Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence, Pelvic Floor Muscle Weakness
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training and Abdominal Training
Pelvic Floor Muscle Training
Sponsored by
About this trial
This is an interventional supportive care trial for Stress Urinary Incontinence focused on measuring exercise, pelvic floor, stress urinary incontinence
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PFMT + AT
PFMT
Arm Description
Pelvic Floor Muscle Training and Abdominal Training
Pelvic Floor Muscle Training
Outcomes
Primary Outcome Measures
Change from baseline pelvic floor muscle strength at 8 weeks
Pelvic floor muscle strength was measured using a perineometry device
Secondary Outcome Measures
Change from baseline UDI-6 score at 8 weeks
Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
Change from baseline IIQ-7 score at 8 weeks
Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03401983
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Trakya University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Pelvic Floor Muscle Weakness
Keywords
exercise, pelvic floor, stress urinary incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PFMT + AT
Arm Type
Experimental
Arm Description
Pelvic Floor Muscle Training and Abdominal Training
Arm Title
PFMT
Arm Type
Active Comparator
Arm Description
Pelvic Floor Muscle Training
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training and Abdominal Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline pelvic floor muscle strength at 8 weeks
Description
Pelvic floor muscle strength was measured using a perineometry device
Time Frame
0th, 4th, and 8th weeks.
Secondary Outcome Measure Information:
Title
Change from baseline UDI-6 score at 8 weeks
Description
Urinary symptoms were measured using the Urinary Distress Inventory (UDI-6)
Time Frame
0th, 4th, and 8th weeks.
Title
Change from baseline IIQ-7 score at 8 weeks
Description
Urinary symptoms were measured using the Incontinence Impact Questionnaire (IIQ-7),
Time Frame
0th, 4th, and 8th weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Pelvic Floor Muscle and Abdominal Training in Women With Stress Urinary Incontinence
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