Group-based pelvic floor muscle training is a more cost-effective approach to treat urinary incontinence in older women: economic analysis of a randomised trial.

QUESTION(S): How cost-effective is group-based pelvic floor muscle training (PFMT) for treating urinary incontinence in older women? DESIGN: Economic evaluation conducted alongside an assessor-blinded, multicentre randomised non-inferiority trial with 1-year follow-up. PARTICIPANTS: A total of 362 women aged ≥ 60 years with stress or mixed urinary incontinence. INTERVENTION: Twelve weekly 1-hour PFMT sessions delivered individually (one physiotherapist per woman) or in groups (one physiotherapist per eight women). OUTCOME MEASURES: Urinary incontinence-related costs per woman were estimated from a participant and provider perspective over 1 year in Canadian dollars, 2019. Effectiveness was based on reduction in leakage episodes and quality-adjusted life years. Incremental cost-effectiveness ratios and net monetary benefit were calculated for each of the effectiveness outcomes and perspectives. RESULTS: Both group-based and individual PFMT were effective in reducing leakage and promoting gains in quality-adjusted life years. Furthermore, group-based PFMT was ≥ 60% less costly than individual treatment, regardless of the perspective studied: -$914 (95% CI -970 to -863) from the participant's perspective and -$509 (95% CI -523 to -496) from the provider's perspective. Differences in effects between study arms were minor and negligible. Adherence to treatment was high, with low loss to follow-up and no between-group differences. CONCLUSION: Compared with standard individual PFMT, group-based PFMT was less costly and as clinically effective and widely accepted. These results indicate that patients and healthcare decision-makers should consider group-based PFMT to be a cost-effective first-line treatment option for urinary incontinence. TRIAL REGISTRATION: ClinicalTrials.govNCT02039830.

Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials.

BACKGROUND: Recruitment of participants is crucial to the success of any trial as it can have a major impact on study costs, the duration of the study itself, and, more critically, trial failure. Given that vulvodynia particularly affects young women, the use of social media and e-recruitment could prove efficient for enrollment. AIM: To compare the efficiency, effectiveness, and cost-effectiveness of three different recruitment methods. METHODS: The comparison data were collected as part of a bicentric randomized controlled trial evaluating the efficacy of physiotherapy in comparison with topical lidocaine in 212 women suffering from provoked vestibulodynia. The recruitment methods included: (i) conventional methods (eg, posters, leaflets, business cards, newspaper ads); (ii) health professional referrals, and (iii) e-recruitment (eg, Facebook ads and web initiatives). Women interested in participating were screened by telephone for eligibility criteria and were assessed by a gynecologist to confirm their diagnosis. Once included, structured interviews were undertaken to describe their baseline characteristics. MAIN OUTCOME MEASURES: The outcomes of this study were the recruitment efficiency (the number of patients screened/enrolled), recruitment effectiveness (the number of participants enrolled), cost-effectiveness (cost per enrolled participant), and retention rate, and baseline characteristics of participants were monitored for each method. RESULTS: The conventional methods (n = 101, 48%) were more effective as they allowed for greater enrollment of participants, followed by e-recruitment (n = 60, 28%) and health professional referrals (n = 33, 16%) (P < 0.007). Recruitment efficiency was found to be similar for e-recruitment and referrals (60/122 and 33/67, 49%, P = 0.055) but lower for conventional methods (101/314, 32%, P < 0.011). Nonsignificant differences were found between the three groups for baseline characteristics (P ≥ 0.189) and retention rate (91%, P ≥ 0.588). The average cost per enrolled participant was fairly similar for e-recruitment ($117) and conventional methods ($110) and lower for referrals ($60). CLINICAL IMPLICATIONS: Our results suggest that having a variety of recruitment methods is beneficial in promoting clinical trial recruitment without affecting participant characteristics and retention rates. STRENGTH & LIMITATIONS: Although recruitment methods were used concomitantly, this study gives an excellent insight into the advantages and limitations of recruitment methods owing to a large sample size. CONCLUSION: The study findings revealed that e-recruitment is a valuable recruitment method because of its comparable efficiency and cost-effectiveness to health professional referrals and conventional methods, respectively. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, number NCT01455350. Benoit-Piau J, Dumoulin C, Carroll MS, et al. Efficiency and Cost: E-Recruitment Is a Promising Method in Gynecological Trials. J Sex Med 2020;17:1304-1311.

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a cochrane systematic review abridged republication.

