Urodynamics tests for the diagnosis and management of bladder outlet obstruction in men: the UPSTREAM non-inferiority RCT.

BACKGROUND: Lower urinary tract symptoms (LUTS) in men may indicate bladder outlet obstruction (BOO) or weakness, known as detrusor underactivity (DU). Severe bothersome LUTS are a common indication for surgery. The diagnostic tests may include urodynamics (UDS) to confirm whether BOO or DU is the cause, potentially reducing the number of people receiving (inappropriate) surgery. OBJECTIVES: The primary objective was to determine whether a care pathway including UDS is no worse for symptom outcome than one in which it is omitted, at 18 months after randomisation. Rates of surgery was the key secondary outcome. DESIGN: This was a pragmatic, multicentre, two-arm (unblinded) randomised controlled trial, incorporating a health economic analysis and qualitative research. SETTING: Urology departments of 26 NHS hospitals in England. PARTICIPANTS: Men (aged ≥ 18 years) seeking further treatment, potentially including surgery, for bothersome LUTS. Exclusion criteria were as follows: unable to pass urine without a catheter, having a relevant neurological disease, currently undergoing treatment for prostate or bladder cancer, previously had prostate surgery, not medically fit for surgery and/or unwilling to be randomised. INTERVENTIONS: Men were randomised to a care pathway based on non-invasive routine tests (control) or routine care plus invasive UDS (intervention arm). MAIN OUTCOME MEASURES: The primary outcome was International Prostate Symptom Score (IPSS) at 18 months after randomisation and the key secondary outcome was rates of surgery. Additional secondary outcomes included adverse events (AEs), quality of life, urinary and sexual symptoms, UDS satisfaction, maximum urinary flow rate and cost-effectiveness. RESULTS: A total of 820 men were randomised (UDS, 427; routine care, 393). Sixty-seven men withdrew before 18 months and 11 died (unrelated to trial procedures). UDS was non-inferior to routine care for IPSS 18 months after randomisation, with a confidence interval (CI) within the margin of 1 point (-0.33, 95% CI -1.47 to 0.80). A lower surgery rate in the UDS arm was not found (38% and 36% for UDS and routine care, respectively), with overall rates lower than expected. AEs were similar between the arms at 43-44%. There were more cases of acute urinary retention in the routine care arm. Patient-reported outcomes for LUTS improved in both arms and satisfaction with UDS was high in men who received it. UDS was more expensive than routine care. From a secondary care perspective, UDS cost an additional £216 over an 18-month time horizon. Quality-adjusted life-years (QALYs) were similar, with a QALY difference of 0.006 in favour of UDS over 18 months. It was established that UDS was acceptable to patients, and valued by both patients and clinicians for its perceived additional insight into the cause and probable best treatment of LUTS. LIMITATIONS: The trial met its predefined recruitment target, but surgery rates were lower than anticipated. CONCLUSIONS: Inclusion of UDS in the diagnostic tests results in a symptom outcome that is non-inferior to a routine care pathway, but does not affect surgical rates for treating BOO. Results do not support the routine use of UDS in men undergoing investigation of LUTS. FUTURE WORK: Focus should be placed on indications for selective utilisation of UDS in individual cases and long-term outcomes of diagnosis and therapy. TRIAL REGISTRATION: Current Controlled Trials ISRCTN56164274. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 42. See the NIHR Journals Library website for further project information.

After hospital referral, men with bothersome lower urinary tract symptoms (LUTS) are assessed with standard tests. These include measurement of urine flow rate, bladder diaries and questionnaires, including the International Prostate Symptom Score (IPSS). UPSTREAM (Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods) researched whether or not including an extra test, urodynamics (UDS), helps when considering treatment options. UDS is a more invasive test and measures pressure in the bladder to check whether or not the prostate is causing obstruction. It was presumed that, if there is no obstruction, surgery would not be offered, so that using UDS would reduce the number of prostate operations. Each man participating (820 in total) was assessed with the standard tests. Around half of them had no extra tests (the 'routine care' arm of the trial); the rest had the UDS tests (the 'UDS' arm). Men then went on to have treatment, which they chose having discussed their test results with a urologist. IPSS and other symptom scores were examined for each man 18 months after joining the trial. At 18 months, surgery outcomes were known for 792 men and IPSS was known for 669 men. We investigated if the two trial arms showed similar changes in the IPSS and if there were fewer operations done in the UDS arm. We identified similar reductions in the IPSS in both arms. However, UDS tests did not reduce the number of operations. Analysing all the costs, it was found that a pathway including UDS costs more than routine care. Interviews were conducted that showed that men found UDS acceptable, and that the additional information helped both the men and their doctors consider which treatment would be most appropriate. These results do not support the routine use of UDS in the assessment of every man considering prostate surgery for LUTS. Further exploration of the data may identify circumstances in which UDS could be helpful.

