Single-incision sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence imposes a significant health and economic burden on individuals and society. Single-incision slings are a minimally-invasive treatment option for stress urinary incontinence. They involve passing a short synthetic device through the anterior vaginal wall to support the mid-urethra. The use of polypropylene mesh in urogynaecology, including mid-urethral slings, is restricted in many countries. This is a review update (previous search date 2012). OBJECTIVES: To assess the effects of single-incision sling operations for treating urinary incontinence in women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from: CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, and two trials registers. We handsearched journals, conference proceedings, and reference lists of relevant articles to 20 September 2022. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials in women with stress (or stress-predominant mixed) urinary incontinence in which at least one, but not all, trial arms included a single-incision sling. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. The primary outcome was subjective cure or improvement of urinary incontinence. MAIN RESULTS: We included 62 studies with a total of 8051 women in this review. We did not identify any studies comparing single-incision slings to no treatment, conservative treatment, colposuspension, or laparoscopic procedures. We assessed most studies as being at low or unclear risk of bias, with five studies at high risk of bias for outcome assessment. Sixteen trials used TVT-Secur, a single-incision sling withdrawn from the market in 2013. The primary analysis in this review excludes trials using TVT-Secur. We report separate analyses for these trials, which did not substantially alter the effect estimates. We identified two cost-effectiveness analyses and one cost-minimisation analysis. Single-incision sling versus autologous fascial sling One study (70 women) compared single-incision slings to autologous fascial slings. It is uncertain if single-incision slings have any effect on risk of dyspareunia (painful sex) or mesh exposure, extrusion or erosion compared with autologous fascial slings. Subjective cure or improvement of urinary incontinence at 12 months, patient-reported pain at 24 months or longer, number of women with urinary retention, quality of life at 12 months and the number of women requiring repeat continence surgery or sling revision were not reported for this comparison. Single-incision sling versus retropubic sling Ten studies compared single-incision slings to retropubic slings. There may be little to no difference between single-incision slings and retropubic slings in subjective cure or improvement of incontinence at 12 months (risk ratio (RR) 0.99, 95% confidence interval (CI) 0.91 to 1.07; 2 trials, 297 women; low-certainty evidence). It is uncertain whether single-incision slings increase the risk of mesh exposure, extrusion or erosion compared with retropubic minimally-invasive slings; the wide confidence interval is consistent with both benefit and harm (RR 1.55, 95% CI 0.24 to 9.82; 3 trials, 267 women; low-certainty evidence). It is uncertain whether single-incision slings lead to fewer women having postoperative urinary retention compared with retropubic slings; the wide confidence interval is consistent with possible benefit and harm (RR 0.47, 95% CI 0.12 to 1.84; 2 trials, 209 women; low-certainty evidence). The effect of single-incision slings on the risk of repeat continence surgery or mesh revision compared with retropubic slings is uncertain (RR 4.19, 95% CI 0.31 to 57.28; 2 trials, 182 women; very low-certainty evidence). One study reported quality of life, but not in a suitable format for analysis. Patient-reported pain at more than 24 months and the number of women with dyspareunia were not reported for this comparison. We downgraded the evidence due to concerns about risks of bias, imprecision and inconsistency. Single-incision sling versus transobturator sling Fifty-one studies compared single-incision slings to transobturator slings. The evidence ranged from high to low certainty. There is no evidence of a difference in subjective cure or improvement of incontinence at 12 months when comparing single-incision slings with transobturator slings (RR 1.00, 95% CI 0.97 to 1.03; 17 trials, 2359 women; high-certainty evidence). Single-incision slings probably have a reduced risk of patient-reported pain at 24 months post-surgery compared with transobturator slings (RR 0.12, 95% CI 0.02 to 0.68; 2 trials, 250 women; moderate-certainty evidence). The effect of single-incision slings on the risk of dyspareunia is uncertain compared with transobturator slings, as the wide confidence interval is consistent with possible benefit and possible harm (RR 0.78, 95% CI 0.41 to 1.48; 8 trials, 810 women; moderate-certainty evidence). There are a similar number of mesh exposures, extrusions or erosions with single-incision slings compared with transobturator slings (RR 0.61, 95% CI 0.39 to 0.96; 16 trials, 2378 women; high-certainty evidence). Single-incision slings probably result in similar or reduced cases of postoperative urinary retention compared with transobturator slings (RR 0.68, 95% CI 0.47 to 0.97; 23 trials, 2891 women; moderate-certainty evidence). Women with single-incision slings may have lower quality of life at 12 months compared to transobturator slings (standardised mean difference (SMD) 0.24, 95% CI 0.09 to 0.39; 8 trials, 698 women; low-certainty evidence). It is unclear whether single-incision slings lead to slightly more women requiring repeat continence surgery or mesh revision compared with transobturator slings (95% CI consistent with possible benefit and harm; RR 1.42, 95% CI 0.94 to 2.16; 13 trials, 1460 women; low-certainty evidence). We downgraded the evidence due to indirectness, imprecision and risks of bias. AUTHORS' CONCLUSIONS: Single-incision sling operations have been extensively researched in randomised controlled trials. They may be as effective as retropubic slings and are as effective as transobturator slings for subjective cure or improvement of stress urinary incontinence at 12 months. It is uncertain if single-incision slings lead to better or worse rates of subjective cure or improvement compared with autologous fascial slings. There are still uncertainties regarding adverse events and longer-term outcomes. Therefore, longer-term data are needed to clarify the safety and long-term effectiveness of single-incision slings compared to other mid-urethral slings.

