Dataset Information

Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial.

ABSTRACT: OBJECTIVE:To evaluate the effects of Mind Over Matter: Healthy Bowels, Healthy Bladder, a small-group intervention, on urinary and bowel incontinence symptoms among older women with incontinence. METHODS:In this individually randomized group treatment trial, women aged 50 years and older with urinary, bowel incontinence, or both, were randomly allocated at baseline to participate in Mind Over Matter: Healthy Bowels, Healthy Bladder immediately (treatment group) or after final data collection (waitlist control group). The primary outcome was urinary incontinence (UI) improvement on the Patient Global Impression of Improvement at 4 months. Validated instruments assessed incontinence, self-efficacy, depression, and barriers to care-seeking. Intent-to-treat analyses compared differences between groups. Target sample size, based on an anticipated improvement rate of 45% in treated women vs 11% in the control group, 90% power, type I error of 0.05, with anticipated attrition of 25%, was 110. RESULTS:Among 121 women randomized (62 treatment group; 59 control group), 116 (95%) completed the 4-month assessment. Most participants were non-Hispanic white (97%), with a mean age of 75 years (SD 9.2, range 51-98); 66% had attended some college. There were no significant between-group differences at baseline. At 4 months, 71% of treated women vs 23% of women in the control group reported improved UI on Patient Global Impression of Improvement (P<.001); 39% vs 5% were much improved (P<.001). Regarding bowel incontinence, 55% of treated women vs 27% of women in the control group improved on Patient Global Impression of Improvement (P<.005), with 35% vs 11% reporting much improvement (P<.005). Treated women improved significantly more than women in the control group on all validated instruments of incontinence severity, quality of life, and self-efficacy. Care-seeking rates were similar between groups. CONCLUSION:Participation in a small-group intervention improves symptoms of both urinary and bowel incontinence in older women. Mind Over Matter is a feasible model with potential to bring effective behavioral solutions to the community. CLINICAL TRIAL REGISTRATION:ClinicalTrials.gov, NCT03140852.

SUBMITTER: Brown HW

PROVIDER: S-EPMC6732187 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial.

Brown Heidi W HW Braun Emilie J EJ Wise Meg E ME Myers Shannon S Li Zhanhai Z Sampene Emmanuel E Jansen Sierra M SM Moberg D Paul DP Mahoney Jane E JE Rogers Rebecca G RG

Obstetrics and gynecology 20190901 3

<h4>Objective</h4>To evaluate the effects of Mind Over Matter: Healthy Bowels, Healthy Bladder, a small-group intervention, on urinary and bowel incontinence symptoms among older women with incontinence.<h4>Methods</h4>In this individually randomized group treatment trial, women aged 50 years and older with urinary, bowel incontinence, or both, were randomly allocated at baseline to participate in Mind Over Matter: Healthy Bowels, Healthy Bladder immediately (treatment group) or after final data ...[more]

PMID: 31403596

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Project description:ObjectiveTo evaluate whether pelvic floor muscle training using a motion-based digital intravaginal device is more effective than home pelvic floor muscle training for treatment of stress or stress-predominant mixed urinary incontinence (UI).MethodsIn a remote, virtually executed 8-week prospective randomized controlled superiority trial, women with stress or stress-predominant mixed UI were randomized to pelvic floor muscle training using a motion-based digital therapeutic device or a home training program using written and narrated instructions. Primary outcomes were change in UDI-6 (Urogenital Distress Inventory, Short Form) score and stress urinary incontinence (SUI) episodes on a 3-day bladder diary. A sample size of 139 per group (n=278) was planned to meet the power analysis requirements for the UDI-6 score (n=278) and the bladder diary (n=78). Prespecified secondary outcomes included quality-of-life surveys and adherence reporting.ResultsFrom September 2020 to March 2021, 5,353 participants were screened, and 363 were randomized: 182 in the intervention and 181 in the control group. There were no baseline clinicodemographic differences between groups. The mean change in UDI-6 score was significantly greater for the intervention group compared with the control group (18.8 vs 14.7, P=.01). The median (interquartile range) number of SUI episodes on the 3-day bladder diary was significantly reduced from 5 (3-8) and 5 (3-8) episodes to 1 (0-3) and 2 (1-4) (P=.005) in the intervention group compared with control group, respectively. A significantly greater number of participants in the intervention group than in the control group reported they were "much improved" or "very much improved" on the PGI-I (Patient Global Impression of Improvement) (63/143 [44.1% vs 45/156 [28.8%], odds ratio 1.94, 95% CI 1.21-3.15). There were no device-related severe adverse events.ConclusionIn this all-remote, virtually conducted trial, pelvic floor muscle training guided by a motion-based digital therapeutic device resulted in significantly improved UI symptoms and reduction of UI episodes compared with a home training program.Clinical trial registrationClinicalTrials.gov, NCT04508153.Funding sourceRenovia Inc.

