI after any suburethral tape surgery (failed surgery). Diagnosis of SUI should normally have been confirmed by urodynamics. Women with de novo detrusor overactivity or overactive bladder (OAB) were not excluded from this review but were to be subjected to subgroup analysis if large enough numbers of patients had been identified from included studies. Recurrent incontinence after any of the suburethral tapes was included. Subgroup analyses of the outcome after specific routes of insertion would have been considered if sufficient data had been identified from the literature review (for example recurrence after retropubic versus transobturator, retropubic after single incision). Types of interventions The interventions that were compared were further surgery (including injectables), administration of medication or conservative treatment (for example pelvic floor muscle training) in patients who had failed suburethral tape surgery. Any form of previous suburethral tape was included (retropubic, transobturator (either direction), and minimally invasive). Comparisons were planned to include the following. Conservative treatment (e.g. pelvic floor muscle training or bladder retraining) versus surgical treatment (any route). 3

6 Conservative treatment versus medical treatment (e.g. duloxetine or anticholinergic medication, or both). Medical treatment versus surgical treatment (any route). Repeat suburethral sling (any type) versus any other (nontape) surgical treatment (e.g. traditional sling, colposuspension, injectables, other). One type of repeat suburethral sling versus another type of repeat suburethral sling. Repeat suburethral sling versus single incision sling. Surgery with excision of (failed) tape versus surgery without excision of tape. Where sufficient data were obtained, comparisons between pelvic floor muscle training or bladder retraining (for conservative treatment) and duloxetine or anticholinergics (for medical treatments) were undertaken. Types of outcome measures Primary outcomes The primary outcome measure was the proportion of women who had subjective (woman reported) urinary continence after intervention assessed by subjective report, urinary diary or validated incontinence questionnaires in the short term (less than 12 months) and longer term (more than 12 months). Secondary outcomes These included the following. 4. Quality of life General health status measures (e.g. Short-Form 36) (Ware 1993) Condition-specific instruments designed to assess incontinence (e.g. Bristol Female Lower Urinary Tract Symptoms questionnaire (BFLUTS) (Jackson 1996) 5. Surgical outcome measures Surgical outcomes collected included the following. Duration of operation. Length of hospital stay. Operative blood loss. Major vascular and visceral injury. Bladder, urethral and bowel perforation. Nerve damage. Peri-operative surgical complications (e.g. infection, bacteriuria, haemorrhage). 6. Adverse events Data on the following adverse events were collected, where recorded. De novo (new) urgency symptoms or urgency incontinence. De novo (new) detrusor overactivity (urodynamic diagnosis). Voiding dysfunction or difficulty passing urine after three months (with or without urodynamic confirmation). Pelvic organ prolapse (e.g. cystocele, rectocele, enterocele). Infection related to the use of synthetic mesh. Erosion to vagina. Erosion to bladder or urethra. 1. Woman s observations Women with stress incontinence not improved in the short term (less than 12 months) and longer term (more than 12 months). 2. Quantification of symptoms Incontinence episodes (from self-completed bladder chart) Pad changes (from self-reported number of pads used) Pad tests of quantified leakage (mean volume or weight of urine loss) 7. Economic measures We sought to collect any health economic data where presented. Costs of interventions. Cost effectiveness of repeat treatment. Resource implications. Search methods for identification of studies We did not impose any restrictions, for example language or publication status, on the searches detailed below. 3. Clinician s observations Objective cure rates in the short term (less than 12 months) and longer term (more than 12 months) (observed leakage during repeat urodynamics). Electronic searches Search strategies were designed in accordance with the Cochrane Incontinence Review Group methods and guidance. Relevant trials were identified by searching the Cochrane Incontinence Review 4

