Back to resultsComparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic floor exercises
Stabilization exercises
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study
Exclusion Criteria:
- Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pelvic floor exercise group
Stabilization exercise group
Arm Description
Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks
Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks
Outcomes
Primary Outcome Measures
Urinary incontinence severity
Urinary incontinence severity will be measured with A 1-hour pad test
Secondary Outcome Measures
Urinary symptoms
Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Life quality
Life quality will be assessed with King's Health Questionnaire.
Pelvic floor muscle activation response
Pelvic floor muscle activation response will be measured with a portable EMG-Biofeedback device.
Pelvic floor muscle strength
Pelvic floor muscle strength will be evaluated with Modified Oxford Scale
Core stability
Core stability will be evaluated with Sahrmann Test using the pressure stabilizer.
Balance
Balance will be evaluated with Biodex Balance System as static and dynamic
Spinal function
Spinal function will be evaluated with the Spinal Mouse device in standing position.
Subjective perception of improvement
Subjective perception of improvement will be measured with a four-point Likert scale.
Full Information
NCT ID
NCT05193435
First Posted
January 2, 2022
Last Updated
January 2, 2022
Sponsor
Ankara Yildirim Beyazıt University
1. Study Identification
Unique Protocol Identification Number
NCT05193435
Brief Title
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Official Title
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2022 (Anticipated)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Yildirim Beyazıt University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.
Detailed Description
Stress urinary incontinence is involuntary urinary incontinence with increased intraabdominal pressure. Different exercise approaches such as pelvic floor exercises and stabilization exercises are used in these patients. There is a need for studies comparing the effects of these exercises.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pelvic floor exercise group
Arm Type
Experimental
Arm Description
Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks
Arm Title
Stabilization exercise group
Arm Type
Active Comparator
Arm Description
Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercises
Intervention Description
Pelvic floor exercises for types I and II muscle fibers will be performed
Intervention Type
Other
Intervention Name(s)
Stabilization exercises
Intervention Description
Lumbar spinal stabilization exercises will be performed
Primary Outcome Measure Information:
Title
Urinary incontinence severity
Description
Urinary incontinence severity will be measured with A 1-hour pad test
Time Frame
change from baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Urinary symptoms
Description
Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form
Time Frame
change from baseline at 8 weeks
Title
Life quality
Description
Life quality will be assessed with King's Health Questionnaire.
Time Frame
change from baseline at 8 weeks
Title
Pelvic floor muscle activation response
Description
Pelvic floor muscle activation response will be measured with a portable EMG-Biofeedback device.
Time Frame
change from baseline at 8 weeks
Title
Pelvic floor muscle strength
Description
Pelvic floor muscle strength will be evaluated with Modified Oxford Scale
Time Frame
change from baseline at 8 weeks
Title
Core stability
Description
Core stability will be evaluated with Sahrmann Test using the pressure stabilizer.
Time Frame
change from baseline at 8 weeks
Title
Balance
Description
Balance will be evaluated with Biodex Balance System as static and dynamic
Time Frame
change from baseline at 8 weeks
Title
Spinal function
Description
Spinal function will be evaluated with the Spinal Mouse device in standing position.
Time Frame
change from baseline at 8 weeks
Title
Subjective perception of improvement
Description
Subjective perception of improvement will be measured with a four-point Likert scale.
Time Frame
After treatment (at 8 week)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women between the ages of 18-65 who have symptoms of stress or stress-dominant mixed urinary incontinence, who volunteered to participate in the study
Exclusion Criteria:
Those who are pregnant, have communication and cooperation problems, have a concomitant neurological or rheumatological disease, have a history of surgery involving the abdominal and pelvic regions in the last year, have undergone spine surgery, those diagnosed with pure urge urinary incontinence or mixed type incontinence, those with advanced pelvic organ prolapse, those with a spinal deformity (such as scoliosis), the presence of orthopedic problems in the lower extremities (such as lower extremity shortness, presence of deformity etc.) and vestibular system disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyda Toprak Celenay
Phone
+90312 906 1000
Email
sydtoprak@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda Toprak Celenay
Organizational Affiliation
Ankara Yildirim Beyazıt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
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