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Search / Trial NCT05194137

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

Launched by UNIVERSITY OF SAO PAULO · Jan 3, 2022

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to help women learn how to voluntarily contract their pelvic floor muscles, which can be important for managing urinary incontinence. The trial will compare the use of biofeedback (a tool that helps individuals understand their body functions) to vaginal palpation (a technique where a healthcare provider physically checks the muscles) to see which method is more effective. Pelvic floor muscle training is crucial for women who have difficulty controlling their bladder, and this study aims to find better ways to teach these techniques.

To participate, women must be 18 years or older and referred for treatment due to pelvic floor issues. They should have urinary incontinence and be unable to perform a pelvic floor muscle contraction, as assessed by a specific scale. However, women with certain conditions, such as infections, serious pelvic organ prolapse, or cognitive impairments, won't be eligible. If you join the trial, you will receive guidance and support as you learn to strengthen your pelvic floor muscles, which can help improve your symptoms. Your participation will contribute to finding better treatment options for women experiencing similar issues.

Gender

FEMALE

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.

About University Of Sao Paulo

The University of São Paulo (USP) is a prestigious public research university located in Brazil, renowned for its commitment to advancing knowledge and innovation in various fields, including medicine and health sciences. As a clinical trial sponsor, USP leverages its extensive academic resources, interdisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking research aimed at improving patient outcomes and addressing critical health challenges. The university's strong emphasis on ethical standards and regulatory compliance ensures that all clinical trials are conducted with the highest integrity, fostering collaboration among researchers, healthcare professionals, and the broader community to enhance scientific discovery and translate findings into practical applications.

Locations

Ribeirão Preto, São Paulo, Brazil

Ribeirão Preto, , Brazil

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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