7 Group Specialised Register of controlled trials, which is described in the Incontinence Group s module in The Cochrane Library. The register contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PreMED- LINE, and handsearching of journals and conference proceedings. The terms that were used to search the Specialised Register are given in Appendix 1. The date of the last search was 18 December Searching other resources Reference lists from other completed reviews and the identified papers were also checked. Studies treating patients with recurrent stress urinary incontinence were included; both those studies solely recruiting recurrent cases and those where a subset of patients with recurrent stress urinary incontinence were included. Data from the recurrent cases were extracted and included in the review. Data collection and analysis Selection of studies The initial search results were scanned by two review authors to identify trials which appeared to meet the inclusion criteria. The full text reports of potentially eligible studies were accessed and read by two review authors and inclusion criteria were applied independently. Another review author acted as the arbiter and resolved any difference of opinion. Papers in languages other than English would have been assessed by native speakers for eligibility and subsequently for data extraction. Excluded studies and reasons for exclusion are detailed in the Characteristics of excluded studies table. Data extraction and management Data would have been extracted by two review authors independently using a standard form containing pre-specified outcomes. Where data from the study were not provided, the author(s) was contacted requesting further information. Included trial data were to be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Differences were resolved by discussion between the two review authors and if necessary referred to a third review author for arbitration. Assessment of risk of bias in included studies The risk of bias in eligible trials would have been assessed independently by two review authors using the Cochrane risk of bias tool. Factors that would have been considered included: quality of random sequence generation and concealment of allocation; description of drop-outs, withdrawals and missing data; blinding during intervention and at outcome assessment (where appropriate); and description of and protection against possible other sources of bias (where appropriate). Measures of treatment effect Risk ratios for dichotomous data and mean differences with 95% confidence intervals for continuous data would have been reported where relevant. Dealing with missing data Where possible, if insufficient data were included in trial reports, authors were contacted to request missing data. Assessment of heterogeneity Trial data were only to be combined if there was no clinical heterogeneity. Differences between trials would have been investigated if significant heterogeneity was found from the Chi 2 test or the I 2 statistic (Higgins 2003) or had appeared obvious from visual inspection of the results. Statistical heterogeneity would have been regarded as substantial if either the I 2 was greater than 30% or there was a low P value (less than 0.10) in the Chi 2 test for heterogeneity. Assessment of reporting biases Where appropriate, funnel plots would have been generated to assess reporting bias if enough studies were identified to allow this. Data synthesis Included data were to be processed as described in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). A fixed-effect model would have been used in data analysis unless there was evidence of marked heterogeneity, in which case a random-effects model could be used. Where quantitative data synthesis and meta-analysis were not appropriate, because of the nature of reported data or because of evident heterogeneity, a narrative review of the evidence could have been presented. Subgroup analysis and investigation of heterogeneity Where adequate data were reported, subgroup analysis would have been used to consider differences in outcomes between subgroups defined by criteria such as type of urinary incontinence (stress or urgency), race, co-morbidity, concurrent treatment for co-morbidities, different types of surgical operations and different types of anaesthetic procedures. 5

