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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pelvic Floor Muscle Training | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| PFM function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pauliana CS Mendes | Contact | +55 16 99364-9581 | doutorapaulianasouza@outlook.com | |
| Cristine HJ Ferreira | Contact | +55 16 99621-7919 | cristine@fmrp.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pauliana Carolina de Souza Mendes | Recruiting | Franca | SĂŁo Paulo | 14408060 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37277833 | Derived | 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. |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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The principal investigator will be blind in relation to group allocation and the outcome assessor will be blind too in relation to group allocation
the modified Oxford grading scale- MOS (digital vaginal palpation)
| 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 | Women will be evaluated at baseline |
| 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 |
| 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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |