Status:
RECRUITING
Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction
Lead Sponsor:
University of Sao Paulo
Conditions:
Urinary Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Pelvic floor muscle training (PFMT) is the first line treatment of urinary incontinence (UI), anal incontinence (AI) and mild/moderate pelvic organ prolapse (POP) in women. However, 25 to 40% of women...
Detailed Description
Randomised, parallel (two arm), trial comparing biofeedback (experimental arm) versus vaginal palpation (active control, i.e. usual practice) to achieve a correct voluntary pelvic floor muscle contrac...
Eligibility Criteria
Inclusion
- Women aged 18 or over;
- Women referred to the physiotherapeutic treatment of the Lucy Montoro Rehabilitation Center (Ribeirão Preto Medical School) or the Women's Health Reference Center (MATER) for any pelvic floor dysfunction;
- Women unable to perform a PFM contraction (i.e. PFM function classified as 0 or 1 according to the modified oxford scale);
- Women with urinary incontinence (i.e ICIQ-UI-SF score ≥ 3)
- Agree to participate in the research by signing the informed consent form
- It will not be included in this study:
- Women whose pelvic floor dysfunction has an associated neuropathy;
- Women with vaginal or urological symptoms of possible infections;
- Women with pelvic organs prolapse that makes it impossible to evaluate or conduct treatment (stage \> 2 according to Baden-Walker Scale);
- Pregnant women;
- Women with cognitive impairment.
Exclusion
- Women who become pregnant while conducting the study
- Women with intolerance or pain that prevents the conduct of research protocols.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05194137
Start Date
May 1 2022
End Date
July 1 2026
Last Update
August 22 2025
Active Locations (1)
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1
Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil, 14026-596