Randomized Controlled Non-Inferiority Trial Comparing a Mobile Application Based Program With Conventional Rehabilitation for Stress and Mixed Urinary Incontinence in Adult Women

NCT07597174 | Recruiting

• 1 other identifier: CE-218-2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

ABSTRACT Introduction: Urinary incontinence affects 6,3% to 40,8% of Portuguese women, increasing with age. Pelvic floor rehabilitation including supervised treatments for 3 to 4 months has success rates of 60% to 75%, but it is seldom available and it can be inconvenient and time consuming. mHealth solutions may increase accessibility, adherence and convenience of care. Aims: The aim of this study is to evaluate if an mobile application based rehabilitation program is not inferior to a conventional supervised rehabilitation program in the treatment of adult women with stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) with predominance of SUI. Material and Methods: We will conduct a randomized controlled non-inferiority trial, with two parallel arms, in the Physical and Rehabilitation Medicine Department of the ULS São João, a tertiary academic hospital in Portugal. Women consecutively referred for conservative treatment of urinary incontinence will be considered for eligibility. A sample of 32 participants was calculated as adequate. Before initiating the 3 months program, participants will be evaluated in a medical consult were inclusion criteria, namely capability of contracting voluntarily the pelvic floor, will be assed; and one supervised individual training session with a physiotherapist. The intervention group will complete the program based in an app that will contain lifestyle and behavioural recommendations according the type of urinary incontinence, and pelvic floor muscle exercises - a sequence to be performed three times a day and two weekly 30 minutes sessions that will be sequentially released. Control group will complete a supervised program. Results will be assessed at 4 months. The primary outcome will be urinary incontinence-related quality of life using the Portuguese version of the King´s Health Questionnaire. Discussion and expected results: We expect that the application-based program will prove to be an effective alternative in the treatment of urinary incontinence in selected women. In a posterior analysis, we intend to investigate the cost-effectiveness of the protocol.

Conditions

Urinary Incontinence , Stress

Keywords

mobile app, urinary incontinence, woman

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• UI severity

  At baseline and in16 weeks

• Perception of change

  At baseline and in16 weeks

• Sexual function

  At baseline and in16 weeks

• Symptoms of depression/anxiety

  At baseline and in 16 weeks

• Health related quality of life

  At baseline and in 16 weeks

Study Arms (2)

Hybrid

EXPERIMENTAL

mobile app based treatment

Other: Mobile app based rehabilitation protocol

conventional

ACTIVE COMPARATOR

presential

Other: Presential rehabilitation program

Interventions

Mobile app based rehabilitation protocol OTHER

Mobile app based rehabilitation protocol for Stress and Mixed Urinary Incontinence in Adult Women

Hybrid

Presential rehabilitation program OTHER

Presential rehabilitation program for Stress and Mixed Urinary Incontinence in Adult Women

conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidade Local de Saúde São João: lead

Study Sites (1)

Hospital de São João

Porto, 4200-319, Portugal

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Susana A Moreira, PMR specialist

CONTACT

+351917210578; s.moreira@ulssjoao.min-saude.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: randomized controlled non-inferiority trial with two parallel arms

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 19, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

PT (1)