Urinary IncontinenceNCT03325543
Can Women Correctly Contract Their Pelvic Floor Muscles After to Receive Verbal Instructions and Vaginal Palpation?
A study testing Visual observation and Vaginal palpation (bidigital touch) in people with Urinary Incontinence and Urinary Incontinence, Stress, run by Federal University of São Paulo at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders
- What is being tested?
- Visual observation and Vaginal palpation (bidigital touch)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2017to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with predominance of SUI symptoms and ≥ 2 g leakage measured by pad test and without capability to contract the PFM properly
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Lower Urinary Tract Symptoms
- Being tested
- Visual observation, Vaginal palpation (bidigital touch)
- Keywords
- Urinary Incontinence, Stress, Pelvic Floor, Exercise
- Medical subject headings
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Lower Urinary Tract Symptoms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual observationOther
Verbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Visual observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fast muscle fibres
Vaginal palpation (fast and with full force contraction, 1 second each)
Measured: After 4 weeks of supervised treatment
Secondary outcomes (3)
PFM function
Vaginal palpation
Measured: After 4 weeks of supervised treatment
Occurrence of associated contractions
Contractions of the abdominal, gluteal and adductor muscles during the voluntary contraction of PFM
Measured: 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.
Measured: Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start20 Dec 2017
- Primary completion27 Nov 2022
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia de Azevedo Ferreira, Federal University of São Paulo
- Investigators
- Letícia A Ferreira, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325543
- Sponsor's protocol ID
- 1
- Status last verified
- Jul 2025
- First submitted
- 16 Oct 2017
- Last updated
- 30 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32736576
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03325543
- Acronym / sponsor ID
- 1
- Conditions
- Urinary Incontinence, Urinary Incontinence, Stress, Urination Disorders, Lower Urinary Tract Symptoms
- Keywords
- Urinary Incontinence, Stress, Pelvic Floor, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 27 Nov 2022 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 30 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: verbal instruction + body awareness techniques + vaginal palpation | Experimental | Other: Visual observation, Other: Vaginal palpation (bidigital touch)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. |
| Control group: verbal instruction + body awareness techniques | Active comparator | Other: Visual observationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with predominance of SUI symptoms and ≥ 2 g leakage measured by pad test and without capability to contract the PFM properly
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual observationVerbal instructions about the anatomy, function and how to perform the pelvic floor muscle contraction | Other | Control group: verbal instruction + body awareness techniques, Experimental group: verbal instruction + body awareness techniques + vaginal palpation |
| Vaginal palpation (bidigital touch)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 | Other | Experimental group: verbal instruction + body awareness techniques + vaginal palpation |
Primary outcome
Number of fast muscle fibres
Time frame: After 4 weeks of supervised treatment
Vaginal palpation (fast and with full force contraction, 1 second each)
3 secondary outcomes
PFM function
Time frame: After 4 weeks of supervised treatment
Occurrence of associated contractions
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
Time frame: Questions about the expectation of results will be applied in the first week and after the fourth week of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Derived from this study: PubMed 32736576de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Letícia A Ferreira principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual observation and Vaginal palpation (bidigital touch) in people with Urinary Incontinence and Urinary Incontinence, Stress, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fast muscle fibres (time frame: After 4 weeks of supervised treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03325543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.