BACKGROUND: Pelvic floor muscle training is the most commonly used physical therapy treatment for women with urinary incontinence. OBJECTIVES: To assess the effects of Pelvic floor muscle training for women with urinary incontinence in comparison to a control treatment and to summarize relevant economic findings. METHODS: Cochrane Incontinence Group Specialized Register (February 12, 2018). SELECTION CRITERIA: Randomized or quasi-randomized trials in women with stress, urgency or mixed urinary incontinence (symptoms, signs, or urodynamic). DATA COLLECTION AND ANALYSIS: Trials were independently assessed by at least two reviewers authors and subgrouped by urinary incontinence type. Quality of evidence was assessed by adopting the Grading of Recommendations, Assessment, Development and Evaluation approach. RESULTS: The review included thirty-one trials involving 1817 women from 14 countries. Overall, trials were small to moderate size, and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration. Based on data available, we can be confident that Pelvic floor muscle training can cure or improve symptoms of stress and all other types of urinary incontinence. It may reduce the number of leakage episodes and the quantity of leakage, while improving reported symptoms and quality of life. Women were more satisfied with Pelvic floor muscle training, while those in control groups were more likely to seek further treatment. Long-term effectiveness and cost-effectiveness of Pelvic floor muscle training needs to be further researched. CONCLUSIONS: The addition of ten new trials did not change the essential findings of the earlier review, suggesting that Pelvic floor muscle training could be included in first-line conservative management of women with urinary incontinence.

Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women.

BACKGROUND: Pelvic floor muscle training (PFMT) is the most commonly used physical therapy treatment for women with stress urinary incontinence (SUI). It is sometimes also recommended for mixed urinary incontinence (MUI) and, less commonly, urgency urinary incontinence (UUI).This is an update of a Cochrane Review first published in 2001 and last updated in 2014. OBJECTIVES: To assess the effects of PFMT for women with urinary incontinence (UI) in comparison to no treatment, placebo or sham treatments, or other inactive control treatments; and summarise the findings of relevant economic evaluations. SEARCH METHODS: We searched the Cochrane Incontinence Specialised Register (searched 12 February 2018), which contains trials identified from CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, WHO ICTRP, handsearching of journals and conference proceedings, and the reference lists of relevant articles. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in women with SUI, UUI or MUI (based on symptoms, signs or urodynamics). One arm of the trial included PFMT. Another arm was a no treatment, placebo, sham or other inactive control treatment arm. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials for eligibility and risk of bias. We extracted and cross-checked data. A third review author resolved disagreements. We processed data as described in the Cochrane Handbook for Systematic Reviews of Interventions. We subgrouped trials by diagnosis of UI. We undertook formal meta-analysis when appropriate. MAIN RESULTS: The review included 31 trials (10 of which were new for this update) involving 1817 women from 14 countries. Overall, trials were of small-to-moderate size, with follow-ups generally less than 12 months and many were at moderate risk of bias. There was considerable variation in the intervention's content and duration, study populations and outcome measures. There was only one study of women with MUI and only one study with UUI alone, with no data on cure, cure or improvement, or number of episodes of UI for these subgroups.Symptomatic cure of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were eight times more likely to report cure (56% versus 6%; risk ratio (RR) 8.38, 95% confidence interval (CI) 3.68 to 19.07; 4 trials, 165 women; high-quality evidence). For women with any type of UI, PFMT groups were five times more likely to report cure (35% versus 6%; RR 5.34, 95% CI 2.78 to 10.26; 3 trials, 290 women; moderate-quality evidence).Symptomatic cure or improvement of UI at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT groups were six times more likely to report cure or improvement (74% versus 11%; RR 6.33, 95% CI 3.88 to 10.33; 3 trials, 242 women; moderate-quality evidence). For women with any type of UI, PFMT groups were two times more likely to report cure or improvement than women in the control groups (67% versus 29%; RR 2.39, 95% CI 1.64 to 3.47; 2 trials, 166 women; moderate-quality evidence).UI-specific symptoms and quality of life (QoL) at the end of treatment: compared with no treatment or inactive control treatments, women with SUI who were in the PFMT group were more likely to report significant improvement in UI symptoms (7 trials, 376 women; moderate-quality evidence), and to report significant improvement in UI QoL (6 trials, 348 women; low-quality evidence). For any type of UI, women in the PFMT group were more likely to report significant improvement in UI symptoms (1 trial, 121 women; moderate-quality evidence) and to report significant improvement in UI QoL (4 trials, 258 women; moderate-quality evidence). Finally, for women with mixed UI treated with PFMT, there was one small trial (12 women) reporting better QoL.Leakage episodes in 24 hours at the end of treatment: PFMT reduced leakage episodes by one in women with SUI (mean difference (MD) 1.23 lower, 95% CI 1.78 lower to 0.68 lower; 7 trials, 432 women; moderate-quality evidence) and in women with all types of UI (MD 1.00 lower, 95% CI 1.37 lower to 0.64 lower; 4 trials, 349 women; moderate-quality evidence).Leakage on short clinic-based pad tests at the end of treatment: women with SUI in the PFMT groups lost significantly less urine in short (up to one hour) pad tests. The comparison showed considerable heterogeneity but the findings still favoured PFMT when using a random-effects model (MD 9.71 g lower, 95% CI 18.92 lower to 0.50 lower; 4 trials, 185 women; moderate-quality evidence). For women with all types of UI, PFMT groups also reported less urine loss on short pad tests than controls (MD 3.72 g lower, 95% CI 5.46 lower to 1.98 lower; 2 trials, 146 women; moderate-quality evidence).Women in the PFMT group were also more satisfied with treatment and their sexual outcomes were better. Adverse events were rare and, in the two trials that did report any, they were minor. The findings of the review were largely supported by the 'Summary of findings' tables, but most of the evidence was downgraded to moderate on methodological grounds. The exception was 'participant-perceived cure' in women with SUI, which was rated as high quality. AUTHORS' CONCLUSIONS: Based on the data available, we can be confident that PFMT can cure or improve symptoms of SUI and all other types of UI. It may reduce the number of leakage episodes, the quantity of leakage on the short pad tests in the clinic and symptoms on UI-specific symptom questionnaires. The authors of the one economic evaluation identified for the Brief Economic Commentary reported that the cost-effectiveness of PFMT looks promising. The findings of the review suggest that PFMT could be included in first-line conservative management programmes for women with UI. The long-term effectiveness and cost-effectiveness of PFMT needs to be further researched.

