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A randomized trial of urodynamic testing before stress-incontinence surgery.

ABSTRACT: Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

SUBMITTER: Nager CW

PROVIDER: S-EPMC3386296 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature

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A randomized trial of urodynamic testing before stress-incontinence surgery.

Nager Charles W CW Brubaker Linda L Litman Heather J HJ Zyczynski Halina M HM Varner R Edward RE Amundsen Cindy C Sirls Larry T LT Norton Peggy A PA Arisco Amy M AM Chai Toby C TC Zimmern Philippe P Barber Matthew D MD Dandreo Kimberly J KJ Menefee Shawn A SA Kenton Kimberly K Lowder Jerry J Richter Holly E HE Khandwala Salil S Nygaard Ingrid I Kraus Stephen R SR Johnson Harry W HW Lemack Gary E GE Mihova Marina M Albo Michael E ME Mueller Elizabeth E Sutkin Gary G Wilson Tracey S TS Hsu Yvonne Y Rozanski Thomas A TA Rickey Leslie M LM Rahn David D Tennstedt Sharon S Kusek John W JW Gormley E Ann EA

The New England journal of medicine 20120502 21

<h4>Background</h4>Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.<h4>Methods</h4>We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a redu ...[more]

PMID: 22551104

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Project description:BackgroundStress urinary incontinence (SUI) is common after radical prostatectomy and likely to persist despite conservative treatment. The sling is an emerging operation for persistent SUI, but randomised controlled trial (RCT) comparison with the established artificial urinary sphincter (AUS) is lacking.ObjectiveTo compare the outcomes of surgery in men with bothersome urodynamic SUI after prostate surgery.Design, setting, and participantsA noninferiority RCT was conducted among men with bothersome urodynamic SUI from 27 UK centres. Blinding was not possible due the surgeries.InterventionParticipants were randomly assigned (1:1) to the male transobturator sling (n = 190) or the AUS (n = 190) group.Outcome measurements and statistical analysisThe primary outcome was patient-reported SUI 12 mo after randomisation, collected from postal questionnaire using a composite outcome from two items in validated International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form questionnaire (ICIQ-UI SF). Noninferiority margin was 15%, thought to be of acceptable lower effectiveness, in return for reduced adverse events (AEs) and easier operation, for the sling. Secondary outcomes were operative and postoperative details, patient-reported measures, and AEs, up to 12 mo after surgery.Results and limitationsA total of 380 participants were included. At 12 mo after randomisation, incontinence rates were 134/154 (87.0%) for male sling versus 133/158 (84.2%) for AUS (difference 3.6% [95% confidence interval {CI} -11.6 to 4.6], pNI = 0.003), showing noninferiority. Incontinence symptoms (ICIQ-UI SF) reduced from scores of 16.1 and 16.4 at baseline to 8.7 and 7.5 for male sling and AUS, respectively (mean difference 1.4 [95% CI 0.2-2.6], p = 0.02). Serious AEs (SAEs) were few: n = 6 and n = 13 for male sling and AUS (one man had three SAEs), respectively. Quality of life scores improved, and satisfaction was high in both groups. All other secondary outcomes that show statistically significant differences favour the AUS.ConclusionsUsing a strict definition, urinary incontinence rates remained high, with no evidence of difference between male sling and AUS. Symptoms and quality of life improved significantly in both groups, and men were generally satisfied with both procedures. Overall, secondary and post hoc analyses were in favour of AUS.Patient summaryUrinary incontinence after prostatectomy has considerable effect on men's quality of life. MASTER shows that if surgery is needed, both surgical options result in fewer symptoms and high satisfaction, despite most men not being completely dry. However, most other results indicate that men having an artificial urinary sphincter have better outcomes than those who have a sling.

Project description:BackgroundStress urinary incontinence (SUI) is a frequent adverse effect for men undergoing prostate surgery. A large proportion (around 8% after radical prostatectomy and 2% after transurethral resection of prostate (TURP)) are left with severe disabling incontinence which adversely effects their quality of life and many are reliant on containment measures such as pads (27% and 6% respectively). Surgery is currently the only option for active management of the problem. The overwhelming majority of surgeries for persistent bothersome SUI involve artificial urinary sphincter (AUS) insertion. However, this is expensive, and necessitates manipulation of a pump to enable voiding. More recently, an alternative to AUS has been developed - a synthetic sling for men which elevates the urethra, thus treating SUI. This is thought, by some, to be less invasive, more acceptable and less expensive than AUS but clear evidence for this is lacking. The MASTER trial aims to determine whether the male synthetic sling is non-inferior to implantation of the AUS for men who have SUI after prostate surgery (for cancer or benign disease), judged primarily on clinical effectiveness but also considering relative harms and cost-effectiveness.Methods/designMen with urodynamic stress incontinence (USI) after prostate surgery, for whom surgery is judged appropriate, are the target population. We aim to recruit men from secondary care urological centres in the UK NHS who carry out surgery for post-prostatectomy incontinence. Outcomes will be assessed by participant-completed questionnaires and 3-day urinary bladder diaries at baseline, 6, 12 and 24 months. The 24-h urinary pad test will be used at baseline as an objective assessment of urine loss. Clinical data will be completed at the time of surgery to provide details of the operative procedures, complications and resource use in hospital. At 12 months, men will also have a clinical review to evaluate the results of surgery (including another 24-h pad test) and to identify problems or need for further treatment.DiscussionA robust examination of the comparative effectiveness of the male synthetic sling will provide high-quality evidence to determine whether or not it should be adopted widely in the NHS.Trial registrationInternational Standard Randomised Controlled Trial Registry: Number ISRCTN49212975 . Registered on 22 July 2013. First patient randomised on 29 January 2014.

