Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?

NCT03325543 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The pelvic floor muscle training (PFMT) is a conservative treatment, currently considered as first line for women with stress urinary incontinence (SUI). However, in practice, about 30 to 50% of women are unable to perform the correct contraction of the pelvic floor muscles (PFMs). When requested to perform the muscle contraction, the contraction of the gluteal muscles, hip adductors, or abdominal muscles is observed initially, rather of contraction of the levator anus muscle. Some factors make it difficult to perform the contraction of the PFM, such as its location on the pelvic floor, and its small size, followed by a lack of knowledge of the pelvic region, as well as its functions. Associated with these factors is the use of the muscles adjacent to the PFM, as previously mentioned. In order for women to benefit from a PFMT program for the treatment of SUI, the awareness phase of PFM can't be omitted, since the literature is unanimous in stating that pelvic exercises improve the recruitment capacity of the musculature, its tone and reflex coordination during the effort activities.

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urination Disorders; Lower Urinary Tract Symptoms

Keywords

Urinary Incontinence, Stress; Pelvic Floor; Exercise

Outcome Measures

Primary Outcomes (1)

• Number of fast muscle fibres

  Vaginal palpation (fast and with full force contraction, 1 second each)

  After 4 weeks of supervised treatment

Secondary Outcomes (3)

• PFM function

  After 4 weeks of supervised treatment

• Occurrence of associated contractions

  After 4 weeks of supervised treatment

• Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises

  Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.

Study Arms (2)

Experimental group: verbal instruction + body awareness techniques + vaginal palpation

EXPERIMENTAL

The intervention group will receive verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques and vaginal palpation to learn the correct PFMs contraction. The intervention program will last four weeks, and will contain four outpatient consultations (1 session per week) lasting 60 minutes each session.

Other: Visual observation; Other: Vaginal palpation (bidigital touch)

Control group: verbal instruction + body awareness techniques

ACTIVE COMPARATOR

The control group will receive visual and verbal orientations of the anatomy and function of PFMs associated with the use of body awareness techniques and visual observation of the PFM.

Other: Visual observation

Interventions

Visual observation OTHER

Verbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction

Control group: verbal instruction + body awareness techniques; Experimental group: verbal instruction + body awareness techniques + vaginal palpation

Vaginal palpation (bidigital touch) OTHER

The physiotherapist touched the patients' perineal region (vulva, tendinous centre of the perineum and external region of the anal canal) with a spatula and asked them to identify the pointed region; and with the digital palpation, the physiotherapist touched the tendinous centre of the perineum, pressing it in the cranial direction, and instructed the patients to contract the pelvic floor muscle

Experimental group: verbal instruction + body awareness techniques + vaginal palpation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with predominance of SUI symptoms and ≥ 2 g leakage measured by pad test and without capability to contract the PFM properly

You may not qualify if:

• Not included if they were younger than 18 years old, had chronic degenerative diseases, pelvic organ prolapse greater than stage I by POP-Q, neurologic or psychiatric diseases, ability to contract PFMs, had previous pelvic floor re-education programs and/or pelvic floor surgeries

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Letícia de Azevedo Ferreira

São Paulo, 04042005, Brazil

Location

Related Publications (1)

• de Azevedo Ferreira L, Fitz FF, Gimenez MM, Matias MMP, Bortolini MAT, Castro RA. The role of vaginal palpation in motor learning of the pelvic floor muscles for women with stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2020 Jul 31;21(1):693. doi: 10.1186/s13063-020-04624-4.

  PMID: 32736576 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress; Urination Disorders; Lower Urinary Tract Symptoms; Motor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Letícia A Ferreira

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: October 30, 2017
• Study Start: December 20, 2017
• Primary Completion: November 27, 2022
• Study Completion: July 31, 2023
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)