Traditional suburethral sling operations for urinary incontinence in women.

BACKGROUND: Stress urinary incontinence constitutes a significant health and economic burden to society. Traditional suburethral slings are surgical operations used to treat women with symptoms of stress urinary incontinence. OBJECTIVES: To assess the effectiveness of traditional suburethral sling procedures for treating stress urinary incontinence in women; and summarise the principal findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), as well as MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP); we handsearched journals and conference proceedings (searched 27 February 2017) and the reference lists of relevant articles. On 23 January 2019, we updated this search; as a result, several additional reports of studies are awaiting classification. SELECTION CRITERIA: Randomised or quasi-randomised trials that assessed traditional suburethral slings for treating stress or mixed urinary incontinence. DATA COLLECTION AND ANALYSIS: At least two review authors independently extracted data from included trials and assessed risk of bias. When appropriate, a summary statistic was calculated: risk ratio (RR) for dichotomous data, odds ratio (OR) for continence and cure rates that were expected to be high, and mean difference (MD) for continuous data. We adopted the GRADE approach to assess the quality of evidence. MAIN RESULTS: A total of 34 trials involving 3244 women were included. Traditional slings were compared with 10 other treatments and with each other. We did not identify any trials comparing suburethral slings with no treatment or sham treatment, conservative management, anterior repair, or laparoscopic retropubic colposuspension. Most trials did not distinguish between women having surgery for primary or recurrent incontinence. One trial compared traditional slings with bladder neck needle suspension, and another trial compared traditional slings with single-incision slings. Both trials were too small to be informative. Traditional suburethral sling operation versus drugs One small trial compared traditional suburethral sling operations with oxybutynin to treat women with mixed urinary incontinence. This trial did not report any of our GRADE-specific outcomes. It is uncertain whether surgery compared with oxybutynin leads to more women being dry (83% vs 0%; OR 195.89, 95% confidence interval (CI) 9.91 to 3871.03) or having less urgency urinary incontinence (13% vs 43%; RR 0.29, 95% CI 0.09 to 0.94) because the quality of this evidence is very low. Traditional suburethral sling versus injectables One small trial compared traditional slings with suburethral injectable treatment. The impact of surgery versus injectables is uncertain in terms of the number of continent women (100% were dry with a traditional sling versus 71% with the injectable after the first year; OR 11.57, 95% CI 0.56 to 239.74), the need for repeat surgery for urinary incontinence (RR 0.52, 95% CI 0.05 to 5.36) or the occurrence of perioperative complications (RR 1.57, 95% CI 0.29 to 8.49), as the quality of evidence is very low. Traditional suburethral sling versus open abdominal retropubic colposuspension Eight trials compared slings with open abdominal retropubic colposuspension. Moderate-quality evidence shows that the traditional suburethral sling probably leads to more continent women in the medium term (one to five years) (69% vs 59% after colposuspension: OR 1.70, 95% CI 1.22 to 2.37). High-quality evidence shows that women were less likely to need repeat continence surgery after a traditional sling operation than after colposuspension (RR 0.15, 95% CI 0.05 to 0.42). We found no evidence of a difference in perioperative complications between the two groups, but the CI was very wide and the quality of evidence was very low (RR 1.24, 95% CI 0.83 to 1.86). Traditional suburethral sling operation versus mid-urethral slings Fourteen trials compared traditional sling operations and mid-urethral sling operations. Depending on judgements about what constitutes a clinically important difference between interventions with regard to continence, traditional suburethral slings are probably no better, and may be less effective, than mid-urethral slings in terms of number of women continent in the medium term (one to five years) (67% vs 74%; OR 0.67, 95% CI 0.44 to 1.02; n = 458; moderate-quality evidence). One trial reported more continent women with the traditional sling after 10 years (51% vs 32%: OR 2.22, 95% CI 1.07 to 4.61). Mid-urethral slings may be associated with fewer perioperative complications (RR 1.74, 95% CI 1.16 to 2.60; low-quality evidence). One type of traditional sling operation versus another type of traditional sling operation Nine trials compared one type of traditional sling operation with another. The different types of traditional slings, along with the number of different materials used, mean that trial results could not be pooled due to clinical heterogeneity. Complications were reported by two trials - one comparing non-absorbable Goretex with a rectus fascia sling, and the second comparing Pelvicol with a rectus fascial sling. The impact was uncertain due to the very low quality of evidence. AUTHORS' CONCLUSIONS: Low-quality evidence suggests that women may be more likely to be continent in the medium term (one to five years) after a traditional suburethral sling operation than after colposuspension. It is very uncertain whether there is a difference in urinary incontinence after a traditional suburethral sling compared with a mid-urethral sling in the medium term. However, these findings should be interpreted with caution, as long-term follow-up data were not available from most trials. Long-term follow-up of randomised controlled trials (RCTs) comparing traditional slings with colposuspension and mid-urethral slings is essential. Evidence is insufficient to suggest whether traditional suburethral slings may be better or worse than other management techniques. This review is confined to RCTs and therefore may not identify all of the adverse effects that may be associated with these procedures. A brief economic commentary (BEC) identified three eligible economic evaluations, which are not directly comparable due to differences in methods, time horizons, and settings. End users of this review will need to assess the extent to which methods and results of identified economic evaluations may be applicable (or transferable) to their own setting.

