Single-incision sling operations for urinary incontinence in women.

backgroundUrinary incontinence has been shown to affect up to 50% of women. Studies in the USA have shown that up to 80% of these women have an element of stress urinary incontinence. This imposes significant health and economic burden on society and the women affected. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formation. This has led to the development of third-generation single-incision slings, also referred to as mini-slings.It should be noted that TVT-Secur (Gynecare, Bridgewater, NJ, USA) is one type of single-incision sling; it has been withdrawn from the market because of poor results. However, it is one of the most widely studied single-incision slings and was used in several of the trials included in this review. Despite its withdrawal from clinical use, it was decided that data pertaining to this sling should be included in the first iteration of this review, so that level 1a data are available in the literature to confirm its lack of efficacy.

objectivesTo assess the effectiveness of mini-sling procedures in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events. SEARCH

methodsWe searched: Cochrane Incontinence Specialised Register (includes: CENTRAL, MEDLINE, MEDLINE In-Process) (searched 6 February 2013); ClinicalTrials.gov, WHO ICTRP (searched 20 September 2012); reference lists. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with urodynamic stress incontinence, symptoms of stress incontinence or stress-predominant mixed urinary incontinence, in which at least one trial arm involves one of the new single-incision slings. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)." DATA COLLECTION AND ANALYSIS: Three review authors assessed the methodological quality of potentially eligible trials and independently extracted data from individual trials. MAIN

resultsWe identified 31 trials involving 3290 women. Some methodological flaws were observed in some trials; a summary of these is given in the 'Risk of bias in included studies' section.No studies compared single-incision slings versus no treatment, conservative treatment, colposuspension, laparoscopic procedures or traditional sub-urethral slings. No data on the comparison of single-incision slings versus retropubic mid-urethral slings (top-down approach) were available, but the review authors believe this did not affect the overall comparison versus retropubic mid-urethral slings.Types of single-incision slings included in this review: TVT-Secur (Gynecare); MiniArc (American Medical Systems, Minnetonka, USA); Ajust (CR Bard Inc., Covington, USA); Needleless (Mayumana Healthcare, Lisse, The Netherlands); Ophira (Promedon, Cordoba, Argentina); Tissue Fixation System (TFS PTY Ltd, Sydney, Australia) and CureMesh (DMed Co. Inc., Seoul, Korea).Women were more likely to remain incontinent after surgery with single-incision slings than with retropubic slings such as tension-free vaginal tape (TVT AUTHORS'

conclusionsTVT-Secur is inferior to standard mid-urethral slings for the treatment of women with stress incontinence and has already been withdrawn from clinical use. Not enough evidence has been found on other single-incision slings compared with retropubic or transobturator slings to allow reliable comparisons. A brief economic commentary (BEC) identified two studies which reported no difference in clinical outcomes between single-incision slings and transobturator mid-urethral slings, but single-incision slings may be more cost-effective than transobturator mid-urethral slings based on one-year follow-up. Additional adequately powered and high-quality trials with longer-term follow-up are required. Trials should clearly describe the fixation mechanism of these single-incisions slings: It is apparent that, although clubbed together as a single group, a significant difference in fixation mechanisms may influence outcomes.