Project description:ImportanceAmong women and men with severe obesity, evidence for improvement in urinary incontinence beyond the first year after bariatric surgery-induced weight loss is lacking.ObjectivesTo examine change in urinary incontinence before and after bariatric surgery and to identify factors associated with improvement and remission among women and men in the first 3 years after bariatric surgery.Design, setting, and participantsThe Longitudinal Assessment of Bariatric Surgery 2 is an observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. Participants were recruited between February 21, 2005, and February 17, 2009. Adults undergoing first-time bariatric surgical procedures as part of clinical care by participating surgeons between March 14, 2006, and April 24, 2009, were followed up for 3 years (through October 24, 2012).InterventionParticipants undergoing bariatric surgery completed research assessments before the procedure and annually thereafter.Main outcomes and measuresThe frequency and type of urinary incontinence episodes in the past 3 months were assessed using a validated questionnaire. Prevalent urinary incontinence was defined as at least weekly urinary incontinence episodes, and remission was defined as change from prevalent urinary incontinence at baseline to less than weekly urinary incontinence episodes at follow-up.ResultsOf 2458 participants, 1987 (80.8%) completed baseline and follow-up assessments. At baseline, the median age was 47 years (age range, 18-78 years), the median body mass index was 46 kg/m2 (range, 34-94 kg/m2), and 1565 of 1987 (78.8%) were women. Urinary incontinence was more prevalent among women (49.3%; 95% CI, 46.9%-51.9%) than men (21.8%; 95% CI, 18.2%-26.1%) (P < .001). After a mean 1-year weight loss of 29.5% (95% CI, 29.0%-30.1%) in women and 27.0% (95% CI, 25.9%-28.6%) in men, year 1 urinary incontinence prevalence was significantly lower among women (18.3%; 95% CI, 16.4%-20.4%) and men (9.8%; 95% CI, 7.2%-13.4%) (P < .001 for all). The 3-year prevalence was higher than the 1-year prevalence for both sexes (24.8%; 95% CI, 21.8%-26.5% among women and 12.2%; 95% CI, 9.0%-16.4% among men) but was substantially lower than baseline (P < .001 for all). Weight loss was independently related to urinary incontinence remission (relative risk, 1.08; 95% CI, 1.06-1.10 in women and 1.07; 95% CI, 1.02-1.13 in men) per 5% weight loss, as were younger age and the absence of a severe walking limitation.Conclusions and relevanceAmong women and men with severe obesity, bariatric surgery was associated with substantially reduced urinary incontinence over 3 years. Improvement in urinary incontinence may be an important benefit of bariatric surgery.

Project description:ObjectiveTo compare surgeons' intraoperative surgeon acceptability or assessment of the operative field regarding bowel contents and patients' satisfaction with or without a mechanical bowel preparation before reconstructive vaginal prolapse surgery.MethodsIn this single-blind, randomized trial, women scheduled to undergo vaginal prolapse surgery with a planned apical suspension and posterior colporrhaphy were allocated using block randomization to an intervention or control group. Surgeons were blinded to patient allocation. One day before surgery, mechanical bowel preparation instructions consisted of a clear liquid diet and two self-administered saline enemas; the participants in the control group sustained a regular diet and nothing by mouth after midnight. The primary outcome was surgeons' intraoperative assessment of the surgical field regarding bowel content as measured on a 4-point Likert scale (1, excellent; 4, poor). Secondary outcomes included participant satisfaction and bowel symptoms. The primary outcome was determined by intention-to-treat analysis and other analyses were per protocol.ResultsOf the 150 women randomized (75 women to intervention and control group), 145 completed the study. No differences existed in the demographic, clinical, and intraoperative characteristics between groups (P>.05). Surgeons' intraoperative assessment rating was 85% "excellent or good" with bowel preparation compared with 90% for participants in the control group (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.21-1.61; P=.30). The bowel preparation group was less likely to report "complete" satisfaction compared with the participants in the control group (OR 0.11, 95% CI 0.04-0.35; P<.001). Abdominal fullness and cramping, fatigue, anal irritation, and hunger pains were greater in the bowel preparation group (all P<.01).ConclusionBefore reconstructive vaginal surgery, mechanical bowel preparation conferred no benefit regarding surgeons' intraoperative assessment of the operative field, reflected decreased patient satisfaction, and had increased abdominal symptoms.Clinical trial registrationClinicalTrials.gov, www.clinicaltrials.gov, NCT01431040.Level of evidenceI.

