Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
September 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2023
CompletedOctober 4, 2022
October 1, 2022
11 months
October 21, 2019
October 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
Women will be evaluated at baseline
Secondary Outcomes (6)
Participants' adherence to the PFMT protocol
Women will be evaluated at baseline and right after 12 weeks
PFM function
Women will be evaluated at baseline
participants self-perception of their PFM function
Women will be evaluated at baseline
Satisfaction with treatment
only after 12 weeks from the baseline assessment
Subjective satisfaction with treatment
only after 12 weeks from the baseline assessment
- +1 more secondary outcomes
Study Arms (2)
Group 1- diet therapy (control)
ACTIVE COMPARATORControl 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)
EXPERIMENTALThe 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.
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who do not wish to continue participating in the research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pauliana Carolina de Souza Mendes
Franca, São Paulo, 14408060, Brazil
Related Publications (1)
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.
PMID: 37277833DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist
Study Record Dates
First Submitted
October 21, 2019
First Posted
November 12, 2019
Study Start
September 28, 2022
Primary Completion
August 26, 2023
Study Completion
December 26, 2023
Last Updated
October 4, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will share