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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05193435
Other study ID # 2022/01/2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 15, 2022
Est. completion date June 15, 2023

Study information

Verified date January 2022
Source Ankara Yildirim Beyazit University
Contact Seyda Toprak Celenay
Phone +90312 906 1000
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date June 15, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Other:
Pelvic floor exercises
Pelvic floor exercises for types I and II muscle fibers will be performed
Stabilization exercises
Lumbar spinal stabilization exercises will be performed

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Urinary incontinence severity Urinary incontinence severity will be measured with A 1-hour pad test change from baseline at 8 weeks
Secondary Urinary symptoms Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form change from baseline at 8 weeks
Secondary Life quality Life quality will be assessed with King's Health Questionnaire. change from baseline at 8 weeks
Secondary Pelvic floor muscle activation response Pelvic floor muscle activation response will be measured with a portable EMG-Biofeedback device. change from baseline at 8 weeks
Secondary Pelvic floor muscle strength Pelvic floor muscle strength will be evaluated with Modified Oxford Scale change from baseline at 8 weeks
Secondary Core stability Core stability will be evaluated with Sahrmann Test using the pressure stabilizer. change from baseline at 8 weeks
Secondary Balance Balance will be evaluated with Biodex Balance System as static and dynamic change from baseline at 8 weeks
Secondary Spinal function Spinal function will be evaluated with the Spinal Mouse device in standing position. change from baseline at 8 weeks
Secondary Subjective perception of improvement Subjective perception of improvement will be measured with a four-point Likert scale. After treatment (at 8 week)
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