8 Sensitivity analysis If the data allowed, sensitivity analysis could have been performed to assess the effect of possible bias associated with individual trials on the outcome of the meta-analysis. R E S U L T S Description of studies See: Characteristics of excluded studies. We did not identify any relevant trial to be included in this systematic review. Results of the search In total 14 records were identified by the literature search. Twelve potentially eligible full text studies were considered, which were all excluded. Six randomised controlled trials (RCTS) (Cardozo 2002; Enzelsberger 1993; Enzelsberger 1996; Hilton 2002; Maher 2004; Wallwiener 1995) were identified but were ineligible for inclusion because the previous incontinence surgery was not a suburethral tape. One RCT (Abdel-Fattah 2011) included a subset of women having repeat suburethral tape surgery; however the authors were unwilling to share data for this subset in a manner that was appropriate for inclusion in a Cochrane review. The flow of literature through the assessment process is shown in Figure 1. 6

9 Figure 1. PRISMA study flow diagram. 7

10 Included studies No studies were included in the review. Excluded studies Twelve studies were excluded for reasons listed in the table Characteristics of excluded studies. In one excluded trial, Abdel-Fattah 2010 reported a large RCT comparing two different trans-obturator tape devices. The study included a group undergoing secondary surgery and reported a higher failure rate, overall, of 31.8% for secondary surgery compared to 18.5% for primary cases (odds ratio (OR) 1.41, 95% confidence interval (CI) 1.18 to 1.91) using the patient global impression of improvement (Yalcin 2003) as the primary outcome. The 46 patients having secondary surgery were discussed in detail in one paper identified in the review search (Abdel-Fattah 2011): 28 women were randomised to receive an inside-out trans-obturator tape (TOT), and 18 women to receive an outside-in TOT. The previous surgeries included colposuspension in 15 women, retropubic TVT in 15 women, trans-obturator tape in 11, and more than one previous surgery in five women. Success rates after the alternative routes of TOT insertion were different but a trend towards greater efficacy of the inside out route of insertion was not statistically significant (Table 2 in the paper). The authors did not provide data on the nature of the previous surgery in the inside-out and outside-in TOT groups included in their analysis. Thus the effectiveness of the two approaches could be compared in women who had only had previous suburethral tape surgery. Risk of bias in included studies We did not identify any relevant trial to be included in this systematic review. Effects of interventions We did not identify any relevant trial to be included in this systematic review. D I S C U S S I O N This review is the first looking at the management of recurrent stress urinary incontinence after failed suburethral tape surgery for urodynamic stress incontinence. Summary of main results This review focused only on randomised or quasi-randomised trials because evidence from uncontrolled series, cohorts or registry data is known to be liable to bias. No studies were identified that were eligible for inclusion in the review, and therefore no trialbased conclusions could be drawn on the best management strategy for recurrent or persistent stress urinary incontinence after a failed suburethral tape. None of the excluded RCTs considered conservative treatment. The randomised trials of surgery that were identified mostly included women whose previous surgery had been with procedures other than suburethral tapes. Authors rarely described the exact nature of previous surgeries. Although several studies have considered the efficacy of secondary suburethral tape surgery, the overwhelming majority of women in many of the studies had underdone non-tape surgery as the primary procedure. One RCT with potentially relevant data had to be excluded because the authors were not able to provide separate data for the women whose previous surgery had been a suburethral tape (Abdel-Fattah 2011). Agreements and disagreements with other studies or reviews Information from non-randomised studies Non-randomised studies are open to bias and their findings must be interpreted with caution. Yet in the absence of randomised trials they provide the only evidence available to inform clinical decisions. Thus, in order to consider what is known about the management of failed tape surgery it is worth considering the literature relating to non-randomised studies. Alternative management strategies A number of studies have considered specific methods for the management of failed suburethral tape insertion. Periurethral bulking agents achieved subjective cure in 8 of 23 patients (35%) with persistent or recurrent incontinence after suburethral tape insertion, which is in keeping with the primary success rates for bulking agents (Lee 2010). Several authors have reported methods of tightening the unsuccessful primary tape by means of sutures to overlap the loose tape. This technique was first described on four patients (Neuman 2004), three of whom became continent in the short term. Lo 2006 reported on 14 patients, with a short term success rate of 71%; and de Landsheere 2010 reported a cure rate from three of seven women, and improvement in a further three. 8