Oestrogen therapy for treating pelvic organ prolapse in postmenopausal women.

BACKGROUND: Pelvic organ prolapse (POP) is the descent of a woman's uterus, bladder, or rectum into the vagina. It affects 50% of women over 50 years old who have given birth to at least one child, and recognised risk factors are older age, higher number of births, and higher body mass index. This review assesses the effects of oestrogen therapy, alone or in combination with other treatments, on POP in postmenopausal women. OBJECTIVES: To assess the benefits and harms of local and systemic oestrogen therapy in the management of pelvic organ prolapse symptoms in postmenopausal women, and to summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (up to 20 June 2022), which includes CENTRAL, MEDLINE, two trials registers, and handsearching of journals and conference proceedings. We also checked the reference lists of relevant articles for additional studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs), quasi-RCTs, multi-arm RCTs, and cross-over RCTs that evaluated the effects of oestrogen therapy (alone or in combination with other treatments) versus placebo, no treatment, or other interventions in postmenopausal women with any grade of POP. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data from the included trials using prespecified outcome measures and a piloted extraction form. The same review authors independently assessed the risk of bias of eligible trials using Cochrane's risk of bias tool. Had data allowed, we would have created summary of findings tables for our main outcome measures and assessed the certainty of the evidence using GRADE. MAIN RESULTS: We identified 14 studies including a total of 1002 women. In general, studies were at high risk of bias in terms of blinding of participants and personnel, and there were also some concerns about selective reporting. Owing to insufficient data for the outcomes of interest, we were unable to perform our planned subgroup analyses (systemic versus topical oestrogen, parous versus nulliparous women, women with versus without a uterus). No studies assessed the effects of oestrogen therapy alone versus no treatment, placebo, pelvic floor muscle training, devices such as vaginal pessaries, or surgery. However, we did identify three studies that assessed oestrogen therapy in conjunction with vaginal pessaries versus vaginal pessaries alone and 11 studies that assessed oestrogen therapy in conjunction with surgery versus surgery alone. AUTHORS' CONCLUSIONS: There was insufficient evidence from RCTs to draw any solid conclusions on the benefits or harms of oestrogen therapy for managing POP symptoms in postmenopausal women. Topical oestrogen in conjunction with pessaries was associated with fewer adverse vaginal events compared with pessaries alone, and topical oestrogen in conjunction with surgery was associated with reduced postoperative urinary tract infections compared with surgery alone; however, these findings should be interpreted with caution, as the studies that contributed data varied substantially in their design. There is a need for larger studies on the effectiveness and cost-effectiveness of oestrogen therapy, used alone or in conjunction with pelvic floor muscle training, vaginal pessaries, or surgery, for the management of POP. These studies should measure outcomes in the medium and long term.

Conservative interventions for managing urinary incontinence after prostate surgery.

BACKGROUND: Men may need to undergo prostate surgery to treat prostate cancer or benign prostatic hyperplasia. After these surgeries, men may experience urinary incontinence (UI). Conservative treatments such as pelvic floor muscle training (PFMT), electrical stimulation and lifestyle changes can be undertaken to help manage the symptoms of UI. OBJECTIVES: To assess the effects of conservative interventions for managing urinary incontinence after prostate surgery. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP and handsearched journals and conference proceedings (searched 22 April 2022). We also searched the reference lists of relevant articles. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs of adult men (aged 18 or over) with UI following prostate surgery for treating prostate cancer or LUTS/BPO. We excluded cross-over and cluster-RCTs. We investigated the following key comparisons: PFMT plus biofeedback versus no treatment; sham treatment or verbal/written instructions; combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions; and electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions. DATA COLLECTION AND ANALYSIS: We extracted data using a pre-piloted form and assessed risk of bias using the Cochrane risk of bias tool. We used the GRADE approach to assess the certainty of outcomes and comparisons included in the summary of findings tables. We used an adapted version of GRADE to assess certainty in results where there was no single effect measurement available. MAIN RESULTS: We identified 25 studies including a total of 3079 participants. Twenty-three studies assessed men who had previously undergone radical prostatectomy or radical retropubic prostatectomy, while only one study assessed men who had undergone transurethral resection of the prostate. One study did not report on previous surgery. Most studies were at high risk of bias for at least one domain. The certainty of evidence assessed using GRADE was mixed. PFMT plus biofeedback versus no treatment, sham treatment or verbal/written instructions Four studies reported on this comparison. PFMT plus biofeedback may result in greater subjective cure of incontinence from 6 to 12 months (1 study; n = 102; low-certainty evidence). However, men undertaking PFMT and biofeedback may be less likely to be objectively cured at from 6 to 12 months (2 studies; n = 269; low-certainty evidence). It is uncertain whether undertaking PFMT and biofeedback has an effect on surface or skin-related adverse events (1 study; n = 205; very low-certainty evidence) or muscle-related adverse events (1 study; n = 205; very low-certainty evidence). Condition-specific quality of life, participant adherence to the intervention and general quality of life were not reported by any study for this comparison. Combinations of conservative treatments versus no treatment, sham treatment or verbal/written instructions Eleven studies assessed this comparison. Combinations of conservative treatments may lead to little difference in the number of men being subjectively cured or improved of incontinence between 6 and 12 months (RR 0.97, 95% CI 0.79 to 1.19; 2 studies; n = 788; low-certainty evidence; in absolute terms: no treatment or sham arm: 307 per 1000 and intervention arm: 297 per 1000). Combinations of conservative treatments probably lead to little difference in condition-specific quality of life (MD -0.28, 95% CI -0.86 to 0.29; 2 studies; n = 788; moderate-certainty evidence) and probably little difference in general quality of life between 6 and 12 months (MD -0.01, 95% CI -0.04 to 0.02; 2 studies; n = 742; moderate-certainty evidence). There is little difference between combinations of conservative treatments and control in terms of objective cure or improvement of incontinence between 6 and 12 months (MD 0.18, 95% CI -0.24 to 0.60; 2 studies; n = 565; high-certainty evidence). However, it is uncertain whether participant adherence to the intervention between 6 and 12 months is increased for those undertaking combinations of conservative treatments (RR 2.08, 95% CI 0.78 to 5.56; 2 studies; n = 763; very low-certainty evidence; in absolute terms: no intervention or sham arm: 172 per 1000 and intervention arm: 358 per 1000). There is probably no difference between combinations and control in terms of the number of men experiencing surface or skin-related adverse events (2 studies; n = 853; moderate-certainty evidence), but it is uncertain whether combinations of treatments lead to more men experiencing muscle-related adverse events (RR 2.92, 95% CI 0.31 to 27.41; 2 studies; n = 136; very low-certainty evidence; in absolute terms: 0 per 1000 for both arms). Electrical or magnetic stimulation versus no treatment, sham treatment or verbal/written instructions We did not identify any studies for this comparison that reported on our key outcomes of interest. AUTHORS' CONCLUSIONS: Despite a total of 25 trials, the value of conservative interventions for urinary incontinence following prostate surgery alone, or in combination, remains uncertain. Existing trials are typically small with methodological flaws. These issues are compounded by a lack of standardisation of the PFMT technique and marked variations in protocol concerning combinations of conservative treatments. Adverse events following conservative treatment are often poorly documented and incompletely described. Hence, there is a need for large, high-quality, adequately powered, randomised control trials with robust methodology to address this subject.