PROSPECT: 4- and 6-year follow-up of a randomised trial of surgery for vaginal prolapse.

INTRODUCTION AND HYPOTHESIS: Our aim was to compare the mid-term results of native tissue, biological xenograft and polypropylene mesh surgery for women with vaginal wall prolapse. METHODS: A total of 1348 women undergoing primary transvaginal repair of an anterior and/or posterior prolapse were recruited between January 2010 and August 2013 from 35 UK centres. They were randomised by remote allocation to native tissue surgery, biological xenograft or polypropylene mesh. We performed both 4- and 6-year follow-up using validated patient-reported outcome measures. RESULTS: At 4 and 6 years post-operation, there was no clinically important difference in Pelvic Organ Prolapse Symptom Score for any of the treatments. Using a strict composite outcome to assess functional cure at 6 years, we found no difference in cure among the three types of surgery. Half the women were cured at 6 years but only 10.3 to 12% of women had undergone further surgery for prolapse. However, 8.4% of women in the mesh group had undergone further surgery for mesh complications. There was no difference in the incidence of chronic pain or dyspareunia between groups. CONCLUSIONS: At the mid-term outcome of 6 years, there is no benefit from augmenting primary prolapse repairs with polypropylene mesh inlays or biological xenografts. There was no evidence that polypropylene mesh inlays caused greater pain or dyspareunia than native tissue repairs.

Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals.

BACKGROUND: Prostate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. OBJECTIVE: Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce surgery without increasing urinary symptoms. DESIGN, SETTING, AND PARTICIPANTS: UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274). INTERVENTION: Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. RESULTS AND LIMITATIONS: Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo -0.33 [95% confidence interval {CI} -1.47, +0.80]). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. CONCLUSIONS: In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. PATIENT SUMMARY: For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.

Clinical and Patient-reported Outcome Measures in Men Referred for Consideration of Surgery to Treat Lower Urinary Tract Symptoms: Baseline Results and Diagnostic Findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM).

BACKGROUND: Clinical evaluation of male lower urinary tract symptoms (MLUTS) in secondary care uses a range of assessments. It is unknown how MLUTS evaluation influences outcome of therapy recommendations and choice, notably urodynamics (UDS; filling cystometry and pressure flow studies). OBJECTIVE: To report participants' sociodemographic and clinical characteristics, and initial diagnostic findings of the Urodynamics for Prostate Surgery Trial; Randomised Evaluation of Assessment Methods (UPSTREAM). UPSTREAM is a randomised controlled trial evaluating whether symptoms are noninferior and surgery rates are lower if UDS is included. DESIGN, SETTING, AND PARTICIPANTS: A total of 820 men (≥18 yr of age) seeking treatment for bothersome LUTS were recruited from 26 National Health Service hospital urology departments. INTERVENTION: Care pathway based on routine, noninvasive tests (control) or routine care plus UDS (intervention arm). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome is International Prostate Symptom Score (IPSS) and the key secondary outcome is surgery rates 18 mo after randomisation. International Consultation on Incontinence Questionnaires were captured for MLUTS, sexual function, and UDS satisfaction. Baseline clinical and patient-reported outcome measures (PROMs), and UDS findings were informally compared between arms. Trends across age groups for urinary and sexual PROMs were evaluated with a Cuzick's test, and questionnaire items were compared using Pearson's correlation coefficient. RESULTS AND LIMITATIONS: Storage LUTS, notably nocturia, and impaired sexual function are prominent in men being assessed for surgery. Sociodemographic and clinical evaluations were similar between arms. Overall mean IPSS and quality of life scores were 18.94 and 4.13, respectively. Trends were found across age groups, with older men suffering from higher rates of incontinence, nocturia, and erectile dysfunction, and younger men suffering from increased daytime frequency and voiding symptoms. Men undergoing UDS testing expressed high satisfaction with the procedure. CONCLUSIONS: Men being considered for surgery have additional clinical features that may affect treatment decision making and outcomes, notably storage LUTS and impaired sexual function. PATIENT SUMMARY: We describe initial assessment findings from a large clinical study of the treatment pathway for men suffering with bothersome urinary symptoms who were referred to hospital for further treatment, potentially including surgery. We report the patient characteristics and diagnostic test results, including symptom questionnaires, bladder diaries, flow rate tests, and urodynamics.