11 However, long term data have not been published, and there are theoretical risks of mesh extrusion or exposure due to folding of the tape. Han 2012 recently reported a retrospective comparison of 36 women having secondary suburethral tape surgery with 30 women having the original tape shortened. The cure rates (unspecified time frame) were 72% for repeat surgery and 47% for tape shortening. Colposuspension was reported to be a successful option for secondary surgery in two small series, with subjective cure rates of 93% and 85% after laparoscopic or open surgery (de Cuyper 2008; Giarenis 2012). Different tape insertion routes Few studies have reported comparative data on different tape insertion routes following failed suburethral tape surgery patients exclusively. Lee 2007 reported a retrospective analysis of 29 patients who underwent secondary surgery after a failed primary surgery (17 women had received a retropubic tape, and 12 a transobturator tape). Overall cure rate for the secondary procedure was 76% (22 of 29), with a trend for retropubic tapes performing better as a secondary procedure (cure rate 92% (12 of 13) versus 63% (10 of 16), P = 0.089). In this series, the previous tape was left in position. Stav 2010 reported data from a large cohort of 1225 patients comparing outcomes between primary and secondary suburethral slings. At mean follow up of 50 months, the subjective cure rate was 62% for the 77 women having repeat surgery compared to 86% for the primary surgery patients (1035). In this non-randomised comparison, repeat retropubic surgery was more successful than repeat trans-obturator surgery (71% versus 48%, P = 0.04). Urgency and urge incontinence were both more common after secondary surgery (30% versus 14%, and 22% versus 5% respectively, P < for both). Single cohort studies A number of single cohort studies have reported surgical outcomes after exclusively primary suburethral tape surgery. Tsivian 2007 reported a subjective cure rate at 23 months of 92%, from 12 patients, with a lower cure rate after transobturator tapes (one of three, compared to all of five after retropubic tapes). van Baelen 2009 reported subjective cure rates from 21 women having trans-obturator tape surgery as a secondary procedure after failed primary tape surgery. Cure rate, defined by the ICIQ-short form questionnaire (Avery 2004), was 53% at 17 months. Liapis 2009 reported outcomes from 31 women after retropubic suburethral tape insertion as secondary surgery; 15 women had received trans-obturator tapes, 6 patients a retropubic tape and 10 patients a single incision tape. No mention was made about whether the previous tape was removed or not. Objective cure based on a 1-hour pad test at 12 months was 74%, and a negative cough stress test during cystometry was seen in 77% of patients. The number of women with each individual primary procedure was 10 or fewer, and no difference in secondary cure rate was seen by primary procedure. Palva 2009 reported on 26 women who had a secondary retropubic tape insertion after failed primary retropubic surgery with a range of different primary tapes including multifilament tapes. Nine women had excision of the primary tape for infection or erosion before secondary surgery. The cure rate after secondary surgery in this cohort was 77%. Sabadell 2011 reported a cure rate of 59% at 24 months after secondary retropubic suburethral sling following unsuccessful primary trans-obturator tape surgery. Systematic review A recent systematic review of the literature on suburethral tapes for recurrent incontinence excluded some of the above studies on methodological grounds. However, the review s conclusions based upon one randomised trial and 11 other papers were similar: suburethral tape surgery appears less effective as a secondary procedure than a primary procedure; and retropubic tapes appear to be more effective than trans-obturator tapes (Pradhan 2012). The authors highlighted the lack of prospective randomised studies. A U T H O R S C O N C L U S I O N S Implications