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

RecruitingNAAges 18 Years - anyFemaleUniversity of Sao Paulo
NCT05194137 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • a proprioception protocol associated with vaginal palpation and feedback
  • a proprioception protocol associated with biofeedback
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Where

1 site
Universidade de São Paulo
Ribeirão Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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