Mobile app-guided pelvic floor rehab vs. in-person rehab for urinary leakage in adult women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized non-inferiority trial compares a smartphone app-based pelvic floor rehabilitation program to standard in-person therapy for women with stress or mixed incontinence predominant to stress. Participants undergo a baseline eligibility check, a supervised training session, then follow one of the two rehabilitation approaches for 3 months, with quality of life questionnaires completed at baseline and at 4 months. The study is conducted at a tertiary hospital in Porto, Portugal, and includes adults who can contract the pelvic floor and meet other safety criteria. The trial aims to see if the app can deliver similar improvements in quality of life as conventional therapy while potentially improving access and adherence.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital de São João
  Porto, Portugal Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 4D Transperineal Ultrasound to Check UVJ Mobility After Vaginal Laser for Stress Incontinence

  This study tests whether three sessions of self-paid vaginal Er:YAG laser treatment change urethrovesical junction mobility in women with stress urinary incontinence.

  Recruiting Charles University, Czech Republic · Prague · NCT07907016

• Educational video before urodynamic testing to see if it lowers anxiety

  This study tests whether watching a short educational video before urodynamics helps reduce anxiety for women undergoing the test.

  Recruiting Meir Medical Center · Kfar Saba, Israel · NCT07740629

• Reliability of pelvic floor measurements from ultrasound during rest and during weightlifting

  This study tests how consistently pelvic floor measurements from ultrasound can be obtained by different people and by the same person across rest and during weightlifting in adults with female anatomy.

  Recruiting at 2 sites University of Ottawa · Langley, British Columbia and 1 other locations · NCT07727460

• Trampoline effects on pelvic support and urine leakage

  This study will try a 10-minute high-intensity trampoline session to see if it causes urine leakage or short-term changes in pelvic floor structure in active women aged 18–40 who do not usually leak.

  Recruiting University of Ottawa · Ottawa, Ontario · NCT07183800

• Assessing tissue elasticity in women with urinary incontinence

  This study is testing a new way to see if the stiffness of tissue around the urethra can help doctors better diagnose stress urinary incontinence in women.

  Recruiting Szeged University · Szeged · NCT06933407

• Using stem cells from fat to treat urinary incontinence in women over 50

  This study is testing if using stem cells from fat can help women over 50 with urinary incontinence feel better compared to a saline solution.

  Recruiting at 5 sites Phase 1 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Coslada, Madrid and 5 other locations · NCT06738576

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.