Obesity, Strength; Pelvic Floor, Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Obesity, Diet, Pelvic floor muscles training
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.
Interventions
OTHERPelvic 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).
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 ? |
| PFM function | Women will be evaluated at baseline | the modified Oxford grading scale- MOS (digital vaginal palpation) |
Countries
Brazil
Contacts
Primary ContactPauliana CS Mendes
Backup ContactCristine HJ Ferreira
Outcome results
None listed