Project description:BackgroundINVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?) was a mixed methods study to assess the feasibility of a future randomised controlled trial of invasive urodynamic testing (IUT) prior to surgery for stress urinary incontinence (SUI) in women. Here we report one of the study's five components, with the specific objectives of (i) exploring the cost-effectiveness of IUT compared with clinical assessment plus non-invasive tests (henceforth described as 'IUT' and 'no IUT' respectively) in women with SUI or stress-predominant mixed urinary incontinence (MUI) prior to surgery, and (ii) determining the expected net gain (ENG) from additional research.MethodsStudy participants were women with SUI or stress-predominant MUI who had failed to respond to conservative treatments recruited from seven UK urogynaecology and female urology units. They were randomised to receive either 'IUT' or 'no IUT' before undergoing further treatment. Data from 218 women were used in the economic analysis. Cost utility, net benefit and value of information (VoI) analyses were performed within a randomised controlled pilot trial. Costs and quality-adjusted life years (QALYs) were estimated over 6 months to determine the incremental cost per QALY of 'IUT' compared to 'no IUT'. Net monetary benefit informed the VoI analysis. The VoI estimated the ENG and optimal sample size for a future definitive trial.ResultsAt 6 months, the mean difference in total average cost was £138 (p?=?0.071) in favour of 'IUT'; there was no difference in QALYs estimated from the SF-12 (difference 0.004; p?=?0.425) and EQ-5D-3L (difference -?0.004; p?=?0.725); therefore, the probability of IUT being cost-effective remains uncertain. The estimated ENG was positive for further research to address this uncertainty with an optimal sample size of 404 women.ConclusionsThis is the largest economic evaluation of IUT. On average, up to 6 months after treatment, 'IUT' may be cost-saving compared to 'no IUT' because of the reduction in surgery following invasive investigation. However, uncertainty remains over the probability of 'IUT' being considered cost-effective, especially in the longer term. The VoI analysis indicated that further research would be of value.Trial registrationISRCTN. ISRCTN71327395. Registered 7 June 2010.

Project description:ImportanceMixed urinary incontinence, including both stress and urgency incontinence, has adverse effects on a woman's quality of life. Studies evaluating treatments to simultaneously improve both components are lacking.ObjectiveTo determine whether combining behavioral and pelvic floor muscle therapy with midurethral sling is more effective than sling alone for improving mixed urinary incontinence symptoms.Design, setting, and participantsRandomized clinical trial involving women 21 years or older with moderate or severe stress and urgency urinary incontinence symptoms for at least 3 months, and at least 1 stress and 1 urgency incontinence episode on a 3-day bladder diary. The trial was conducted across 9 sites in the United States, enrollment between October 2013 and April 2016; final follow-up October 2017.InterventionsBehavioral and pelvic floor muscle therapy (included 1 preoperative and 5 postoperative sessions through 6 months) combined with midurethral sling (n = 209) vs sling alone (n = 207).Main outcomes and measuresThe primary outcome was change between baseline and 12 months in mixed incontinence symptoms measured by the Urogenital Distress Inventory (UDI) long form; range, 0 to 300 points; minimal clinically important difference, 35 points, with higher scores indicating worse symptoms.ResultsAmong 480 women randomized (mean [SD] age, 54.0 years [10.7]), 464 were eligible and 416 (86.7%) had postbaseline outcome data and were included in primary analyses. The UDI score in the combined group significantly decreased from 178.0 points at baseline to 30.7 points at 12 months, adjusted mean change -128.1 points (95% CI, -146.5 to -109.8). The UDI score in the sling-only group significantly decreased from 176.8 to 34.5 points, adjusted mean change -114.7 points (95% CI, -133.3 to -96.2). The model-estimated between-group difference (-13.4 points; 95% CI, -25.9 to -1.0; P = .04) did not meet the minimal clinically important difference threshold. Related and unrelated serious adverse events occurred in 10.2% of the participants (8.7% combined and 11.8% sling only).Conclusions and relevanceAmong women with mixed urinary incontinence, behavioral and pelvic floor muscle therapy combined with midurethral sling surgery compared with surgery alone resulted in a small statistically significant difference in urinary incontinence symptoms at 12 months that did not meet the prespecified threshold for clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT01959347.

Dataset Information

A randomized trial of urodynamic testing before stress-incontinence surgery.

Publications

A randomized trial of urodynamic testing before stress-incontinence surgery.

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