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

NCT07597174 | Recruiting

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

Brief Summary

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

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: Principal investigator

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 22, 2026

Record last verified: 2026-05

Locations

PT (1)