Clinical trial NCT03325543: Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Lower Urinary Tract Symptoms
Keywords: Urinary Incontinence, Stress
Pelvic Floor
Exercise
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 177
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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 number of fast muscle fibres, as determined by the number of effective contractions (fast and with full force contraction, 1 second each) out of ten contractions performed. The secondary outcome measure will be the PFM function (vaginal palpation and visual observation), the occurrence of associated contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM , and self-efficacy scale for practising PFM exercises.

Eligibility criteria: 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

Primary outcomes:
measure: Number of fast muscle fibres
timeFrame: After 4 weeks of supervised treatment
Secondary outcomes:
measure: PFM function
timeFrame: After 4 weeks of supervised treatment
measure: Occurrence of associated contractions
timeFrame: After 4 weeks of supervised treatment
measure: Self-perception of the effectiveness of perineal exercises will be evaluated by the Self-Efficacy Scale for Practice of Pelvic Floor Exercises
timeFrame: Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Letícia de Azevedo Ferreira
Study officials:
affiliation: Federal University of São Paulo
name: Letícia A Ferreira
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.