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RECRUITING
NCT05194137
NA

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

Sponsor: University of Sao Paulo

View on ClinicalTrials.gov

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.

Official title: Biofeedback Versus Vaginal Palpation to Teach a Voluntary Pelvic Floor Muscle Contraction to Women Incapable of Performing it? A Non-inferiority Randomized Controled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2022-05-01

Completion Date

2026-07-01

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

OTHER

a proprioception protocol associated with vaginal palpation and feedback

A total of 13 previously established examples of voice commands can be used by the physiotherapists to help women understand how to perform a PFM contraction.

OTHER

a proprioception protocol associated with biofeedback

The software has five different interfaces for visualize PFM contraction: sign itself and signal transformed into the movement of a balloon; an airplane; a fairy; or a bird. Positive reinforcements will be verbalized after each PFM contraction using one of 4 previously established examples of voice commands.

Locations (1)

Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil