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

Urinary Incontinence Clinical Trial

Official title:

Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation? Protocol of a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03325543
• Other study ID #: 1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 16, 2017
• Last updated: November 30, 2017
• Start date: December 1, 2017
• Est. completion date: October 27, 2018

Study information

• Verified date: November 2017
• Source: Federal University of São Paulo
• Contact: Letícia Ferreira
• Phone: 55 11 994001829
• Email: leticia_azfe[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Research Questions: The objectives of this study is to test the hypothesis that the provision of verbal instructions about the anatomy and function of PFMs associated with the use of body techniques awareness and vaginal palpation helps in learning the correct contraction and improves the function of the PFMs.

Design: A single-centered, double-blind (investigator and outcome assessor) randomised controlled trial with two physiotherapy intervention groups.

Measurements: The primary outcome measure will be the EMG activity of the PFMs, gluteus maximus, hip adductor, and the group formed by the abdominal transverse (TrA) and internal oblique (IO) muscles during rest and maximal voluntary contractions (MVCs). The secondary outcome measure will be the PFM function (vaginal palpation and visual observation), posture assessment (software SAPO), and self-efficacy scale for practising PFM exercises.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 27, 2018
• Est. primary completion date: October 27, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Enuresis
• Lower Urinary Tract Symptoms
• Urinary Incontinence
• Urinary Incontinence, Stress
• Urination Disorders

Intervention

Other:
• Verbal instruction and Vaginal palpation
The experimental 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 control group will receive only verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques.

Locations

Country	Name	City	State
Brazil	Letícia de Azevedo Ferreira	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromyography (EMG)	EMG activity muscles during rest and maximal voluntary contractions (MVCs)	After 4 weeks of supervised treatment
Secondary	PFM function	Vaginal palpation	After 4 weeks of supervised treatment
Secondary	Posture assessment	Software SAPO	After 4 weeks of supervised treatment
Secondary	Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises	The scale is composed of 17 questions in the visual analogue scale format with responses ranging from 0 (not confident) to 100 (most confident). Thirteen questions refer to self-efficacy and four questions to expectation of results. The final result is obtained by averaging the items, which ranges from 0 to 100, where higher values are equivalent to more beneficial action of self-efficacy / expected result of the training of the PFM.	Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.