Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05194137

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

Led by University of Sao Paulo · Updated on 2025-08-22

100

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 or over
  • Women referred for physiotherapeutic treatment of pelvic floor dysfunction
  • Women unable to perform a pelvic floor muscle contraction (grade 0 or 1 on the modified Oxford scale)
  • Women with urinary incontinence (ICIQ-UI-SF score of 3 or higher)
  • Women who agree to participate by signing the informed consent form
Not Eligible

You will not qualify if you...

  • Women with pelvic floor dysfunction involving neuropathy
  • Women with vaginal or urological symptoms suggesting possible infections
  • Women with pelvic organ prolapse stage greater than 2 (Baden-Walker Scale) making evaluation or treatment impossible
  • Pregnant women
  • Women with cognitive impairment
  • Women who become pregnant during the study
  • Women who experience intolerance or pain preventing study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil, 14026-596

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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