Outpatient and Home Pelvic Floor Training for Stress Urinary Incontinence

Study Overview
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Brief Summary
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The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. The hypothesis of this study is that home pelvic floor muscle training is as effective as outpatient pelvic floor muscle training for the treatment of stress urinary incontinence.

Detailed Description
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Success with the pelvic floor muscle training (PFMT) is hampered by non-adherence, which is related to factors such as inability to contract the pelvic floor muscles and lack of motivation. Thus under supervision by a physiotherapist (outpatient training), PFMT has the potential of improving adherence to training and has been demonstrated to be more effective when compared to unsupervised PFMT (home training). The objective of this study is to compare the effect of outpatient pelvic floor muscle training versus home pelvic floor muscle training in the treatment of stress urinary incontinence. This is a randomized controlled trial and which will be conducted at the Division of Urogynecology and Reconstructive Pelvic Surgery at the Federal University of Sao Paulo, Brazil. As a primary endpoint, the standardized volume test pad (250 mL) will be used. To assert that one of the groups (home PFMT or outpatient PFMT) is superior to the other, it will be necessary to find 38.5% more patients cured when the groups are compared. Secondary outcome measures will be used, assessment of the pelvic floor muscles function, urinary symptoms, quality of life and subjective cure.

Official Title
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Outpatient Pelvic Floor Muscle Training Versus Home Pelvic Floor Muscle Training for Stress Urinary Incontinence: Randomized Controlled Trial

Conditions
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Urinary Incontinence, Stress

Intervention / Treatment
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* Other: Exercises of the pelvic floor muscle at home
* Other: Exercises of the pelvic floor muscle in the outpatient


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SUI and mixed urinary incontinence with predominant symptoms of SUI with ≥ 2 g of leakage measured by pad test Exclusion Criteria: younger than 18 years old chronic degenerative diseases pelvic organ prolapse greater than stage I by POP-Q neurologic or psychiatric diseases inability to contract PFMs previously undergone pelvic floor re-education programs and/or previous pelvic floor surgeries

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Protocol of group I (Outpatient training): Patients will perform 24 outpatient sessions of pelvic floor muscle (PFM) strength training and home training. At the end of one month, the patients will perform PFM evaluation and training progression Group II protocol (home training): Patients will perform strength training of the pelvic floor muscles daily at home. At the end of one month, the patients will return for consultation, in which the PFM evaluation and training progression will be performed.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home pelvic floor muscle training<br>Patients will perform strength training of the pelvic floor muscles daily at home. The training protocol consists of three sets of 30 slow contractions (type I muscle fibers), with maintenance contraction according to the initial evaluation, followed by three rapid contractions (type II muscle fibers) after each slow contraction. The protocol will account for 90 contractions of the pelvic floor muscles per day. At the end of one month, the patients will return for consultation, in which the MAP evaluation and training progression will be performed. | Other: Exercises of the pelvic floor muscle at home<br>* Patients will perform pelvic floor exercises at home.<br>|
| Sham Comparator: Outpatient pelvic floor muscle training<br>The patients will perform 24 outpatient sessions of pelvic floor muscle strength training and home training. The training protocol consists of three sets of 30 slow contractions (type I muscle fibers), with maintenance contraction according to the initial evaluation, followed by three rapid contractions (type II muscle fibers) after each slow contraction. The protocol will account for 90 contractions of the pelvic floor muscles per day. At the end of one month, the patients will perform the evaluation of the MAP and progression of the training. | Other: Exercises of the pelvic floor muscle in the outpatient<br>* Patients will perform pelvic floor exercises in the outpatient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pad test | To quantify the severity of SUI and as the tool to estimate objective cure rate | Baseline, after 3 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 7-Day Voiding Diary | To assess the loss efforts | Baseline and after 3 months of treatment | 
| Change in pelvic floor muscle function (Oxford Grading Scale) | To assess the function of the pelvic floor muscle | Baseline and after 3 months of treatment | 
| Change in Incontinence Quality-of-Life Questionnaire (I-QoL) | To quantify the impact of SUI on quality of life | Baseline and after 3 months of treatment | 
| Subjective cure of SUI (satisfied or dissatisfied) | To evaluate the patient satisfaction with treatment | Baseline and after 3 months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Stress, Pelvic Floor; Exercise, Physical Therapy Modalities