Adverse events after first, single, mesh and non-mesh surgical procedures for stress urinary incontinence and pelvic organ prolapse in Scotland, 1997-2016: a population-based cohort study.

BACKGROUND: Concerns have been raised about the safety of surgery for stress urinary incontinence and pelvic organ prolapse using transvaginal mesh. We assessed adverse outcomes after first, single mesh procedures and comparable non-mesh procedures. METHODS: We did a cohort study of women in Scotland aged 20 years or older undergoing a first, single incontinence procedure or prolapse procedure during 1997-98 to 2015-16 identified from a national hospital admission database. Primary outcomes were immediate postoperative complications and subsequent (within 5 years) readmissions for later postoperative complications, further incontinence surgery, or further prolapse surgery. Poisson regression models were used to compare outcomes after procedures carried out with and without mesh. FINDINGS: Between April 1, 1997, and March 31, 2016, 16 660 women underwent a first, single incontinence procedure, 13 133 (79%) of which used mesh. Compared with non-mesh open surgery (colposuspension), mesh procedures had a lower risk of immediate complications (adjusted relative risk [aRR] 0·44 [95% CI 0·36-0·55]) and subsequent prolapse surgery (adjusted incidence rate ratio [aIRR] 0·30 [0·24-0·39]), and a similar risk of further incontinence surgery (0·90 [0·73-1·11]) and later complications (1·12 [0·98-1·27]); all ratios are for retropubic mesh. During the same time period, 18 986 women underwent a first, single prolapse procedure, 1279 (7%) of which used mesh. Compared with non-mesh repair, mesh repair of anterior compartment prolapse was associated with a similar risk of immediate complications (aRR 0·93 [95% CI 0·49-1·79]); an increased risk of further incontinence (aIRR 3·20 [2·06-4·96]) and prolapse surgery (1·69 [1·29-2·20]); and a substantially increased risk of later complications (3·15 [2·46-4·04]). Compared with non-mesh repair, mesh repair of posterior compartment prolapse was associated with a similarly increased risk of repeat prolapse surgery and later complications. No difference in any outcome was observed between vaginal and, separately, abdominal mesh repair of vaginal vault prolapse compared with vaginal non-mesh repair. INTERPRETATION: Our results support the use of mesh procedures for incontinence, although further research on longer term outcomes would be beneficial. Mesh procedures for anterior and posterior compartment prolapse cannot be recommended for primary prolapse repair. Both vaginal and abdominal mesh procedures for vaginal vault prolapse repair are associated with similar effectiveness and complication rates to non-mesh vaginal repair. These results therefore do not clearly favour any particular vault repair procedure. FUNDING: None.

Conservative management for postprostatectomy urinary incontinence.

BACKGROUND: Urinary incontinence is common after radical prostatectomy and can also occur in some circumstances after 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 determine the effectiveness of conservative management for urinary incontinence up to 12 months after transurethral, suprapubic, laparoscopic, radical retropubic or perineal prostatectomy, including any single conservative therapy or any combination of conservative therapies. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register (5 February 2014), CENTRAL (2014, Issue 1), EMBASE (January 2010 to Week 3 2014), CINAHL (January 1982 to 18 January 2014), ClinicalTrials.gov and World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (both searched 29 January 2014), and the reference lists of relevant articles. 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 the trials and abstracted data. We tried to contact several authors of included studies to obtain extra information. MAIN RESULTS: Fifty trials met the inclusion criteria, 45 in men after radical prostatectomy, four trials after TURP and one trial after either operation. The trials included 4717 men of whom 2736 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.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 up to 12 months after radical prostatectomy; the quality of the evidence was judged to be moderate (for example 57% with urinary incontinence in the intervention group 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). One large multi-centre trial of one-to-one therapy showed no difference in any urinary or quality of life outcome measures and had narrow CIs. It seems unlikely that men benefit from one-to-one PFMT therapy after TURP. 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. Amongst trials of conservative treatment for all men after radical prostatectomy, aimed at both treatment and prevention, there was moderate evidence of an overall benefit from pelvic floor muscle training versus control management in terms of reduction of urinary incontinence (for example 10% with urinary incontinence after one year in the intervention groups 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 because the risk of bias assessment showed methodological limitations. 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 remained 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. The evidence is conflicting and therefore rigorous, adequately powered randomised controlled trials (RCTs) which abide by the principles and recommendations of the CONSORT statement are still needed to obtain a definitive answer. The trials should be robustly designed to answer specific well constructed research questions and include outcomes which are important from the patient's perspective in decision making and are also relevant to the healthcare professionals. Long-term incontinence may be managed by an external penile clamp, but there are safety problems.

