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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159467
• Other study ID #: 16379919.5.0000.5440
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: December 26, 2023

Study information

• Verified date: October 2022
• Source: University of Sao Paulo
• Contact: Pauliana CS Mendes
• Phone: +55 16 99364-9581
• Email: doutorapaulianasouza[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 26, 2023
• Est. primary completion date: August 26, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Obesity
• Strength; Pelvic Floor
• Urinary Incontinence

Intervention

Other:
• Pelvic Floor Muscle Training
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).

Locations

Country	Name	City	State
Brazil	Pauliana Carolina de Souza Mendes	Franca	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Participants' adherence to the PFMT protocol	Will be assessed using an exercise diary and the complier average causal effects (CACE) method	Women will be evaluated at baseline and right after 12 weeks
Secondary	PFM function	the modified Oxford grading scale- MOS (digital vaginal palpation)	Women will be evaluated at baseline
Secondary	participants self-perception of their PFM function	women´s self-perception of their PFM function according to the MOS categories	Women will be evaluated at baseline
Secondary	Satisfaction with treatment	Analogic visual scale where 0 represents no satisfaction with treatment and 10 the maximum satisfaction	only after 12 weeks from the baseline assessment
Secondary	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 ?	only after 12 weeks from the baseline assessment
Secondary	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?	only after 12 weeks from the baseline assessment