Electrical stimulation with non-implanted devices for stress urinary incontinence in women.

BACKGROUND: Several treatment options are available for stress urinary incontinence (SUI), including pelvic floor muscle training (PFMT), drug therapy and surgery. Problems exist such as adherence to PFMT regimens, side effects linked to drug therapy and the risks associated with surgery. We have evaluated an alternative treatment, electrical stimulation (ES) with non-implanted devices, which aims to improve pelvic floor muscle function to reduce involuntary urine loss. OBJECTIVES: To assess the effects of electrical stimulation with non-implanted devices, alone or in combination with other treatment, for managing stress urinary incontinence or stress-predominant mixed urinary incontinence in women. Among the outcomes examined were costs and cost-effectiveness. 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, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearches of journals and conference proceedings (searched 27 February 2017). We also searched the reference lists of relevant articles and undertook separate searches to identify studies examining economic data. SELECTION CRITERIA: We included randomised or quasi-randomised controlled trials of ES with non-implanted devices compared with any other treatment for SUI in women. Eligible trials included adult women with SUI or stress-predominant mixed urinary incontinence (MUI). We excluded studies of women with urgency-predominant MUI, urgency urinary incontinence only, or incontinence associated with a neurologic condition. We would have included economic evaluations had they been conducted alongside eligible trials. DATA COLLECTION AND ANALYSIS: Two review authors independently screened search results, extracted data from eligible trials and assessed risk of bias, using the Cochrane 'Risk of bias' tool. We would have performed economic evaluations using the approach recommended by Cochrane Economic Methods. MAIN RESULTS: We identified 56 eligible trials (3781 randomised participants). Eighteen trials did not report the primary outcomes of subjective cure, improvement of SUI or incontinence-specific quality of life (QoL). The risk of bias was generally unclear, as most trials provided little detail when reporting their methods. We assessed 25% of the included trials as being at high risk of bias for a variety of reasons, including industry funding and baseline differences between groups. We did not identify any economic evaluations.For subjective cure of SUI, we found moderate-quality evidence that ES is probably better than no active treatment (risk ratio (RR) 2.31, 95% CI 1.06 to 5.02). We found a similar result for cure or improvement of SUI (RR 1.73, 95% CI 1.41 to 2.11), but the quality of evidence was lower. We are very uncertain if there is a difference between ES and sham treatment in terms of subjective cure because of the very low quality of evidence (RR 2.21, 95% CI 0.38 to 12.73). For subjective cure or improvement, ES may be better than sham treatment (RR 2.03, 95% CI 1.02 to 4.07). The effect estimate was 660/1000 women cured/improved with ES compared to 382/1000 with no active treatment (95% CI 538 to 805 women); and for sham treatment, 402/1000 women cured/improved with ES compared to 198/1000 with sham treatment (95% CI 202 to 805 women).Low-quality evidence suggests that there may be no difference in cure or improvement for ES versus PFMT (RR 0.85, 95% CI 0.70 to 1.03), PFMT plus ES versus PFMT alone (RR 1.10, 95% CI 0.95 to 1.28) or ES versus vaginal cones (RR 1.09, 95% CI 0.97 to 1.21).Electrical stimulation probably improves incontinence-specific QoL compared to no treatment (moderate quality evidence) but there may be little or no difference between electrical stimulation and PFMT (low quality evidence). It is uncertain whether adding electrical stimulation to PFMT makes any difference in terms of quality of life, compared with PFMT alone (very low quality evidence). There may be little or no difference between electrical stimulation and vaginal cones in improving incontinence-specific QoL (low quality evidence). The impact of electrical stimulation on subjective cure/improvement and incontinence-specific QoL, compared with vaginal cones, PFMT plus vaginal cones, or drugs therapy, is uncertain (very low quality evidence).In terms of subjective cure/improvement and incontinence-specific QoL, the available evidence comparing ES versus drug therapy or PFMT plus vaginal cones was very low quality and inconclusive. Similarly, comparisons