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. 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.

Urodynamic studies for management of urinary incontinence in children and adults.

BACKGROUND: Urodynamic tests are used to investigate people who have urinary incontinence or other urinary symptoms in order to make a definitive, objective diagnosis. The aim is to help select the treatment most likely to be successful. The investigations are invasive and time consuming. OBJECTIVES: The objective of this review was to determine if treatment according to a urodynamic-based diagnosis, compared to treatment based on history and examination, led to more effective clinical care of people with urinary incontinence and better clinical outcomes.The intention was to test the following hypotheses in predefined subgroups of people with incontinence:(i) urodynamic investigations improve the clinical outcomes;(ii) urodynamic investigations alter clinical decision making;(iii) one type of urodynamic test is better than another in improving the outcomes of management of incontinence or influencing clinical decisions, or both. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In-Process, handsearching of journals and conference proceedings (searched 19 February 2013), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing clinical outcomes in groups of people who were and were not investigated using urodynamics, or comparing one type of urodynamic test against another were included. Trials were excluded if they did not report clinical outcomes. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: Eight trials involving around 1100 people were included but data were only available for 1036 women in seven trials, of whom 526 received urodynamics. There was some evidence of risk of bias. The four deaths and 12 dropouts in the control arm of one trial were unexplained.There was significant evidence that the tests did change clinical decision making. Women in the urodynamic arms of three trials were more likely to have their management changed (proportion with change in management compared with the control arm 17% versus 3%, risk ratio (RR) 5.07, 95% CI 1.87 to 13.74), although there was statistical heterogeneity. There was evidence from two trials that women treated after urodynamic investigations were more likely to receive drugs (RR 2.09, 95% CI 1.32 to 3.31). On the other hand, in five trials women undergoing treatment following urodynamic investigation were not more likely to undergo surgery (RR 0.99, 95% CI 0.88 to 1.12).There was no statistically significant difference however in the number of women with urinary incontinence if they received treatment guided by urodynamics (37%) compared with those whose treatment was based on history and clinical findings alone (36%) (for example, RR for the number with incontinence after the first year 1.02, 95% CI 0.86 to 1.21). It was calculated that the number of women needed to treat was 100 women (95% CI 86 to 114 women) undergoing urodynamics to prevent one extra individual being incontinent at one year.One trial reported adverse effects and no significant difference was found (RR 1.10, 95% CI 0.81 to 1.50). AUTHORS' CONCLUSIONS: While urodynamic tests did change clinical decision making, there was some evidence that this did not result in better outcomes in terms of a difference in urinary incontinence rates after treatment. There was no evidence about their use in men, children, or people with neurological diseases. Larger definitive trials are needed in which people are randomly allocated to management according to urodynamic findings or to management based on history and clinical examination to determine if performance of urodynamics results in higher continence rates after treatment.

Case study: a patient-clinician collaboration that identified and prioritized evidence gaps and stimulated research development.

OBJECTIVE: To assess the effect of a research prioritization partnership that aimed to influence the research agenda relating to urinary incontinence (UI). STUDY DESIGN AND SETTING: Research often neglects important gaps in existing evidence so that decisions must be made about treatments without reliable evidence of their effectiveness. In 2007-2009, a United Kingdom partnership of eight patient and 13 clinician organizations identified and prioritized gaps in the evidence that affect everyday decisions about treatment of UI. The top 10 prioritized research questions were published and reported to research funders in 2009. A year later, new research or funding applications relating to the prioritized topics were identified through reviews of research databases and consultation with funding organizations, elements of the research community, and organizations that participated in the partnership. RESULTS: Since dissemination of the prioritized topics, five studies are known to have been funded, three in development; five new systematic reviews are under way, one is being updated; five questions are under consideration by a national research commissioning body. CONCLUSION: The partnership successfully developed and used a methodology for identification and prioritization of research needs through patient-clinician consensus. Prioritization through consensus can be effective in informing the development of clinically useful research.

