Urinary IncontinenceNCT04159467
Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
A study testing Pelvic Floor Muscle Training in people with Urinary Incontinence and Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Obesity, Strength; Pelvic Floor
- What is being tested?
- Pelvic Floor Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 28 Sep 2022to 26 Dec 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service
- Women
- Over 18 years old
- With body mass index greater than 30kg / m2
- Who have reported urinary incontinence in the last four weeks
- Who have the ability to contract the pelvic floor muscles
- No report of neurological disease, no cognitive impairment
- That are not pregnant.
Who cannot join
- Women who do not wish to continue participating in the research.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Pauliana Carolina de Souza Mendes
Franca, São Paulo, 14408060
Pauliana Mendes, 16993649581, doutorapaulianasouza@outlook.com
About this study
Official title: Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial
The purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. The study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their PFM function, and satisfaction with treatment.
Read the detailed description
According to the World Health Organization (WHO), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. In addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (PFM) disorders and urinary incontinence (UI) is the most prevalent one. Conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (PFMT) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.
- Conditions
- Urinary Incontinence, Obesity, Strength; Pelvic Floor
- Being tested
- Pelvic Floor Muscle Training
- Keywords
- Urinary Incontinence, Obesity, Diet, Pelvic floor muscles training
- Medical subject headings
- Urinary Incontinence, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic Floor Muscle TrainingOther
4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).
| Study group | Role | What they receive |
|---|---|---|
| Group 1- diet therapy (control) | Active comparator | Control group undergoing a low calorie diet will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and after 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study. Receives: Other: Pelvic Floor Muscle Training |
| Grupo 2 - low calorie diet + PFMT (experimental) | Experimental | The experimental group will receive supervised pelvic floor muscle training in addition to a hypocaloric diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary contractions of the pelvic floor muscles. The 4 sets will be performed in 2 different positions (sitting and standing). Once a month, they will receive a supervised in-person session using the same protocol described above, in the other weeks of the month will receive a session supervised by telephysiotherapy once a week. In addition to supervised sessions, women will be encouraged to perform the protocol three more days a week. In addition, they will be instructed to perform "the knack" maneuver. Receives: Other: Pelvic Floor Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self report of urinary incontinence by women
Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.
Measured: Women will be evaluated at baseline
Severity and impact of Urinary incontinence in women´s quality of life
the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score
Measured: Women will be evaluated at baseline
Secondary outcomes (6)
Participants' adherence to the PFMT protocol
Will be assessed using an exercise diary and the complier average causal effects (CACE) method
Measured: Women will be evaluated at baseline and right after 12 weeks
PFM function
the modified Oxford grading scale- MOS (digital vaginal palpation)
Measured: Women will be evaluated at baseline
participants self-perception of their PFM function
women´s self-perception of their PFM function according to the MOS categories
Measured: Women will be evaluated at baseline
Satisfaction with treatment
Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction
Measured: only after 12 weeks from the baseline assessment
Subjective satisfaction with treatment
Women will answer the following questions: are you satisfied with the treatment you received for UI? would you do this treatment again ? would you recomend this treatment ? to other people, would you chase another treatment ?
Measured: only after 12 weeks from the baseline assessment
Identification of barriers for the treatment
Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?
Measured: only after 12 weeks from the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start28 Sep 2022
- Primary completion26 Aug 2023 (estimated)
- Study completion26 Dec 2023 (estimated)
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.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pauliana Carolina de Souza Mendes, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159467
- Sponsor's protocol ID
- 16379919.5.0000.5440
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2019
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Mendes PCS, Fretta TB, Camargo MFC, Driusso P, Homsi Jorge C. Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial. Trials. 2023 Jun 5;24(1):376. doi: 10.1186/s13063-023-07347-4.
PubMed 37277833
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet Prior to Bariatric Surgery: an Assessor Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04159467
- Acronym / sponsor ID
- 16379919.5.0000.5440
- Conditions
- Urinary Incontinence, Obesity, Strength; Pelvic Floor
- Keywords
- Urinary Incontinence, Obesity, Diet, Pelvic floor muscles training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 26 Aug 2023 (estimated)
- Study completion
- 26 Dec 2023 (estimated)
- First posted
- 12 Nov 2019 (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 purpose of this study is to assess the efficacy of pelvic floor muscle training (PFMT) on urinary incontinence reports in obese women undergoing a low calorie diet prior to bariatric surgery for obesity. The study will also assess and compare rates of adherence to treatments, pelvic floor muscle function and women´s self perception of their PFM function, and satisfaction with treatment.