for practice To date there is no high-quality, trial-based evidence that can inform treatment decisions on the management of recurrent SUI after a failed suburethral tape. No randomised comparison studies exist. Conservative treatment options include lifestyle advice, pelvic floor muscle training, bladder training and drugs (medication). Surgical treatment options may include retropubic colposuspension, urethral bulking agents, a fascial sling procedure, artificial urethral sphincter or repeat suburethral tape. Among the literature of non-randomised studies, the data suggest that repeat suburethral tape surgery is less effective than for primary surgery, and there is some evidence that retropubic suburethral tapes are superior to trans-obturator tapes as secondary procedures. In view of the absence of any evidence comparing the alternative management options for failed primary suburethral tape surgery, clinicians must rely largely on expert opinion or personal experience when advising patients about treatment options. 9

12 Implications for research None of the objectives pre-stated in the protocol have been satisfactorily addressed in published trials. The absence of evidence in the management of recurrent or persistent stress incontinence after a failed suburethral tape indicates the need for well-designed randomised controlled clinical trials comparing interventions to answer this question. It is not entirely clear what proportion of women having failed suburethral surgery require a secondary procedure, nor what the management options currently offered by specialists include. However, given the number of suburethral tapes inserted globally each year, it is likely that the numbers involved are significant and that research is warranted. Such surgical trials will necessitate multicentre collaboration. They should include careful pre- and post-surgical assessment to allow evaluation of factors which may influence cure, such as positioning of the original tape, the presence of detrusor overactivity or significant symptoms of urgency, voiding function and the presence or recurrence of co-existing urogenital prolapse. Suggested recommendations have been published recently (Smith 2011). A C K N O W L E D G E M E N T S The review authors would like to acknowledge the support and help of the Cochrane Incontinence Review Group staff. R E F E R E N C E S References to studies excluded from this review Abdel-Fattah 2011 {published data only} Abdel-Fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. Evaluation of transobturator tensionfree vaginal tapes in management of women with recurrent stress urinary incontinence. Urology 2011;77: Ashok 2010 {published data only} Ashok K, Wang A. Recurrent urinary stress incontinence: an overview. Journal of Obstetrics and Gynaecology Research 2010;36: Barber 2008 {published data only} Barber MD, Kleeman S, Karram MM, Paraiso MF, Ellerkmann M, Vasavada S, et al.risk factors associated with failure 1 year after retropubic or transobturator midurethral slings. American Journal of Obstetrics and Gynecology 2008; 199:666.e1 e7. Cardozo 2002 {unpublished data only} Cardozo L, Rufford J. Comparative study of the efficacy, acceptability, morbidity and cost-effectiveness of the Tension Free Vaginal Tape and the periurethral injection of collagen in the management of recurrent stress incontinence [: 16380] Courtney-Watson 2002 {unpublished data only} Courtney-Watson C. Comparison of two surgical methods for curing stress incontinence (recurrent) [: SRINCONT16382] Enzelsberger 1993 {published data only} Enzelsberger H, Kurz C, Seifert M, Raimann H, Schatten C. [Surgical treatment of recurrent stress incontinence: Burch versus lyodura sling operation--a prospective study]. Geburtshilfe Frauenheilkunde 1993;53: Enzelsberger 1996 {published data only} Enzelsberger H, Helmer H, Schatten C. Comparison of Burch and Lyodura sling procedures for repair of unsuccessful incontinence surgery. Obstetrics and Gynecology 1996;88(2): Hilton 2002 {unpublished data only} Hilton P. A prospective randomised comparative trial of a tension-free vaginal tape (TVT) and fascial sling procedure for secondary genuine stress incontinence [: 16383] Lovatsis 2010 {published data only} Lovatsis D, Easton W, Wilkie D, et al.guidelines for the evaluation and treatment of recurrent urinary incontinence following pelvic floor surgery. Journal of Obstetrics and Gynaecology Canada 2010;32: Maher 2004 {published data only} Maher C, Qatawneh A, Baessler K, Cropper M, Schluter P. Laparoscopic colposuspension or tension-free