of different types of ES to each other and of ES plus surgery to surgery are also inconclusive in terms of subjective cure/improvement and incontinence-specific QoL (very low-quality evidence).Adverse effects were rare: in total nine of the women treated with ES in the trials reported an adverse effect. We identified insufficient evidence to compare the risk of adverse effects in women treated with ES compared to any other treatment. We were unable to identify any economic data. AUTHORS' CONCLUSIONS: The current evidence base indicated that electrical stimulation is probably more effective than no active or sham treatment, but it is not possible to say whether ES is similar to PFMT or other active treatments in effectiveness or not. Overall, the quality of the evidence was too low to provide reliable results. Without sufficiently powered trials measuring clinically important outcomes, such as subjective assessment of urinary incontinence, we cannot draw robust conclusions about the overall effectiveness or cost-effectiveness of electrical stimulation for stress urinary incontinence in women.

Anterior vaginal repair for urinary incontinence in women.

BACKGROUND: Anterior vaginal repair (anterior colporrhaphy) is an operation traditionally used for moderate or severe stress urinary incontinence (SUI) in women. About a third of adult women experience urinary incontinence. SUI imposes significant health and economic burden to the society and the women affected. OBJECTIVES: To determine the effects of anterior vaginal repair (anterior colporrhaphy) on urinary incontinence in comparison with other management options. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register (searched 1 September 2009) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials that included anterior vaginal repair for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed trial quality. Three trial investigators were contacted for additional information. MAIN RESULTS: Ten trials were identified which included 385 women having an anterior vaginal repair and 627 who received comparison interventions.A single small trial provided insufficient evidence to assess anterior vaginal repair in comparison with physical therapy. The performance of anterior repair in comparison with bladder neck needle suspension appeared similar (risk ratio (RR) for failure after one year 1.16, 95% confidence interval (CI) 0.86 to 1.56), but clinically important differences could not be confidently ruled out. No trials compared anterior repair with suburethral sling operations or laparoscopic colposuspensions, or compared alternative vaginal operations.Anterior vaginal repair was less effective than open abdominal retropubic suspension based on patient-reported cure rates in eight trials both in the medium term (failure rate within one to five years after anterior repair 97/259 (38%) versus 57/327 (17%); RR 2.29, 95% confidence Interval (CI) 1.70 to 3.08) and in the long term (after five years, (49/128 (38%) versus 31/145 (21%); RR 2.02, 95% CI 1.36 to 3.01). There was evidence from three of these trials that this was reflected in a need for more repeat operations for incontinence (25/107 (23%) versus 4/164 (2%); RR 8.87, 95% CI 3.28 to 23.94). These findings held, irrespective of the co-existence of prolapse (pelvic relaxation). Although fewer women had a prolapse after anterior repair (RR 0.24, 95% CI 0.12 to 0.47), later prolapse operation appeared to be equally common after vaginal (3%) or abdominal (4%) operation.In respect of the type of open abdominal retropubic suspension, most data related to comparisons of anterior vaginal repair with Burch colposuspension. The few data describing comparison of anterior repair with the Marshall-Marchetti-Krantz procedure were consistent with those for Burch colposuspension. AUTHORS' CONCLUSIONS: There were not enough data to allow comparison of anterior vaginal repair with physical therapy or needle suspension for primary urinary stress incontinence in women. Open abdominal retropubic suspension appeared to be better than anterior vaginal repair judged on subjective cure rates in eight trials, even in women who had prolapse in addition to stress incontinence (six trials). The need for repeat incontinence surgery was also less after the abdominal operation. However, there was not enough information about postoperative complications and morbidity.A Brief Economic Commentary (BEC) identified one study suggesting that vaginoplasty may be more cost-effective compared with tension-free vaginal tape (TVT-O).