Creation and testing of the Geriatric Self-Efficacy Index for Urinary Incontinence.

OBJECTIVES: To report on the content development, construct validity, and reliability testing of the Geriatric Self-Efficacy Index for Urinary Incontinence (GSE-UI). DESIGN: Prospective cohort study. SETTING: Six UI outpatient clinics in Quebec, Canada. PARTICIPANTS: Community-dwelling incontinent men and women aged 65 and older. MEASUREMENTS: Thirty-eight items were generated using a literature search and interdisciplinary panel of experts. Item reduction was achieved through field-testing with 75 older men and women with UI attending an information session. The final 20-item draft, measuring older adults' level of confidence in preventing urine loss, was administered to a new group of consecutive patients 1 week before and at the time of their first visit to the UI clinic to enable evaluation of test-retest reliability. A 3-day voiding diary, quantifying the frequency of UI, and the Incontinence Quality of Life questionnaire were used to test construct validity. RESULTS: One hundred sixteen of 300 eligible patients (39%) participated (mean age+/-standard deviation 74+/-6, range 65-87). The GSE-UI items showed normal distributions and no ceiling effects. Self-efficacy scores ranged from 16 to 193 (mean 104+/-41, possible range 0-200) and correlated positively with quality of life scores (r=0.7, P<.001) and negatively with UI severity (r=-0.4, P<.001). Internal consistency for the GSE-UI was 0.94 (Cronbach alpha). Initial test-retest reliability of the 20 items using intraclass correlations ranged from 0.50 to 0.86. CONCLUSION: The GSE-UI will enable measurement of whether a person's confidence in their ability to prevent urine loss is an important mechanism contributing to improvements in UI.

Urinary incontinence after stroke: identification, assessment, and intervention by rehabilitation professionals in Canada.

BACKGROUND AND PURPOSE: Urinary incontinence (UI) is a common and distressing problem after stroke. Although there is evidence of new, effective UI poststroke rehabilitation intervention, it is unknown whether occupational therapists (OTs)' and physical therapists (PTs)' actual practices reflect best practices. We sought to determine the extent to which OTs and PTs identify, assess, and treat UI after stroke and to identify personal and organizational predictors of UI problem identification, best-practice assessment, and intervention. METHODS: Six hundred sixty-three OTs (93% participation rate) and 656 PTs (87% participation rate) working in stroke rehabilitation in Canada were randomly selected and interviewed with a telephone-administered questionnaire. Each responded to a series of open-ended questions related to a generated case (vignette) of a typical client with stroke who was experiencing UI. RESULTS: Only 39% of OTs and 41% of PTs identified UI after stroke as a problem. Fewer than 20% of OTs and 15% of PTs used best-practice assessments, and only 2% of OTs and 3% of PTs used best-practice interventions. Working in Ontario, having allocated learning time, and doing university teaching were among the variables explaining between 6% and 9% of the variability in UI identification and assessment. CONCLUSIONS: Canadian OTs and PTs do not routinely identify poststroke UI as a problem, and best-practice assessments and interventions are underused.