vaginal tape for recurrent stress urinary incontinence and/or intrinsic sphincter deficiency - a randomised controlled trial (Abstract). Neurourology and Urodynamics 2004;23(5/6): Schraffordt 2006 {published data only} Schraffordt Koops SE, Bisseling TM, Heintz AP, Vervest HA. The effectiveness of tension-free vaginal tape (TVT) and quality of life measured in women with previous urogynecologic surgery: analysis from The Netherlands TVT database. American Journal of Obstetrics and Gynecology 2006;195: Wallwiener 1995 {published data only} Wallwiener D, Grischke EM, Rimbach S, Maleika A, Bastert G. Endoscopic retropubic colposuspension: Retziusscopy versus laparoscopy--a reasonable enlargement of the operative spectrum in the management of recurrent stress incontinence?. Endoscopic Surgery & Allied Technologies 1995;3: Additional references Abdel-Fattah 2010 Abdel-Fattah M, Ramsay I, Pringle S, Hardwick C, Ali H, Young D, Mostafa A. Randomised prospective singleblinded study comparing inside-out versus outside-in 10

13 transobturator tapes in the management of urodynamic stress incontinence: 1-year outcomes from the E-TOT study. BJOG 2010;117: Alcalay 1995 Alcalay M, Monga A, Stanton SL. Burch colposuspension: a year follow up. British Journal of Obstetrics and Gynaecology 1995;102: Auwad 2006 Auwad W, Bombieri L, Adekanmi O, Waterfield M, Freeman R. The development of pelvic organ prolapse after colposuspension: a prospective, long-term follow-up study on the prevalence and predisposing factors. International Urogynecology 2006;17: Avery 2004 Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourology and Urodynamics 2004;23: Barrington 1998 Barrington JW, Fulford S, Bales G, Stephenson TP. The modified rectus fascial sling for the treatment of genuine stress incontinence. Journal of Obstetrics and Gynaecology 1998;18:61 2. Breen 1997 Breen JM, Geer BE, May GE. The fascia lata suburethral sling for treating recurrent urinary stress incontinence. American Journal of Obstetrics and Gynecology 1997;177(6): Buckley 2010 Buckley BS, Grant AM, Tincello DG, Wagg AS, Firkins L (On behalf of the James Lind Alliance Priority Setting Partnership on Urinary Incontinence). Prioritising research: patients, carers and clinicians working together to identify and prioritise important clinical uncertainties in urinary incontinence. Neurourology and Urodynamics 2010; Vol. 29, issue 5: [DOI: /nau.20816] Cardozo 1999 Cardozo L, Hextall A, Bailey J, Boos K. Colposuspension after previous failed incontinence surgery: a prospective observational study. British Journal of Obstetrics and Gynaecology 1999;106: de Cuyper 2008 de Cuyper EM, Ismail R, Maher CF. Laparoscopic Burch colposuspension after failed sub-urethral tape procedures: a retrospective audit. International Urogynecology Journal 2008;19: de Landsheere 2010 de Landsheere L, Lucot JP, Foidart JM, Cosson M. Management of recurrent or persistent stress urinary incontinence after TVT-O by mesh readjustment. International Urogynecology Journal 2010;21: Dumoulin 2010 Dumoulin C, Hay-Smith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews 2010, Issue 1. [DOI: / CD pub2; : CD005654] Giarenis 2012 Giarenis I, Mastoroudes H, Cardozo L, Robinson D. Rediscovery of open colposuspension as a salvage continence operation. International Urogynecology Journal 2012;23(8): Han 2012 Han J-Y, Moon KH, Park CM, Choo M-S. Management of recurrent stress urinary incontinence after failed midurethral sling: tape tightening or repeat sling?. International Urogynecology Journal and Pelvic Floor Dysfunction 2012;23: Haylen 2010 Haylen BT, Ridder D, Freeman RM, et al.an International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. International Urogynaecology Journal 2010;21:5 26. Higgins 2003 Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ 2003;327 (7414): Higgins 2011 Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Review of Interventions [updated March 2011]. The Cochrane Collaboration, Available from Hilton 2008 Hilton P. Long-term follow-up studies in pelvic floor dysfunction: the Holy Grail or a realistic aim. BJOG 2008; 115(2): Jackson 1996 Jackson S, Donovan J, Brookes S, Eckford S, Swithinbank L, Abrams P. The Bristol Female Lower Urinary Tract Symptoms questionnaire: development and psychometric testing. British Journal of Urology 1996;77(6): Jarvis 1994 Jarvis GJ. Surgery for genuine stress incontinence. British Journal of Obstetrics and Gynaecology 1994;101: Jeffery 2010 Jeffery ST, De Jong P, Abdool Z, Van Wijk F, Lucente V, Murphy M. Single-incision sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews 2010, Issue 9. [DOI: / CD008709] Kane 1999 Kane L, Chung T, Lawrie H, Iskaros J. Kane L, Chung T, et al.the pubofascial anchor sling procedure for recurrent genuine urinary stress incontinence. British Journal of Urology International 1999;83: Kirchin 2012 Kirchin V, Page T, Keegan PE, Atiemo K, Cody JD, McClinton S. Urethral injection therapy for urinary incontinence in women. Cochrane Database 11