Bladder neck needle suspension for urinary incontinence in women.

BACKGROUND: Bladder neck needle suspension is an operation traditionally used for moderate or severe stress urinary incontinence in women. About a third of adult women experience some urinary incontinence, and about a third of these have moderate or severe symptoms. Stress urinary incontinence (SUI) imposes significant health and economic burdens on society and the women affected. OBJECTIVES: To determine the effects of needle suspension on stress or mixed urinary incontinence in comparison with other management options. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 12 November 2014), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised trials that included needle suspension for the treatment of urinary incontinence. DATA COLLECTION AND ANALYSIS: At least two authors assessed trials and extracted data independently. Two trial investigators provided additional information. MAIN RESULTS: We identified 10 trials, which included 375 women having six different types of needle suspension procedures and 489 who received comparison interventions. Needle suspensions were more likely to fail than open abdominal retropubic suspension. There was a higher subjective failure rate after the first year (91/313 (29%) failed versus 47/297 (16%) failed after open abdominal retropubic suspension). The risk ratio (RR) was 2.00 (95% confidence interval (CI) 1.47 to 2.72), although the difference in peri-operative complications was not significant (17/75 (23%) versus 12/77 (16%); RR 1.44, 95% CI 0.73 to 2.83). There were no significant differences for the other outcome measures. This effect was seen in both women with primary incontinence and women with recurrent incontinence after failed primary operations. Needle suspensions may be as effective as anterior vaginal repair (50/156 (32%) failed after needle suspension versus 64/181 (35%) after anterior repair; RR 0.86, 95% CI 0.64 to 1.16), but there was little information about morbidity. Data for comparison with suburethral slings were inconclusive because they came from a small and atypical population.No trials compared needle suspensions with conservative management, peri-urethral injections, or sham or laparoscopic surgery. AUTHORS' CONCLUSIONS: Bladder neck needle suspension surgery is probably not as good as open abdominal retropubic suspension for the treatment of primary and secondary urodynamic stress incontinence because the cure rates were lower in the trials reviewed. However, the reliability of the evidence was limited by poor quality and small trials. There was not enough information to comment on comparisons with suburethral sling operations. Although cure rates were similar after needle suspension compared with after anterior vaginal repair, the data were insufficient to be reliable and inadequate to compare morbidity. A Brief Economic Commentary (BEC) identified no cost-effectiveness studies comparing bladder neck needle suspension with other surgeries.

Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).