Urodynamic studies for management of urinary incontinence in children and adults.

BACKGROUND: Urodynamic tests are used to investigate people who have urinary incontinence or other urinary symptoms in order to make a definitive objective diagnosis. The aim is to help to select the treatment most likely to be successful. The investigations are invasive and time consuming. OBJECTIVES: The objective of this review was to discover if treatment according to a urodynamic-based diagnosis, compared to treatment based on history and examination, led to more effective clinical care of urinary incontinence and better clinical outcomes. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and CINAHL, and handsearching of journals and conference proceedings (searched 24 May 2011), and the reference lists of relevant articles. SELECTION CRITERIA: Randomised and quasi-randomised trials comparing clinical outcomes in groups of people who were and were not investigated using urodynamics, or comparing one type of urodynamics against another. Trials were excluded if they did not report clinical outcomes. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. MAIN RESULTS: Seven small trials involving around 400 people were included but data were only available for 385 women in five trials, of whom 197 received urodynamics. There was some evidence of risk of bias. The four deaths and 12 dropouts in the control arm of one trial were unexplained.There was some evidence that the tests did change clinical decision making. There was evidence from two trials that women treated after urodynamic investigations were more likely to receive drugs (RR 2.09, 95% CI 1.32 to 3.31) but not, in three trials, surgery (RR 1.75, 95% CI 0.39 to 7.75). Women in the urodynamic arms of two trials were more likely to have their management changed but this did not quite reach statistical significance (proportion with no change in management 76% versus 99%, RR 0.79, 95% CI 0.57 to 1.10).However, there was not enough evidence to demonstrate whether or not this resulted in a clinical benefit. For example there was no statistically significant difference in the number of women with urinary incontinence if they received treatment guided by urodynamics (70%) versus those whose treatment was based on history and clinical findings alone (62%) (e.g. RR for number with incontinence after first year 1.23, 95% CI 0.60 to 2.55).No trials reported whether or not there were any adverse effects. AUTHORS' CONCLUSIONS: While urodynamic tests may change clinical decision making, there was not enough evidence to suggest whether this would result in better clinical outcomes. There was no evidence abut their use in men, children or people with neurological diseases. Larger definitive trials are needed, in which people are randomly allocated to management according to urodynamic findings or to standard management based on history and clinical examination.

Surgical management of pelvic organ prolapse in women: the updated summary version Cochrane review.

INTRODUCTION AND HYPOTHESIS: A previous version of the Cochrane review for prolapse surgery in 2008 provided two conclusions: abdominal sacrocolpopexy had lower recurrent vault prolapse rates than sacrospinous colpopexy but this was balanced against a longer time to return to activities of daily life. An additional continence procedure at the time of prolapse surgery might be beneficial in reducing post-operative stress urinary incontinence; however, this was weighed against potential adverse effects. The aim of this review is to provide an updated summary version of the current Cochrane review on the surgical management of pelvic organ prolapse. METHODS: We searched the Cochrane Incontinence Group Specialised Register and reference lists of randomised or quasi-randomised controlled trials on surgery for pelvic organ prolapse. Trials were assessed independently by two reviewers. RESULTS: We identified 40 trials including 18 new and three updates. There were no additional studies on surgery for posterior prolapse. Native tissue anterior repair was associated with more anterior compartment failures than polypropylene mesh repair as an overlay (RR 2.14, 95% CI 1.23-3.74) or armed transobturator mesh (RR 3.55, 95% CI 2.29-5.51). There were no differences in subjective outcomes, quality of life data, de novo dyspareunia, stress urinary incontinence, reoperation rates for prolapse or incontinence, although some of these data were limited. Mesh erosions were reported in 10% (30/293). Including new studies on the impact of continence surgery at the time of prolapse surgery, meta-analysis revealed that concurrent continence surgery did not significantly reduce the rate of post-operative stress urinary incontinence (RR 1.39, 95% CI 0.53-3.70; random-effects model). CONCLUSION: The inclusion of new randomised controlled trials showed that the use of mesh at the time of anterior vaginal wall repair reduced the risk of recurrent anterior vaginal wall prolapse on examination. However, this was not translated into improved functional or quality of life outcomes. The value of a continence procedure in addition to a prolapse operation in women who are continent pre-operatively remains uncertain. Adequately powered randomised controlled trials are needed and should particularly include women's perceptions of prolapse symptoms and functional outcome.