14 of Systematic Reviews 2012, Issue 2. [DOI: / CD pub3] Lapitan 2012 Lapitan MCM, Cody JD. Open retropubic colposuspension for urinary incontinence in women. Cochrane Database of Systematic Reviews 2012, Issue 6. [DOI: / CD pub5] Lee 2007 Lee K-S, Doo CK, Han DH, Jung BJ, Han J-Y, Choo M- S. Outcomes following repeat mid urethral synthetic sling after failure of the initial sling procedure: rediscovery of the tension-free vaginal tape procedure. The Journal of Urology 2007;178: Lee 2010 Lee HN, Lee YS, Han JY, Jeong JY, Choo MS, Lee KS. Transurethral injection of bulking agent for treatment of failed mid-urethral sling procedures. International Urogynecology Journal 2010;21(12): Liapis 2009 Liapis A, Bakas P, Creatsas G. Tension-free vaginal tape in the management of recurrent urodynamic stress incontinence after previous failed midurethral tape. European Urology 2009;55: Lo 2006 Lo T-S, Wang AC, Liang CC, Lee SJ. Treatment for unsuccessful tension-free vaginal tape operation by shortening pre-implanted tape. The Journal of Urology 2006;175: Maher 1999 Maher C, Dwyer P, Carey M, Gilmour D. The Burch colposuspension for recurrent urinary stess incontinence following retropubic continence surgery. British Journal of Obstetrics and Gynaecology 1999;106: Margalith 2004 Margalith I, Gillon G, Gordon D. Urinary incontinence in women under 65: quality of life, stress related to incontinence and patterns of seeking health care. Quality Life Research 2004;13: McGuire 1992 McGuire EJ, Wan J. Pubovaginal slings. In: Hurt WG editor(s). Urogynaecological Surgery. Aspen Publishers, 1992: Merlin 2001 Merlin, T, Arlnold E, Petros P, et al.a systematic review of tension-free urethroplasy for stress urinary incontinence: Intravaginal slingplasty and the tension-free vaginal tape procedures. British Journal of Urology 2001;88: Monga 1994 McGuire Ej, Wan J. Pubovaginal slings. In: Hurt WG editor(s). Urogynaecological Surgery. Aspen Publishers, 1992: Neuman 2004 Neuman M. Trans vaginal tape readjustment after unsuccessful tension-free vaginal tape operation. Neururology and Urodynamics 2004;23: Novara 2010 Novara G, Artibani W, Barber M, Chapple C, Costantini E, Ficarra V, et al.updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings and midurethral tapes in the surgical treatment of female stress urinary incontinence. European Urology 2010; 58(2): Ogah 2009 Ogah J, Cody JD, Rogerson L. Minimally invasive synthetic suburethral sling operations for stress urinary incontinence in women. Cochrane Database of Systematic Reviews 2009, Issue 4. [DOI: / CD pub2] Palva 2009 Palva K, Nilsson CG. Effectiveness of the TVT procedure as a repeat mid-urethra operation for treatment of stress incontinence. International Urogynecology Journal 2009;20: Pradhan 2012 Pradhan A, Jain P, Latthe PM. Effectiveness of midurethral slings in recurrent stress urinary incontinence: a systematic review and meta-analysis. International Urogynecology Journal 2012;23: Rehman 2011 Rehman H, Bezerra CCB, Bruschini H, Cody JD. Traditional suburethral sling operations for urinary incontinence in women. Cochrane Database of Systematic Reviews 2011, Issue 1. [DOI: / CD pub3] Sabadell 2011 Sabadell J, Poza JL, Esgueva A, Morales JC, Sanchez-Iglesias JL, Xercavins J. Usefulness of retropubic tape for recurrent stress incontinence after transobturator tape failure. International Urogynecology Journal 2011;22: Smith 2011 Smith ARB, Artibani W, Drake MJ. Managing unsatisfactory outcome after mid-urethral tape insertion. Neurourology and Urodynamics 2011;30: Stanton 1978 Stanton SL, Cardozo L, Williams JE, Ritchie D, Allan V. Clinical and urodynamic features of failed incontinence surgery in the female. Obstetrics and Gynecology 1978;51: Stav 2010 Stav K, Dwyer PL, Rosamilia A, et al.repeat synthetic mid urethral sling procedure for women with recurrent stress urinary incontinence. The Journal of Urology 2010;183: Thakar 2002 Thakar R, Stanton S, Prodigalidad L, Boon J. Secondary colposuspension: results of a prospective study from a tertiary referral centre. British Journal of Obstetrics and Gynaecology 2002;109:

15 Tsivian 2007 Tsivian A, Neuman M, Yulish E, et al.redo midurethral synthetic sling for female stress urinary incontinence. International Urogynaecology Journal 2007;18:23 6. van Baelen 2009 van Baelen AAA, Delaere KPJ. Repeat transobturator tape after failed mid-urethral sling procedure: follow-up with questionnaire based assessment. Urologia internationalis 2009;83: Ward 2008 Ward KL, Hilton P. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. International Journal of Obstetrics and Gynaecology 2008;115(2): Ware 1993 Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health survey manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Centre, SF- 36 Health survey manual and interpretation guide. Boston (MA): The Health Institute, New England Medical Centre, Yalcin 2003 Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. American Journal of Obstetrics and Gynecology 2003;189: Indicates the major publication for the study 13

16 C H A R A C T E R I S T I C S O F S T U D I E S Characteristics of excluded studies [ordered by study ID] Study Abdel-Fattah 2011 Ashok 2010 Barber 2008 Cardozo 2002 Courtney-Watson 2002 Enzelsberger 1993 Enzelsberger 1996 Hilton 2002 Lovatsis 2010 Maher 2004 Schraffordt 2006 Wallwiener 1995 Reason for exclusion RCT comparing inside-out TVT-O or outside-in trans-obturator tape (TOT). This study contains a subgroup of 46 women from that RCT who had previous incontinence surgery; 31 of the 46 women had previous transobturator tapes, TVT or colposuspension plus suburethral tapes of some kind, but 15 of the women involved had only had a colposuspension. The authors were contacted but we were unable to obtain usable data from their results, as the type of previous surgery was not specified Not RCT. This is a review. Not RCT. This is a secondary analysis using logistic regression to determine risk factors for recurrent UI. The treatment of recurrent UI is not addressed RCT. Authors were contacted but the patients had a previous colposuspension and not a tape procedure Paper could not be found or accessed. RCT but women had hysterectomies with an anterior repair. There was no mention of previous tape surgery This is an RCT but women had hysterectomies with an anterior repair. There was no mention of previous tape surgery RCT. Author was contacted but data were not available as trial was closed prematurely in view of slow recruitment; few of the included participants had previous suburethral tapes Not RCT. This is a clinical guideline. RCT. Author was contacted but data were not complete. Not RCT. This is a prospective cohort. RCT but previous incontinence surgery was not tape. 14

17 D A T A A N D A N A L Y S E S This review has no analyses. A P P E N D I C E S Appendix 1. Search terms for location of randomised studies Cochrane Incontinence Group Specialised Register - search terms ({design.cct*} OR {design.rct*}) AND {topic.urine.incon.recurrent.} OR {topic.urine.incon.stress.recurrent.} (All searches were of the keyword field of Reference Manager 12, Thomson Reuters). Appendix 2. Search methods for location of non-randomised studies One of the review authors performed the following searches for non-randomised studies: MEDLINE using the terms: (previous surgery OR repeat surgery) AND (mid-urethral tape OR sub-urethral tape); Web of knowledge using Science Citation Index was forward searched for papers which had cited some of the papers. W H A T S N E W Last assessed as up-to-date: 18 December Date Event Description 19 December 2012 New citation required and conclusions have changed New review about the treatment of recurrent stress urinary incontinence after failed minimally invasive synthetic suburethral tape surgery in women C O N T R I B U T I O N S O F A U T H O R S Evangelia Bakali contributed to the design of the protocol, wrote the preliminary draft and made changes based on the feedback from the review authors. She was an independent reviewer of eligible studies and wrote the preliminary draft of the review. Brian Buckley contributed to the design of the protocol and critically appraised the protocol. He was an independent reviewer for the eligible studies and contributed in writing the review. Paul Hilton contributed to the design of the protocol and critically appraised the protocol. He contributed in writing the review. Douglas Tincello contributed to the design of the protocol and helped write the preliminary draft. He was the arbitrator for reviewing eligible studies. He helped write the preliminary draft of the review. All authors approved the final version of the review. 15