BACKGROUND: The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. METHODS: We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. FINDINGS: Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh trial (430 to standard repair alone, 435 to mesh augmentation) and 735 were included in the graft trial (367 to standard repair alone, 368 to graft augmentation). Because the analyses were carried out separately for each trial (mesh trial and graft trial) some women in the standard repair arm assigned to all treatment options were included in the standard repair group of both trials. 23 of these women did not receive any surgery (15 in the mesh trial, 13 in the graft trial; five were included in both trials) and were included in the baseline analyses only. Mean POP-SS at 1 year did not differ substantially between comparisons (standard 5·4 [SD 5·5] vs mesh 5·5 [5·1], mean difference 0·00, 95% CI -0·70 to 0·71; p=0·99; standard 5·5 [SD 5·6] vs graft 5·6 [5·6]; mean difference -0·15, -0·93 to 0·63; p=0·71). Mean prolapse-related quality-of-life scores also did not differ between groups at 1 year (standard 2·0 [SD 2·7] vs mesh 2·2 [2·7], mean difference 0·13, 95% CI -0·25 to 0·51; p=0·50; standard 2·2 [SD 2·8] vs graft 2·4 [2·9]; mean difference 0·13, -0·30 to 0·56; p=0·54). Mean POP-SS at 2 years were: standard 4·9 (SD 5·1) versus mesh 5·3 (5·1), mean difference 0·32, 95% CI -0·39 to 1·03; p=0·37; standard 4·9 (SD 5·1) versus graft 5·5 (5·7); mean difference 0·32, -0·48 to 1·12; p=0·43. Prolapse-related quality-of-life scores at 2 years were: standard 1·9 (SD 2·5) versus mesh 2·2 (2·6), mean difference 0·15, 95% CI -0·23 to 0·54; p=0·44; standard 2·0 (2·5) versus graft 2·2 (2·8); mean difference 0·10, -0·33 to 0·52; p=0·66. Serious adverse events such as infection, urinary retention, or dyspareunia or other pain, excluding mesh complications, occurred with similar frequency in the groups over 1 year (mesh trial: 31/430 [7%] with standard repair vs 34/435 [8%] with mesh, risk ratio [RR] 1·08, 95% CI 0·68 to 1·72; p=0·73; graft trial: 23/367 [6%] with standard repair vs 36/368 [10%] with graft, RR 1·57, 0·95 to 2·59; p=0·08). The cumulative number of women with a mesh complication over 2 years in women actually exposed to synthetic mesh was 51 (12%) of 434. INTERPRETATION: Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short term, but more than one in ten women had a mesh complication. Therefore, follow-up is vital to identify any longer-term potential benefits and serious adverse effects of mesh or graft reinforcement in vaginal prolapse surgery. FUNDING: UK National Institute of Health Research.

Conservative management for postprostatectomy urinary incontinence.

