Usability, Acceptability and Effect of a Mobile Application and Connected Object for Older Women With UI

NCT07427693 | Active Not Recruiting

• 2 other identifiers: CER VN 24-25-36CIHR_191336
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to evaluate the usability, acceptability, and impact of the Oups! mobile app and a connected Bluetooth dynamometer for at-home PFM training to treat UI. The study will:

1. 1.assess usability and participant feedback on the Oups! app, identifying improvements;
2. 2.evaluate the usability and acceptability of the dynamometer during assessment and home practice, noting potential enhancements; and
3. 3.measure the effects of the app and device on UI symptoms, quality of life, and PFM function post-treatment.

Conditions

Telehealth; Urinary Incontinence (UI); Urinary Stress Incontinence

Keywords

female; aging; physiotherapy; pelvic floor; rehabilitation; mobile app; connected device

Outcome Measures

Primary Outcomes (1)

• Percent change in the number of UI episodes

  evaluated with a 7-day bladder diary

  at recruitment and 13 weeks after recruitment

Secondary Outcomes (12)

• Change in the symptoms and the degree to which UI-associated symptoms are troubling or bothersome

  at recruitment and 13 weeks after recruitment

• Change in UI related QOL

  at recruitment and 13 weeks after recruitment

• Change in PFM function: PERFECT Score

  at recruitment and 13 weeks after recruitment

• Change in PFM Function: Montreal Dynamometer

  at recruitment and 13 weeks after recruitment

• Change in Pelvic Floor Muscle Function: Connected Device

  at recruitment and 13 weeks after recruitment

Other Outcomes (3)

• Validation of the FC uMARS

  13 weeks after recruitment

• Usability of the connected device

  at recruitment and 13 weeks after recruitment

• Validation of the connected object

  at recruitment and 13 weeks after recruitment

Study Arms (1)

Physiotherapy through mobile app and connected device

EXPERIMENTAL

PFMT using the Oups! mobile app + a connected vaginal device for 12 weeks

Behavioral: Physiotherapy through mobile app and connected device

Interventions

Physiotherapy through mobile app and connected device BEHAVIORAL

Multimodal physiotherapy through the Oups! mobile app and connected device including pelvic floor muscle exercises 5x/week, an educational video 1x/week, and a motivational video 1x/week. The connected device allows instant feedback about the quality of their contractions and adjusts the goals for each exercise.

Physiotherapy through mobile app and connected device

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• years +
• Stress or mixed UI symptoms with predominantly stress UI symptoms
• At least 3 or more urinary leaks/week
• Able to ambulate safely
• Understand simple instruction in French, written and verbally
• Basic understanding of how to use a tablet or mobile phone
• Willing to participate in a gynecological exam
• Able to properly contract the PFM
• Provide informed consent.

You may not qualify if:

• Urge UI symptoms or mixed incontinence with primarily urgency
• Neurological condition
• Grade 3 or 4 of pelvic organ prolapse (POP)
• Any other acute or chronic condition likely to interfere with the mobile app and/or connected object
• Risk factors likely to interfere with the mobile app and/or connected object (i.e.: chronic constipation, chronic cough)
• Medications that can interfere with the mobile app and/or connected object
• Received UI treatments in the last year.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (1)

Women's Health and Aging Laboratory - CRIUGM

Montreal, Quebec, H3W 1W4, Canada

Location

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

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

Study Officials

• Chantale Dumoulin, Ph.D.

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Chantal Dumoulin, researcher and laboratory director

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 23, 2026
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)