Stress Urinary Incontinence Clinical Trial
Official title:
Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence: A Randomized Controlled Study
Verified date | January 2018 |
Source | Trakya University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | March 31, 2017 |
Est. primary completion date | March 31, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Trakya University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | |
Secondary | 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 |
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