Clinical trial NCT03401983: Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence
Official title: Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor Muscle Weakness
Keywords: exercise
pelvic floor
stress urinary incontinence
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline pelvic floor muscle strength at 8 weeks
timeFrame: 0th, 4th, and 8th weeks.
Secondary outcomes:
measure: Change from baseline UDI-6 score at 8 weeks
timeFrame: 0th, 4th, and 8th weeks.
measure: Change from baseline IIQ-7 score at 8 weeks
timeFrame: 0th, 4th, and 8th weeks
Other outcomes:
Locations:
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