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

NCT05194137 | Recruiting

• 1 other identifier: 32215720.0.0000.5440
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• change in ability to perform a voluntary PFM contraction

  be to gain the ability to perform a voluntary PFM contraction assessed by vaginal palpation and classified by the modified oxford scale (MOS). Women able to perform PFM contraction with both occlusion of the vaginal opening and inward movement will be considered able to perform a voluntary PFM contraction, this is the description of MOS grade 3.

  At baseline, 3, 6, 9 and 12 weeks

Secondary Outcomes (5)

• Urinary incontinence (UI)

  baseline and 12 weeks

• self-perception of pelvic floor muscle (PFM) contraction

  At baseline, 3, 6, 9 and 12 weeks

• adherence to treatment

  weekly up to 12 weeks

• adverse effects

  12 weeks

• satisfaction with treatment

  12 weeks

Study Arms (2)

a proprioception protocol associated with vaginal palpation and feedback (CG)

ACTIVE COMPARATOR

The participants of CG will be placed in the supine position with flexion of the hip and knee and feet supported on the stretcher. Vaginal palpation will be used as a proprioceptive resource to facilitate PFM voluntary contraction. The physiotherapist responsible for conducting the treatment, wearing gloves, will perform a one or two-finger vaginal palpation, depending on participant's vaginal canal. Positive reinforcements will be verbalized after each PFM contraction. The training protocol will be tailored, and the evolution will be the same for CG and BPFMT.

Other: a proprioception protocol associated with vaginal palpation and feedback

a proprioception protocol associated with biofeedback (BG)

EXPERIMENTAL

The participants of BG will receive the same protocol of CG but associated with biofeedback with an electromyographic sensor through the Miotol equipment (Miotec, Brazil). The participants of the BG will also be positioned in the same position described to CG. The electromyographic sensor will be covered with neutral gel and inserted into the participant's vaginal canal. Participants will see the visual response of the contraction on the computer screen. The software has five different interfaces for visualize PFM contraction and each participant will be able to choose the one that she prefers at each session. The training protocol will be tailored, and the evolution will be the same for CG and BG. During the first session, it will be explained what is biofeedback and what means everything that appears on the software interface.

Other: a proprioception protocol associated with biofeedback

Interventions

a proprioception protocol associated with vaginal palpation and feedback OTHER

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.

a proprioception protocol associated with vaginal palpation and feedback (CG)

a proprioception protocol associated with biofeedback OTHER

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.

a proprioception protocol associated with biofeedback (BG)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women who become pregnant while conducting the study
• Women with intolerance or pain that prevents the conduct of research protocols.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade de São Paulo

Ribeirão Preto, São Paulo, 14026-596, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher responsible for assessment and inclusion of participants in the study will be blinded to which group participants will be allocated to. The research assistant who is responsible for generate the list of randomized numbers and seal the envelope as well as the research assistant responsible to perform patients' allocation will not be involved in the recruitment, assessment of participants or interventions. Blinding of participants, and treatment providers: not possible Blinding of outcome measurement: Primary outcome - blinded assessment by a physiotherapist not involved in delivery of therapy or with knowledge of group allocation. All other outcomes - not blinded because they are patient-reported.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The randomization of the participants will be done using a computer-generated list of numbers (www.randomization.com). This list will be put in a sealed envelope and participants allocation will be concealed.

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: May 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)