Randomized Controlled Non-Inferiority Trial Comparing a Mobile Application Based Program With Conventional Rehabilitation for Stress and Mixed Urinary Incontinence in Adult Women
Randomized Controlled Non-Inferiority Trial Comparing a Mobile Application Based Program With Conventional Rehabilitation for Stress and Mixed Urinary Incontinence in Adult Women
The goal of this clinical trial is to learn if a mobile app-guided pelvic floor rehabilitation program works as well as standard in-person pelvic floor rehabilitation to treat urinary leakage in adult women.
The main question it aims to answer is:
Does the app program improve quality of life related to urinary leakage as much as in-person rehabilitation?
Researchers will compare the app-based program to in-person rehabilitation to see if both lead to similar improvements in quality of life.
Participants will:
Attend one medical visit before starting to confirm they are eligible Attend one in-person training session with a physiotherapist Follow either an app-based or an in-person pelvic floor rehabilitation program for 3 months Complete quality of life questionnaires at the start and at 4 months
Background
Urinary incontinence (UI) is common in women and undertreated in Portugal. Only 11% of Portuguese women with UI report having completed any rehabilitation program. Conventional pelvic floor rehabilitation requires supervised sessions two to three times per week for at least 3 to 4 months, mostly available only at tertiary hospitals. Mobile app-based programs may improve access, adherence, and convenience. However, no randomized trial has compared an app-based program directly against supervised rehabilitation as an active comparator in the Portuguese population. An important consideration in participant selection is pelvic floor muscle function. Studies show that up to 53% of women with UI cannot contract the pelvic floor correctly without prior in-person training. For this reason, the ability to voluntarily contract the pelvic floor is an inclusion criterion, confirmed at the baseline medical visit.
Study Design
This is a randomized controlled non-inferiority trial with two parallel arms conducted at the Pelvic Floor Rehabilitation Unit of the Physical and Rehabilitation Medicine (PM&R) Department of ULS São João, a tertiary academic hospital in Porto, Portugal.
The Mobile App
The app-based program was developed by the investigators in collaboration with the Information Systems and Technologies Department and the Data Intelligence Department of ULS São João. It was integrated into the existing My São João App, a platform already in use by patients of the hospital. Prior to the trial, a preliminary version was tested over one month with 10 women with prior experience in supervised pelvic floor rehabilitation and with 4 clinicians specialised in pelvic floor rehabilitation. Participants completed a structured questionnaire assessing interface usability, aesthetics, engagement, and functionality, and took part in a discussion of weaknesses and suggestions for improvement. A final version was developed based on this feedback.
Randomization
After baseline assessment, participants are randomized 1:1 into the intervention or control group by a research assistant not involved in the investigation. Allocation uses a computer-generated random sequence implemented through sequentially numbered sealed opaque envelopes, stored in a locked cabinet accessible only to the research assistant. Envelopes are opened immediately before the initial individual session. Participants and health professionals are not blinded to group allocation.
Intervention Group - App-Based Program (12 weeks)
One in-person medical consultation at the start. Participants install the app, are trained on its use, and receive lifestyle and behavioural recommendations tailored to their UI type and baseline assessment results. Three in-person individual physiotherapy sessions at weeks 0, 4, and 8. At each session, participants are trained on the exercises that will be released on the app following that session. App content includes a structured pelvic floor muscle exercise program released in 3 progressive phases, with gradual increases in duration, repetitions, and positions. Participants perform a daily sequence 3 times per day and two 30-minute sessions per week. Programmable reminders allow participants to set exercise times according to their own schedule. Daily app notifications collect feedback on the number of sessions completed and participant satisfaction. One teleconsultation at week 6 to assess adherence, motivation, side effects, and progress. At week 12, participants are notified via the app to begin the maintenance phase: the daily sequence 3 times per day, 3 days per week. One in-person medical consultation at week 16 to assess compliance and outcomes.
Control Group - Supervised Program (12 weeks)
One in-person medical consultation at the start. Participants receive lifestyle and behavioural recommendations tailored to their UI type and baseline assessment results, and a written leaflet with a pelvic floor exercise sequence to perform 3 times per day. One initial in-person individual physiotherapy session, followed by supervised face-to-face group sessions twice per week (30 minutes each), structured in 3 progressive phases matching those of the app program. One in-person medical consultation at week 6 to assess adherence, side effects, and progress. At week 12, participants are instructed to begin the maintenance phase: 3 exercise sets, 3 days per week. One in-person medical consultation at week 16 to reassess compliance and outcomes.
Assessment Schedule
Outcomes are collected by physiatrists specialised in pelvic floor rehabilitation using a digital data collection form at three time points: baseline (week 0), mid-program (week 6), and end of follow-up (week 16).
Sample Size
Sample size was calculated using WinPepi version 11.65, assuming a significance level of 5%, statistical power of 80%, and a 1:1 allocation ratio. Based on a non-inferiority margin of 10.24 points on the King's Health Questionnaire (KHQ), with standard deviations of 10.545 (intervention) and 6.23 (control), 24 participants are required (12 per group). Accounting for an estimated 33% dropout rate, the target sample is 32 participants.
Statistical Analysis
Continuous variables will be described as means with standard deviations, or medians with interquartile ranges, depending on distribution. Categorical variables will be presented as proportions. Between-group comparisons at end of program will use the independent-samples t-test for normally distributed data, or the Mann-Whitney test otherwise. Categorical variables will be compared using the Chi-square or Fisher's exact test as appropriate. A pre-specified subgroup analysis will examine adherence and clinical improvement according to age, primary diagnosis (SUI or MUI), prior treatments, condition severity, quality of life scores, marital status, educational level, profession, smartphone operating system, duration of smartphone ownership, daily hours of use, and prior experience with health-related apps. A subsequent cost-effectiveness analysis is planned.
Ethical Considerations
The study is conducted in accordance with the ethical principles of the 1964 Declaration of Helsinki and its subsequent amendments. Participation is voluntary. Eligible participants are approached at their first consultation and given a participant information sheet and written informed consent form to take home. Signed consent is confirmed at the second appointment, two weeks later. Participants may withdraw at any time without consequence. All data are anonymised prior to analysis and stored securely with password protection. Only the participant's physiatrist has access to medical records. Results will be disseminated at scientific conferences and in peer-reviewed journals.
Inclusion Criteria:
Exclusion Criteria:
s.moreira@ulssjoao.min-saude.pt+351917210578