BACKGROUND: Urinary incontinence is common after both radical prostatectomy and transurethral resection of the prostate (TURP). Conservative management includes pelvic floor muscle training with or without biofeedback, electrical stimulation, extra-corporeal magnetic innervation (ExMI), compression devices (penile clamps), lifestyle changes, or a combination of methods. OBJECTIVES: To assess the effects of conservative management for urinary incontinence after prostatectomy. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (searched 24 August 2011), EMBASE (January 1980 to Week 48 2009), CINAHL (January 1982 to 20 November 2009), the reference lists of relevant articles, handsearched conference proceedings and contacted investigators to locate studies. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials evaluating conservative interventions for urinary continence in men after prostatectomy. DATA COLLECTION AND ANALYSIS: Two or more review authors assessed the methodological quality of trials and abstracted data. We tried to contact several authors of included studies to obtain extra information. MAIN RESULTS: Thirty-seven trials met the inclusion criteria, 33 amongst men after radical prostatectomy, three trials after transurethral resection of the prostate (TURP) and one trial after either operation. The trials included 3399 men, of whom 1937 had an active conservative intervention.  There was considerable variation in the interventions, populations and outcome measures.  Data were not available for many of the pre-stated outcomes.  Men's symptoms improved over time irrespective of management. Adverse effects did not occur or were not reported.There was no evidence from eight trials that pelvic floor muscle training with or without biofeedback was better than control for men who had urinary incontinence after radical prostatectomy (e.g. 57% with urinary incontinence versus 62% in the control group, risk ratio (RR) for incontinence after 12 months 0.85, 95% confidence interval (CI) 0.60 to 1.22) as the confidence intervals were wide, reflecting uncertainty. However, one large multicentre trial of one-to-one therapy showed no difference in any urinary or quality of life outcome measures and had narrower confidence intervals. There was also no evidence of benefit for erectile dysfunction (56% with no erection in the pelvic floor muscle training group versus 55% in the control group after one year, RR 1.01, 95% CI 0.84 to 1.20). Individual small trials provided data to suggest that electrical stimulation, external magnetic innervation or combinations of treatments might be beneficial but the evidence was limited. One large trial demonstrated that there was no benefit for incontinence or erectile dysfunction from a one-to-one pelvic floor muscle training based intervention to men who were incontinent after transurethral resection of the prostate (TURP) (e.g. 65% with urinary incontinence versus 62% in the control group, RR after 12 months 1.05, 95% CI 0.91 to 1.23).In eight trials of conservative treatment of all men after radical prostatectomy aimed at both treatment and prevention, there was an overall benefit from pelvic floor muscle training versus control management in terms of reduction of UI (e.g. 10% with urinary incontinence after one year versus 32% in the control groups, RR for urinary incontinence 0.32, 95% CI 0.20 to 0.51). However, this finding was not supported by other data from pad tests. The findings should be treated with caution, as most trials were of poor to moderate quality and confidence intervals were wide. Men in one trial were more satisfied with one type of external compression device, which had the lowest urine loss, compared to two others or no treatment. The effect of other conservative interventions such as lifestyle changes remains undetermined as no trials involving these interventions were identified. AUTHORS' CONCLUSIONS: The value of the various approaches to conservative management of postprostatectomy incontinence after radical prostatectomy remains uncertain. It seems unlikely that men benefit from one-to-one pelvic floor muscle training therapy after transurethral resection of the prostate (TURP).  Long-term incontinence may be managed by external penile clamp, but there are safety problems.

Surgical management of pelvic organ prolapse in women.

BACKGROUND: Pelvic organ prolapse may occur in up to 50% of parous women. A variety of urinary, bowel and sexual symptoms may be associated with the prolapse. OBJECTIVES: To determine the effects of the many different surgeries used in the management of pelvic organ prolapse. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register (9 February 2009) and reference lists of relevant articles. We also contacted researchers in the field. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that included surgical operations for pelvic organ prolapse. DATA COLLECTION AND ANALYSIS: Trials were assessed and data extracted independently by two review authors. Six investigators were contacted for additional information with five responding. MAIN RESULTS: Forty randomised controlled trials were identified evaluating 3773 women. Abdominal sacral colpopexy was better than vaginal sacrospinous colpopexy in terms of a lower rate of recurrent vault prolapse (RR 0.23, 95% CI 0.07 to 0.77) and less dyspareunia (RR 0.39, 95% CI 0.18 to 0.86). However there was no statistically significant difference in re-operation rates for prolapse (RR 0.46, 95% CI 0.19 to 1.11). The vaginal sacrospinous colpopexy was quicker and cheaper to perform and women had an earlier return to activities of daily living. The three trials contributing to this analysis were clinically heterogeneous.For anterior vaginal wall prolapse, standard anterior repair was associated with more recurrent cystoceles than when supplemented with a polyglactin mesh inlay (RR 1.39, 95% CI 1.02 to 1.90) or porcine dermis mesh inlay (RR 2.72, 95% CI 1.20 to 6.14); but data on morbidity and other clinical outcomes were lacking. Standard anterior repair was associated with more anterior compartment failures on examination than for polypropylene mesh repair as an overlay (RR 2.14, 95% CI 1.23 to 3.74) or armed transobturator mesh (RR 3.55, 95% CI 2.29 to 5.51). Data relating to polypropylene mesh overlay were extracted from conference abstracts without any peer reviewed manuscripts available and should be interpreted with caution. No differences in subjective outcomes, quality of life data, de novo dyspareunia, stress incontinence, re-operation rates for prolapse or incontinence were identified. Blood loss with transobturator meshes was significantly higher than for native tissue anterior repair. Mesh erosions were reported in 10% (30/293) of anterior repairs with polypropylene mesh.For posterior vaginal wall prolapse, the vaginal approach was associated with a lower rate of recurrent rectocele or enterocele, or both, than the transanal approach (RR 0.24, 95% CI 0.09 to 0.64); although there was a higher blood loss and post-operative narcotic use. No data exist on efficacy or otherwise of polypropylene mesh in the posterior vaginal compartment.Meta-analysis on the impact of continence surgery at the time of prolapse surgery was performed with data from seven studies. Continence surgery at the time of prolapse surgery in continent women did not significantly reduce the rate of post-operative stress urinary incontinence (RR 1.39, 95% CI 0.53 to 3.70; random-effects model). AUTHORS' CONCLUSIONS: Abdominal sacral colpopexy was associated with a lower rate of recurrent vault prolapse and dyspareunia than with vaginal sacrospinous colpopexy. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living and increased cost of the abdominal approach. The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse, on examination. Posterior vaginal wall repair may be better than transanal repair in the management of rectoceles in terms of recurrence of prolapse. The value of the addition of a continence procedure to a prolapse repair operation in women who are dry before operation remains to be assessed. Adequately powered randomised controlled clinical trials are urgently needed on a wide variety of issues and particularly need to include women's perceptions of prolapse symptoms.

