Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction

Recruiting now · Not applicable

Conditions studied: Urinary Incontinence

In brief

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 with pelvic floor dysfunction symptoms are unable to voluntarily contract their pelvic floor muscle (PFM) and PFM proprioception of this population is specially reduced. Literature is scarce about methods to facilitate a voluntary PFM contraction and improve PFM proprioception therefore, a specific protocol structured to teach PFM contraction is needed. The use of biofeedback could facilitate women´s capacity to voluntary contract their PFM.

Key facts

Study ID

NCT05194137

Run by

University of Sao Paulo

People needed

100

Starts

2022-05-01

Expected to finish

2026-07-01

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Women who become pregnant while conducting the study
• Women with intolerance or pain that prevents the conduct of research protocols.

Where it is running

• Universidade de São Paulo — Ribeirão Preto, São Paulo, Brazil (enrolling)

Full record on ClinicalTrials.gov

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