NCT05194137 Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction
| NCT ID | NCT05194137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2022-05-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Frequently Asked Questions
Who can join the NCT05194137 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05194137 currently recruiting?
Yes, NCT05194137 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Sao Paulo to inquire about joining.
Where is the NCT05194137 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT05194137 clinical trial?
NCT05194137 is sponsored by University of Sao Paulo. The trial plans to enroll 100 participants.