Biofeedback versus vaginal palpation to teach voluntary pelvic floor muscle contractions

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Universidade de São Paulo
  Ribeirão Preto, São Paulo, Brazil Recruiting

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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.