Persistent urinary incontinence and delivery mode history: a six-year longitudinal study.

OBJECTIVE: To investigate the prevalence of persistent and long term postpartum urinary incontinence and associations with mode of first and subsequent delivery. DESIGN: Longitudinal study. SETTING: Maternity units in Aberdeen (Scotland), Birmingham (England) and Dunedin (New Zealand). POPULATION: Women (4214) who returned postal questionnaires three months and six years after the index birth. METHODS: Symptom data were obtained from both questionnaires and obstetric data from case-notes for the index birth and the second questionnaire for subsequent births. Logistic regression investigated the independent effects of mode of first delivery and delivery mode history. MAIN OUTCOME MEASURES: Urinary incontinence-persistent (at three months and six years after index birth) and long term (at six years after index birth). RESULTS: The prevalence of persistent urinary incontinence was 24%. Delivering exclusively by caesarean section was associated with both less persistent (OR=0.46, 95% CI 0.32-0.68) and long term urinary incontinence (OR=0.50, 95% CI 0.40-0.63). Caesarean section birth in addition to vaginal delivery, however, was not associated with significantly less persistent incontinence (OR 0.93, 95% CI 0.67-1.29). There were no significant associations between persistent or long term urinary incontinence and forceps or vacuum extraction delivery. Other significantly associated factors were increasing number of births and older maternal age. CONCLUSIONS: The risk of persistent and long term urinary incontinence is significantly lower following caesarean section deliveries but not if there is another vaginal birth. Even when delivering exclusively by caesarean section, the prevalence of persistent symptoms (14%) is still high.

Incontinence-specific quality of life measures used in trials of treatments for female urinary incontinence: a systematic review.

This systematic review examined the use of incontinence-specific quality of life (QOL) measures in clinical trials of female incontinence treatments, and systematically evaluated their quality using a standard checklist. Of 61 trials included in the review, 58 (95.1%) used an incontinence-specific QOL measure. The most commonly used were IIQ (19 papers), I-QoL (12 papers) and UDI (9 papers). Eleven papers (18.0%) used measures which were not referenced or were developed specifically for the study. The eight QOL measures identified had good clinical face validity and measurement properties. We advise researchers to evaluate carefully the needs of their specific study, and select the QOL measure that is most appropriate in terms of validity, utility and relevance, and discourage the development of new measures. Until better evidence is available on the validity and comparability of measures, we recommend that researchers consider using IIQ or I-QOL with or without UDI in trials of incontinence treatments.

Randomised controlled trial of conservative management of postnatal urinary and faecal incontinence: six year follow up.

OBJECTIVE: To determine the long term effects of a conservative nurse-led intervention for postnatal urinary incontinence. DESIGN: Randomised controlled trial. SETTING: Community based intervention in three centres in the United Kingdom and New Zealand. PARTICIPANTS: 747 women with urinary incontinence at three months after childbirth, of whom 516 were followed up again at 6 years (69%). INTERVENTION: Active conservative treatment (pelvic floor muscle training and bladder training) at five, seven, and nine months after delivery or standard care. MAIN OUTCOME MEASURES: Urinary and faecal incontinence, performance of pelvic floor muscle training. RESULTS: Of 2632 women with urinary incontinence, 747 participated in the original trial. The significant improvements relative to controls in urinary (60% v 69%) and faecal (4% v 11%) incontinence at one year were not found at six year follow up (76% v 79% (95% confidence interval for difference in means -10.2% to 4.1%) for urinary incontinence, 12% v 13% (-6.4% to 5.1%) for faecal incontinence) irrespective of subsequent obstetric events. In the short term the intervention had motivated more women to perform pelvic floor muscle training (83% v 55%) but this fell to 50% in both groups in the long term. Both urinary and faecal incontinence increased in prevalence in both groups during the study period. CONCLUSIONS: The moderate short term benefits of a brief nurse-led conservative treatment of postnatal urinary incontinence may not persist, even among women with no further deliveries. About three quarters of women with urinary incontinence three months after childbirth still have this six years later.

