Dataset Information

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

ABSTRACT: There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence-related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed.This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence.ClinicalTrials.gov Identifier: NCT01924728. Date of Registration: 14 August 2013.

SUBMITTER: Lim R

PROVIDER: S-EPMC4477591 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

Lim Renly R Liong Men Long ML Leong Wing Seng WS Khan Nurzalina Abdul Karim NA Yuen Kah Hay KH

Trials 20150621

<h4>Background</h4>There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.<h4>Methods/design</h4>One hundred twenty subjects with stress urinary incont ...[more]

PMID: 26093910

Similar Datasets

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.

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.

Dataset Information

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

Publications

Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets