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

NCT ID: NCT05194137

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2026-07-01

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.

Detailed Description

Randomised, parallel (two arm), trial comparing biofeedback (experimental arm) versus vaginal palpation (active control, i.e. usual practice) to achieve a correct voluntary pelvic floor muscle contraction in women who cannot perform a correct contraction (i.e. grade 0, 1 or 2 on the Modified Oxford Scale). The trial hypothesis is that there is no difference between the two trial arms in the proportion of women achieving a correct voluntary contract (grade 3 or better).

The training protocol will be the same for both groups and will vary according to PFM function assessed at 0, 3, 6 and 9-week timepoint. The resting time after each contraction will be the double of the contraction duration, therefore if it is performed a 3-second contraction, it will be a 6-second rest. The first session will aim to improve some skills as understanding, searching, and finding PFM, the educational component of this session was structured considering Health Belief Model and will be conducted with the following information: 1) General information (female genital anatomy, female intern organs, pelvic floor muscle anatomy, pelvic floor muscle function), 2) specific information about urinary incontinence (definition of urinary incontinence, predictors of risk for urinary incontinence, impact on quality of life), 3) the relation between PFM and urinary incontinence, 4) pelvic floor muscle training as first line treatment for urinary incontinence, 5) how to include PFM proprioception protocol into daily life. It will be used as educational materials images and draws of the region and an educational booklet will be delivered to them. It will be shown to then a video of a PFM contraction emphasizing how the correct PFM contraction is supposed to be. The other sessions will focus will vary according to PFM function accessed at each timepoint:

• Participants classified with MOS 0 or 1: PFM protocol will aim on learning a PFM contraction and improve PFM perception
• Participants classified with MOS = 2: PFM protocol will aim on teaching how to control PFM contraction
• Participants classified with MOS ≥ 3: PFM protocol will aim on improving PFM strength

The resting time after each set will be 3 minutes and the protocol will evolve as following:

• WEEK 1: In clinics: 30 minutes: educational component as previous discussed. 30 minutes: The studied protocol will be explained as well as the need to fulfill a diary with their home training routine that should be delivered to the evaluator at the 12-week assessment. At each session, the physiotherapist will oversee the diary, take notes about the frequency of training, and orientate if necessary. To promote a first contact with their PFM, it will be performed 1 set of PFM contraction associated with vaginal palpation or biofeedback of 6 fast contraction according to the randomized group. The resting time after each contraction will be five seconds. Possible doubts will be clarified. At home: All participants will be oriented to perform 3 sets of 6 fast contraction daily during the following week in the supine position. The resting time after each contraction will be five seconds and after each set will be 2 minutes.
• WEEK 2-3: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 0. MOS 0: 3 sets of 6 fast contraction. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 6 fast contraction and 3 sets of 6 contractions sustained for 3 seconds. The resting time after each contraction will be five seconds and 2 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 0. MOS 0: 3 sets of 6 fast contraction in supine position. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 6 fast contraction and 3 sets of 6 contractions sustained for 3 seconds in supine. The resting time after each contraction will be five seconds and 2 minutes after each set.
• WEEK 4-6: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 3. MOS 0: 3 sets of 10 fast contraction. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 3. MOS 0: 3 sets of 10 fast contraction, each set on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.
• WEEK 7-9: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.
• WEEK 10-12: In clinics: Training diary will be overseen, and possible doubts will be clarified. Training protocol will be different according to PFM function assessed on week 9. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. The resting time after each contraction will be ten seconds and 3 minutes after each set. At home: Training protocol will be different according to PFM function assessed on week 6. MOS 0: 3 sets of 10 fast contraction and 3 sets of 5 contraction sustained for 3 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be five seconds and after each set will be 2 minutes. MOS 1: 3 sets of 10 fast contraction and 3 sets of 6 contractions sustained for 4 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be six seconds and 2 minutes after each set. MOS ≥ 2: 3 sets of 10 fast contraction and 3 sets of 10 contractions sustained for 6 seconds. Each set is supposed to be performed on a different position (i.e. supine, sitting and standing). The resting time after each contraction will be ten seconds and 3 minutes after each set.

The two groups will receive a booklet and guidance to perform the training protocol at home on alternate days and a diary to register their adherence to the program. The guided protocol will be the same used during the supervised training on that specific week. Women will be oriented to choose the position to practice unsupervised sessions (i.e. supine,lateral, sitting and/or standing).

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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.

Group Type: ACTIVE_COMPARATOR

a proprioception protocol associated with vaginal palpation and feedback

Intervention Type: 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 biofeedback (BG)

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.

Group Type: EXPERIMENTAL

a proprioception protocol associated with biofeedback

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

ANA CAROLINA NOCITI LOPES FERNANDES

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Cristine H J Ferreira

Role: primary

cristine@fmrp.usp.br

+551633150741

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

32215720.0.0000.5440

Identifier Type: -

Identifier Source: org_study_id