Mobile App vs. In-Person Pelvic Floor Rehabilitation for Urinary Leakage 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

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence , Stress
• Intervention / Treatment: Other: Mobile app based rehabilitation protocol; Other: Presential rehabilitation program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susana A Moreira, PMR specialist; Phone Number: +351917210578; Email: s.moreira@ulssjoao.min-saude.pt

Study Locations

• Portugal
  • Porto, Portugal, 4200-319
    • Recruiting
    • Hospital de Sao Joao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age >18 years
• stress urinary incontinence (SUI) or mixed urinary incontinence with predominance of SUI
• more than one urinary incontinence episode for week in the last month
• pelvic floor muscle strength equal or greater than 2 assessed by Oxford Modified Rating Score

Exclusion Criteria:

• indwelling urinary catheter
• active pelvic neoplasia
• pelvic organ prolapse grade greater than or equal to 2
• active urinary tract infection or macroscopic hematuria
• neurogenic dysfunction of the lower urinary tract
• cognitive deficit, osteoarticular, neurological or psychiatric pathologies that prevent the realization of the therapeutic program
• conservative or surgical treatment of UI in the last 12 months
• pregnancy or recent childbirth (< 6 months)
• impossibility of access or illiteracy to technological means (smartphone)
• unavailability to attend the supervised program due to accessibility, schedule or economic reasons

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hybrid; mobile app based treatment	Other: Mobile app based rehabilitation protocol; Mobile app based rehabilitation protocol for Stress and Mixed Urinary Incontinence in Adult Women
Active Comparator: conventional; presential	Other: Presential rehabilitation program; Presential rehabilitation program for Stress and Mixed Urinary Incontinence in Adult Women

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UI-related quality of life	UI-related quality of life using the Portuguese version of the King´s Health Questionnaire (KHQ). KHQ is a disease-specific, self-administered questionnaire designed to assess the impact of UI on quality of life in women. The responses in KHQ have a four point rating system. The eight subscales ("domains") score between 0 (best) and 100 (worst). The Symptom Severity scale is scored from 0 (best) to 30 (worst). Decreases in KHQ domain scores indicate an improvement in quality of life. The minimally important difference - the smallest change in score that subjects perceive as beneficial - is 3 points for the symptom severity scale and 5 points for all other KHQ domains.	At baseline and in16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
UI severity	UI severity using: the ICS pad test, the Portuguese versions of the ICIQ-bladder diary, and of the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). The ICS pad test has been standardized by the International Continence Society and implies drinking 500mL of water and performing a protocol of activities during 1 hour. The total amount of urine leaked is determined by weighing the pad at the end. A weight difference of 1g is considered as significative. The ICIQ-bladder diary is a standardised diary that includes records of the number of incontinence episodes. The ICIQ-UI Short Form is a self-administered questionnaire for evaluating the frequency, severity and impact on quality of life of UI. It contains 4 items: frequency of urinary incontinence; amount of leakage; overall impact of urinary incontinence; self-diagnostic item. It is scored from 0 (best) to 21 (worst), considering 2.5 points for a minimal clinically important difference.	At baseline and in16 weeks
Perception of change	Perception of change by the patient using the Portuguese version of the Patient Global Impression of Change (PGIC) Scale. The PGIC Scale is is a global index that may be used to rate the response of a condition to a therapy. It is a transition scale consisting of a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse).	At baseline and in16 weeks
Sexual function	Sexual function using the Portuguese version of the Female Sexual Functioning Index (FSFI). The FSFI is a survey measuring the sexual functioning of women over the previous 30 days in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. Sexual disfunction severity is classified into five categories based on FSFI total scores: severe (2-7.2), moderate (7.3-14.4), mild to moderate (14.5-21.6), mild (21.7-28.1 "cutoff value"), and no sexual disfunction (28.2-36).	At baseline and in16 weeks
Symptoms of depression/anxiety	Symptoms of depression/anxiety using the Portuguese version of the Hospital Anxiety & Depression Scale (HADS) questionnaire. HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.	At baseline and in 16 weeks
Health related quality of life	Health related quality of life, using the Portuguese version of the EuroQol 5-Dimension 5-level (EQ-5D-5L) questionnaire. The EQ-5D-5L is a brief, generic, health status measure composed of 5 questions with Likert response options (descriptive system) and a visual analog scale (EQ-VAS). The latter asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively). The VAS can be used as a quantitative measure of health outcome that reflects the patient's own judgement. EQ-5D utility values can be used to calculate QALYs, which can then be used in cost-utility analysis.	At baseline and in 16 weeks
Satisfaction and adherence to treatment .	Satisfaction and adherence to treatment using a 9-point Likert scale and the self-reported number of performed sessions registered in the app (intervention group) and reported by the therapist (control group).	At 16 weeks
Participants assessment of the app quality	Participants assessment of the app quality using the Portuguese version of the User Mobile App Rating Scale (uMARS). The uMARS provides 20 items in a total of 5 subscales, 4 objective quality subscales - Engagement, Functionality, Aesthetics and Information Quality - and 1 subjective quality subscale that adds 6 items to measure the impact perceived by users of the evaluated application. All items are rated on a 5-point scale from "1. Inadequate" to "5. Excellent"; there is an option to select "N/A" if the application component is irrelevant. The quality score is calculated as follows: App Quality Mean Score = (A+B+C+D)/4, where A: Engagement Mean Score; B: Functionality Mean Score; C: Aesthetics Mean Score; D: Information Mean Score. Questions rated "N/A" are excluded from the mean score calculation. Total mean score reflects the overall app quality, higher scores indicate a better user experience.	16 weeks
Direct costs of urinary incontinence	Direct costs of urinary incontinence with an adapted version of the Dowell-Bryant Incontinence Cost Index (DBICI). The DBICI gives a detailed measure of the direct economic costs of urinary incontinence in ambulatory home-dwelling women, with the construct validity confirmed by the significant correlation with other quantitative measures of incontinence. By substituting local prices into the test format, the index can be used in different countries.	At baseline and in16 weeks

Collaborators and Investigators

• Sponsor: Unidade Local de Saúde São João

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: urinary incontinence; mobile app; woman
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence; Urinary Incontinence, Stress
• Other Study ID Numbers: CE-218-2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No