Biofeedback versus vaginal palpation to teach voluntary pelvic floor muscle contractions

Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction to Women Incapable of Performing it? A Non-inferiority Randomized Controled Trial

This test compares biofeedback and vaginal palpation to see which better helps women with urinary incontinence who cannot currently contract their pelvic floor muscles learn a correct contraction.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Sao Paulo (Academic / other)
• Locations: 1 site (Ribeirão Preto, São Paulo)
• Trial ID: NCT05194137 on ClinicalTrials.gov

What this trial studies

This is a randomized, parallel two-arm trial comparing a proprioception training protocol delivered with biofeedback versus the same protocol delivered with vaginal palpation. Women who cannot perform a correct pelvic floor muscle contraction (Modified Oxford Scale grade 0–2) receive structured training with sessions at baseline and follow-ups at 3, 6, and 9 weeks, with contraction/rest timing standardized. The primary outcome is the proportion of women achieving a correct voluntary contraction (grade 3 or better). The trial is conducted at the Universidade de São Paulo site in Ribeirão Preto and uses an intention-to-treat comparison between the two teaching methods.

Who should consider this trial

Good fit: Women aged 18 or older with urinary incontinence who cannot perform a correct pelvic floor contraction (Modified Oxford Scale 0–2) and who can attend in-person sessions at the Universidade de São Paulo (Ribeirão Preto) are ideal candidates.

Not a fit: Women with pelvic neuropathy, active vaginal or urinary infection, advanced pelvic organ prolapse preventing evaluation (Baden-Walker stage >2), pregnant women, or those with significant cognitive impairment are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, more women who currently cannot contract their pelvic floor may learn a correct contraction, which could reduce urinary incontinence symptoms and improve quality of life.

How similar studies have performed: Biofeedback has shown benefit in some pelvic floor training studies, but direct comparative evidence versus vaginal palpation specifically for teaching an initial voluntary contraction is limited.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

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

Where this trial is running

Ribeirão Preto, São Paulo

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

Conditions Urinary Incontinence