Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet

Not Applicable

Recruiting

• Conditions: Obesity; Strength; Pelvic Floor; Urinary Incontinence
• Interventions: Other: Pelvic Floor Muscle Training

• Registration Number: NCT04159467
• Lead Sponsor: University of Sao Paulo

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.

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 Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-11-07
• Study First Posted: 2019-11-12
• Study Start: 2022-09-28
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-03
• Last Update Posted: 2022-10-04
• Primary Completion: 2023-08-26
• Study Completion: 2023-12-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• 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.

Exclusion Criteria

• Women who do not wish to continue participating in the research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grupo 2 - low calorie diet + PFMT (experimental)	Pelvic Floor Muscle Training	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.
Group 1- diet therapy (control)	Pelvic Floor Muscle Training	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.

Primary Outcome Measures

Name	Time	Method
Self report of urinary incontinence by women	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	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

Secondary Outcome Measures

Name	Time	Method
participants self-perception of their PFM function	Women will be evaluated at baseline	women´s self-perception of their PFM function according to the MOS categories
Satisfaction with treatment	only after 12 weeks from the baseline assessment	Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction
Participants' adherence to the PFMT protocol	Women will be evaluated at baseline and right after 12 weeks	Will be assessed using an exercise diary and the complier average causal effects (CACE) method
PFM function	Women will be evaluated at baseline	the modified Oxford grading scale- MOS (digital vaginal palpation)
Identification of barriers for the treatment	only after 12 weeks from the baseline assessment	Women will answer the following questions: Do identifie any barrier or difficulty to adhere to the treatment you received for urinary incontinence?
Subjective satisfaction with treatment	only after 12 weeks from the baseline assessment	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 ?

Trial Locations

Locations (1)

Pauliana Carolina de Souza Mendes; 🇧🇷 Franca, SP, Brazil