Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence. This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT Pelvic Floor Muscle Training and 32 PFMT+AT Abdominal Training) by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks.

Detailed Description
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The aim of this study was to investigate the effectiveness of pelvic floor muscle and abdominal training in reproductive-age patients with stress urinary incontinence. This prospective randomized controlled design study included 64 female patients aged 18-49 years with stress urinary incontinence. The patients were divided into 2 groups (32 PFMT Pelvic Floor Muscle Training and 32 PFMT+AT Abdominal Training) by computer-based randomization. The stress urinary incontinence type was assessed by a stress test, and the pelvic floor muscle strength was measured with a home biofeedback device. Voiding functions were assessed by a 3-day voiding diary and uroflowmetric test. The UDI-6 scale was used to assess the urinary symptoms, and the IIQ-7 scale was used to assess the quality of life. The follow-up measurements of both groups were obtained in the 0th, 4th, and 8th weeks. Participation of 29 patients from each group in the study was determined as sufficient to test the two-way hypothesis, with an effect size of 0.75, with an alpha level of 0.05, and with a power of 80%. However, 32 patients from each group were included as a precaution against possible missing data. These women were randomly divided into the PFMT+AT (n=32) and PFMT (n=32) groups using a computer based randomization scheme. The data were collected from both groups at the 0th, 4th, and 8th weeks.

Official Title
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Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence: A Randomized Controlled Study

Conditions
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Stress Urinary Incontinence, Pelvic Floor Muscle Weakness

Intervention / Treatment
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* Other: Pelvic Floor Muscle Training and Abdominal Training
* Other: Pelvic Floor Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 18-49 years Meet the diagnosis of simple female stress urinary incontinence (Degree 0 or 1) Volunteer to participate the study Exclusion Criteria BMI ≥30 Hysterectomy, urinary incontinence or pelvic floor operations Chronic health problem (cardiovascular, cerebral, diabetes, liver, kidney, psychiatric disease, etc.) Urge urinary incontinence, mixed urinary incontinence, overflow urinary incontinence SUI Degree ≥2 Symptomatic urinary tract infection During pregnancy or lactation period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PFMT + AT<br>Pelvic Floor Muscle Training and Abdominal Training | Other: Pelvic Floor Muscle Training and Abdominal Training<br>* Pelvic Floor Muscle Training + Abdominal Training program was used in the study. The follow-up measurements of the PFMT+AT group were obtained in the 0th, 4th, and 8th weeks.<br>|
| Active Comparator: PFMT<br>Pelvic Floor Muscle Training | Other: Pelvic Floor Muscle Training<br>* Pelvic Floor Muscle Training program was used in the study. The follow-up measurements of the PFMT group were obtained in the 0th, 4th, and 8th weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pelvic floor muscle strength at 8 weeks | Pelvic floor muscle strength was measured using a perineometry device | 0th, 4th, and 8th weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline UDI-6 score at 8 weeks | Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6) | 0th, 4th, and 8th weeks. | 
| Change from baseline IIQ-7 score at 8 weeks | Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7), | 0th, 4th, and 8th weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, pelvic floor, stress urinary incontinence