Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence

The aim of the study was to compare the effects of stabilization exercises and pelvic floor muscle training in women with stress urinary incontinence.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Other: Pelvic floor exercises; Other: Stabilization exercises

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelvic floor exercise group; Pelvic floor exercises for muscle fiber types I and II will performed 3 days a week for 8 weeks	Other: Pelvic floor exercises; Pelvic floor exercises for types I and II muscle fibers will be performed
Active Comparator: Stabilization exercise group; Lumbar spinal stabilization exercises will performed 3 days a week for 8 weeks	Other: Stabilization exercises; Lumbar spinal stabilization exercises will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence severity	Urinary incontinence severity will be measured with A 1-hour pad test	change from baseline at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary symptoms	Urinary symptoms will be evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form	change from baseline at 8 weeks
Life quality	Life quality will be assessed with King's Health Questionnaire.	change from baseline at 8 weeks
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
Pelvic floor muscle strength	Pelvic floor muscle strength will be evaluated with Modified Oxford Scale	change from baseline at 8 weeks
Core stability	Core stability will be evaluated with Sahrmann Test using the pressure stabilizer.	change from baseline at 8 weeks
Balance	Balance will be evaluated with Biodex Balance System as static and dynamic	change from baseline at 8 weeks
Spinal function	Spinal function will be evaluated with the Spinal Mouse device in standing position.	change from baseline at 8 weeks
Subjective perception of improvement	Subjective perception of improvement will be measured with a four-point Likert scale.	After treatment (at 8 week)

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2022
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: January 2, 2022
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 2022/01/2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No