Detailed description
According to the World Health Organization (WHO), the adult overweight rate in 2014 reached 20%, with the highest prevalence among women. In addition to metabolic diseases, obesity can cause musculoskeletal disorders, including pelvic floor muscle (PFM) disorders and urinary incontinence (UI) is the most prevalent one. Conservative intervention can be medication, lifestyle changes, but pelvic floor muscle training (PFMT) is considered the first-line conservative therapy for urinary incontinence in women and it is effective when delivered both individually or in group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- diet therapy (control) | Active comparator | Other: Pelvic Floor Muscle TrainingControl group undergoing a low calorie diet will not receive supervised pelvic floor muscle training. This group will be assessed at baseline and after 12 weeks. For ethics reason at the end of the study women of the control group will be invited to receive the pelvic floor muscle training program. However, this will not be part of the study. |
| Grupo 2 - low calorie diet + PFMT (experimental) | Experimental | Other: Pelvic Floor Muscle TrainingThe experimental group will receive supervised pelvic floor muscle training in addition to a hypocaloric diet. Women will be instructed to perform daily pelvic floor muscle training at home. 4 sets of 10 maximal voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary contractions of the pelvic floor muscles. The 4 sets will be performed in 2 different positions (sitting and standing). Once a month, they will receive a supervised in-person session using the same protocol described above, in the other weeks of the month will receive a session supervised by telephysiotherapy once a week. In addition to supervised sessions, women will be encouraged to perform the protocol three more days a week. In addition, they will be instructed to perform "the knack" maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of the outpatient bariatric surgery service that will start a low calorie diet program as part of the bariatric presurgery routine of the service
- Women
- Over 18 years old
- With body mass index greater than 30kg / m2
- Who have reported urinary incontinence in the last four weeks
Key exclusion criteria (1 listed)
- Women who do not wish to continue participating in the research.
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 |
|---|---|---|
| Pelvic Floor Muscle Training4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing). | Other | Group 1- diet therapy (control), Grupo 2 - low calorie diet + PFMT (experimental) |
Primary outcome
Self report of urinary incontinence by women
Time frame: Women will be evaluated at baseline
Self report of urinary incontinence measured using question 3 of the ICIQ-SF. Women will be considered incontinent if they choose option 1,2,3,4,5 of question 3. Women will be considered continent if they choose option 0 of question 3.
Severity and impact of Urinary incontinence in women´s quality of life
Time frame: Women will be evaluated at baseline
the severity and impact of Urinary incontinence in women´s quality of life will be measured using the ICIQ-SF score
6 secondary outcomes
Participants' adherence to the PFMT protocol
Time frame: Women will be evaluated at baseline and right after 12 weeks
PFM function
Time frame: Women will be evaluated at baseline
participants self-perception of their PFM function
Time frame: Women will be evaluated at baseline
Satisfaction with treatment
Time frame: only after 12 weeks from the baseline assessment
Subjective satisfaction with treatment
Time frame: only after 12 weeks from the baseline assessment
Identification of barriers for the treatment
Time frame: only after 12 weeks from the baseline assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Derived from this study: PubMed 37277833Mendes PCS, Fretta TB, Camargo MFC, Driusso P, Homsi Jorge C. Effect of pelvic floor muscle training on reports of urinary incontinence in obese women undergoing a low-calorie diet before bariatric surgery - protocol of a randomized controlled trial. Trials. 2023 Jun 5;24(1):376. doi: 10.1186/s13063-023-07347-4.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic Floor Muscle Training in people with Urinary Incontinence and Obesity, run by University of Sao 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 8 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: status not confirmed, as of the sponsor's last update on 4 Oct 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pauliana CS Mendes (+55 16 99364-9581, doutorapaulianasouza@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self report of urinary incontinence by women (time frame: Women will be evaluated at baseline). The study lists 2 primary outcomes in all. 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 NCT04159467, 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 4 Oct 2022.