Oestrogen therapy for urinary incontinence in post-menopausal women.

BACKGROUND: It is possible that oestrogen deficiency may be an aetiological factor in the development of urinary incontinence in women. OBJECTIVES: To assess the effects of local and systemic oestrogens used for the treatment of urinary incontinence. SEARCH STRATEGY: We searched the Cochrane Incontinence Group Specialised Register of trials (2 April 2009) and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials that included oestrogens in at least one arm, in women with symptomatic or urodynamic diagnoses of stress, urgency or mixed urinary incontinence or other urinary symptoms post-menopause. DATA COLLECTION AND ANALYSIS: Trials were evaluated for methodological quality and appropriateness for inclusion by the review authors. Data were extracted by at least two authors and cross checked. Subgroup analyses were performed grouping participants under local or systemic administration. Where appropriate, meta-analysis was undertaken. MAIN RESULTS: Thirty- three trials were identified which included 19,313 (1,262 involved in trials of local administration) incontinent women of whom 9417 received oestrogen therapy. Sample sizes ranged from 16 to 16,117. The trials used varying combinations of type of oestrogen, dose, duration of treatment and length of follow up. Outcome data were not reported consistently and were available for only a minority of outcomes.Systemic administration (of oral oestrogens) resulted in worse incontinence than on placebo (RR 1.32, 95% CI 1.17 to 1.48). This result is heavily weighted by a subgroup of women from the Hendrix trial, which had large numbers of participants and a longer follow up of one year; all the women had had a hysterectomy and the treatment used was conjugated equine oestrogen. The result for women with an intact uterus where oestrogen and progestogen combined were used also showed a statistically significant worsening of incontinence (RR 1.11, 95% CI 1.04 to 1.18).There was some evidence that oestrogens used locally (for example vaginal creams or tablets) may improve incontinence (RR 0.74, 95% CI 0.64 to 0.86). Overall, there were around one to two fewer voids in 24 hours and nocturnal voids amongst women treated with local oestrogen, and there was less frequency and urgency. No serious adverse events were reported although some women experienced vaginal spotting, breast tenderness or nausea.Women who were continent and received systemic oestrogen replacement, with or without progestogens, for reasons other than urinary incontinence were more likely to report the development of new urinary incontinence in one large study.The data were too few to address questions about oestrogens compared with or in combination with other treatments, different types of oestrogen or different modes of delivery. AUTHORS' CONCLUSIONS: Local oestrogen treatment for incontinence may improve or cure it, but there was little evidence from the trials on the period after oestrogen treatment had finished and none about long-term effects. However, systemic hormone replacement therapy, using conjugated equine oestrogen, may make incontinence worse. There were too few data to reliably address other aspects of oestrogen therapy, such as oestrogen type and dose, and no direct evidence on route of administration. The risk of endometrial and breast cancer after long-term use suggests that oestrogen treatment should be for limited periods, especially in those women with an intact uterus.