An interventional study of Visual observation and Vaginal palpation (bidigital touch) in Urinary Incontinence, Urinary Incontinence, Stress and Urination Disorders, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Federal University of São Paulo · Not applicable, Interventional, and Treatment
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.
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 176 is above the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
Compared within Urinary Incontinence, Stress, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Incontinence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
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
Verbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction
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
Number of fast muscle fibres
Vaginal palpation (fast and with full force contraction, 1 second each)
Time frame: After 4 weeks of supervised treatment
PFM function
Vaginal palpation
Time frame: After 4 weeks of supervised treatment
Occurrence of associated contractions
Contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM
Time frame: 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
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.
Time frame: Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.
Plan to share: No
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Urinary Incontinence, Stress →
Federal University of São Paulo →