Project description:Urinary incontinence (UI), one of the most prevalent health concerns confronting women aged over 60 years, affects up to 55% of older community-dwelling women-20-25% with severe symptoms. Clinical practice guidelines recommend individualized pelvic floor muscle training (PFMT) as a first-line treatment for stress or mixed UI in women, although lack of human and financial resources limits delivery of this first-line treatment. Preliminary data suggest that group-based treatments may provide the answer. To date, no adequately powered trials have evaluated the effectiveness or cost-effectiveness of group compared to individual PFMT for UI in older women. Given demographic projections, high prevalence of UI in older women, costly barriers, and group PFMT promising results, there is a clear need to rigorously compare the short- and long-term effectiveness and cost-effectiveness of group vs individual PFMT.The study is designed as a non-inferiority randomized controlled trial, conducted in two facilities (Montreal and Sherbrooke) in the Canadian province of Quebec. Participants include 364 ambulatory, community-dwelling women, aged 60 years and older, with stress or mixed UI. Randomly assigned participants will follow a 12-week PFMT, either in one-on-one sessions or as part of a group, under the supervision of a physiotherapist. Blinded assessments at baseline, immediately post intervention, and at one year will include the seven-day bladder diary, the 24-h pad test, symptoms and quality of life questionnaires, adherence and self-efficacy questionnaire, pelvic floor muscle function, and cost assessments. Primary analysis will test our main hypothesis that group-based treatment is not inferior to individualized treatment with respect to the primary outcome: relative (%) reduction in the number of leakages.Should this study find that a group-based approach is not less effective than individual PFMT, and more cost-effective, this trial will impact positively continence-care accessibility and warrant a change in clinical practice.ClinicalTrials.gov, NCT02039830 . Registered on 12 December 2013; Study protocol version 2; 21 November 2013.

Project description:Importance:Urinary incontinence (UI) guidelines recommend behavioral interventions as first-line treatment using individualized approaches. A one-time, group-administered behavioral treatment (GBT) could enhance access to behavioral treatment. Objective:To compare the effectiveness, cost, and cost-effectiveness of GBT with no treatment for UI in older women. Design, Setting, and Participants:Multisite randomized clinical trial (the Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms [GLADIOLUS] study), conducted from July 7, 2014, to December 31, 2016. The setting was outpatient practices at 3 academic medical centers. Community-dwelling women 55 years or older with UI were recruited by mail and screened for eligibility, including a score of 3 or higher on the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), symptoms of at least 3 months' duration, and absence of medical conditions or treatments that could affect continence status. Of 2171 mail respondents, 1125 were invited for clinical screening; 463 were eligible and randomized; 398 completed the 12-month study. Interventions:The GBT group received a one-time 2-hour bladder health class, supported by written materials and an audio CD. Main Outcomes and Measures:Outcomes were measured at in-person visits (at 3 and 12 months) and by mail or telephone (at 6 and 9 months). The primary outcome was the change in the ICIQ-SF score. Secondary outcome measures assessed UI severity, quality of life, perceptions of improvement, pelvic floor muscle strength, and costs. Evaluators were masked to group assignment. Results:Participants (232 in the GBT group and 231 in the control group) were aged 55 to 91 years (mean [SD] age, 64 [7] years), and 46.2% (214 of 463) were African American. In intent-to-treat analyses, the ICIQ-SF scores for GBT were consistently lower than control across all time points but did not achieve the projected 3-point difference. At 3 months, the difference in differences was 0.96 points (95% CI, -1.51 to -0.41 points), which was statistically significant but clinically modest. The mean (SE) treatment effects at 6, 9, and 12 months were 1.36 (0.32), 2.13 (0.33), and 1.77 (0.31), respectively. Significant group differences were found at all time points in favor of GBT on all secondary outcomes except pelvic floor muscle strength. The incremental cost to achieve a treatment success was $723 at 3 months; GBT dominated at 12 months. Conclusions and Relevance:The GLADIOLUS study shows that a novel one-time GBT program is modestly effective and cost-effective for reducing UI frequency, severity, and bother and improving quality of life. Group-administered behavioral treatment is a promising first-line approach to enhancing access to noninvasive behavioral treatment for older women with UI. Trial Registration:ClinicalTrials.gov identifier: NCT02001714.

Project description:BackgroundAcupuncture is a potential conservative therapy for women with stress urinary incontinence (SUI). There is limited evidence to support its effectiveness due to the poor quality of existing studies.MethodsWe performed a pilot randomized, controlled trial to preliminarily assess the efficacy of electroacupuncture (EA) in women with pure SUI. A total of 80 women with pure SUI were randomly assigned to receive EA with deep needling at BL33 and BL35 (n = 40) or sham EA with non-penetrating needling at sham acupoints (n = 40) three sessions per week for 6 weeks. The women were followed for 24 weeks. The primary outcome was the change from baseline in the amount of urine leakage measured by a 1-hour pad test after 6 weeks. The secondary outcomes included the 72-hour incontinence episode frequency (IEF), International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) score, and patient self-evaluation of therapeutic effect. Adverse events (AEs) were monitored throughout the trial.ResultsThe median decrease from baseline of urine leakage measured by the 1-hour pad test was 2.5 g [interquartile range (IQR): 1.80-14.6 in the EA group, which was greater than the median decrease of 0.05 g (IQR: -2.80-+0.50) in the sham EA group after 6 weeks (p<0.01). The differences between groups in the decrease from baseline of 72-hour IEF became statistically significant at week 30 with a median decrease of 3.25 g (IQR: 1.25-5.69) in the EA group, and a median decrease of 1.00 g (IQR: -0.69-+2.88) in the sham EA group (p = 0.01). The participants in the EA group showed greater decreases in ICIQ-SF score and higher ratings in the help they received from the treatment than those in the sham EA group at weeks 6,18 and 30 (all p<0.05). No obvious AEs were observed in either group.ConclusionEA may effectively and safely relieve urinary incontinence symptoms and improve quality of life in women with pure SUI. EA demonstrated more than a placebo effect. Since this is a pilot study, results should be interpreted with caution.Trial registrationClinicalTrials.gov NCT02445573.

Dataset Information

Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial.

Publications

Small-Group, Community-Member Intervention for Urinary and Bowel Incontinence: A Randomized Controlled Trial.

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