Cost effectiveness of tension-free vaginal tape for the surgical management of female stress incontinence.

OBJECTIVES: Stress urinary incontinence affects between 10 percent and 50 percent of women. Surgery is commonly recommended for troublesome incontinence that does not respond to nonsurgical management. Tension-free vaginal tape (TVT) is a newer, minimal access surgical sling procedure, which is being increasingly adopted worldwide. The cost-effectiveness of TVT in comparison with other surgical procedures, particularly open colposuspension, is assessed. METHODS: Effectiveness estimates came from a systematic review of TVT compared with other surgical procedures (open and laparoscopic colposuspension, traditional slings, and injectables). Deterministic and probabilistic analyses were used to assess the likelihood of TVT being cost-effective. Sensitivity analyses assessed the impact of changing assumptions about cure rates and costs for TVT, cure rates for retreatment open colposuspension, and proportions of women who choose retreatment. RESULTS: Reliable estimates of relative effectiveness were difficult to derive because the few randomized controlled comparisons had not been optimally analyzed or fully reported. Results of the economic model suggested that TVT dominates open colposuspension (lower cost and same quality of life years [QALYs]) within 5 years after surgery. Stochastic analysis indicated that the likelihood of TVT being cost-effective was 100 percent if decision-makers are unwilling to pay for additional QALYs. TVT's dominance depended on the assumption fact that retreatment open colposuspension has lower cure rates than a first colposuspension. CONCLUSIONS: Analysis based on current short-term data indicates dominance of TVT over open colposuspension from approximately 5 years. There is a need for longer-term follow-up data from methodologically rigorous randomized trials to provide a sounder basis for estimating the relative benefits and cost implications.

Treating nocturnal enuresis in children: review of evidence.

BACKGROUND: Childhood nocturnal enuresis (bedwetting) affects many families. Although it has a high rate of spontaneous remission, bedwetting may bring social and emotional stigma, stress, and inconvenience to both the child with enuresis and his or her family. DESIGN: Summary of systematic reviews of treatment for nocturnal enuresis in children, published in the Cochrane Library, using evidence only from randomized and quasi-randomized trials to compare interventions. Interventions included behavioral, alarm, and pharmacologic treatments. SETTING AND METHODS: Six Cochrane Reviews contributed evidence to this review: simple behavioral interventions, alarms, complex behavioral or educational interventions, desmopressin, tricyclics and related drugs, and other drugs. SUBJECTS: The participants were children (usually up to the age of 16). RESULTS: Much of the available evidence was of poor quality, and there were few direct comparisons between different types of intervention. Simple behavioral Interventions, such as reward systems, are widely used as standard first-line treatment, but they require a high level of parental involvement. There is currently little evidence to show that these interventions work, but they may be worth trying because they have only a few adverse effects. The use of an alarm intervention reduced nighttime bed wetting in a majority of children both during and after treatment. Overlearning or dry-bed training may reduce the relapse rate. Before embarking on alarm treatment, families need to be made aware of both the time and the high level of parental involvement necessary to attain success. Drug therapy, such as desmopressin and tricyclics, reduced the number of wet nights per week compared with placebo but only while the drug was used. Patients and their families need to be warned about possible side effects of some of the drugs. CONCLUSIONS: Alarms are the most effective treatment for nocturnal enuresis in children, but desmopressin may be considered for temporary relief.

Predicting conception.

Infertility is relative. Research into effective treatment must focus on couples with single, identifiable causes for their infertility, and must take into account the effect of chance and time on eventual success. Women with ovulatory infertility, who have no other subfertility factors, can expect normal conception rates when ovulation is restored. Unfortunately, there is no similar simple treatment for male infertility, although complicated and expensive treatment may help. Selection of the couples most likely to benefit from such help will result in the most cost-effective use of scarce resources. Knowledge of duration of infertility and the postcoital test result can help to identify those couples who have a reasonable chance of conception without treatment and those who have virtually no chance without it.