- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07795931
A Comparison of Home-Based Kegel Exercises Versus Clinic-Based Rehabilitation in Women With Urinary Incontinence in the Tabuk Region: A Randomized Controlled Trial (Incontinence)
Background Urinary incontinence (UI) is a common condition among women that significantly affects physical health, emotional well-being, social participation, and overall quality of life. Pelvic floor muscle training (PFMT) is widely recommended as the first-line conservative treatment for urinary incontinence. While clinic-based rehabilitation provides direct supervision by healthcare professionals, home-based Kegel exercise programs offer greater convenience and accessibility. However, limited evidence exists regarding the comparative effectiveness of these approaches among women in Saudi Arabia.
Aim The study aims to compare the effectiveness of home-based Kegel exercises and clinic-based rehabilitation programs in improving pelvic floor muscle strength, reducing urinary incontinence symptoms, and enhancing quality of life among women with urinary incontinence in the Tabuk region.
Objectives
- To evaluate the effectiveness of home-based Kegel exercises in women with urinary incontinence.
- To evaluate the effectiveness of clinic-based pelvic floor rehabilitation.
- To compare outcomes between both intervention approaches.
- To compare the outcomes of both interventions regarding pelvic floor muscle strength, urinary leakage, and quality of life.
- To assess participants' adherence to the prescribed exercise programs. Methodology
This study will employ a randomized controlled trial (RCT) design. Eligible women diagnosed with urinary incontinence will be recruited from the Maternity and Children Hospital, Tabuk. Participants will be randomly assigned to one of two groups:
- Group A: Home-based Kegel exercise program.
- Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures
The effectiveness of the interventions will be evaluated using:
- Perineometer measurements to assess pelvic floor muscle strength.
- Pad Test to assess urinary leakage severity.
- King's Health Questionnaire (KHQ) to evaluate quality of life.
- Adherence records to monitor compliance with the exercise program. Assessments will be conducted at baseline, week 8, and week 12. Data Analysis Data will be analyzed using SPSS software. Descriptive statistics, independent t-tests, Chi-square tests, and repeated-measures ANOVA will be used to compare outcomes between groups. Statistical significance will be set at p < 0.05.
Ethical Considerations Ethical approval will be obtained prior to study commencement. Written informed consent will be obtained from all participants. Participation will be voluntary, confidentiality will be maintained, and participants will have the right to withdraw from the study at any time without affecting their healthcare services.
Expected Outcomes The study is expected to demonstrate improvements in pelvic floor muscle strength, urinary continence, and quality of life in both groups. The findings will provide evidence regarding whether home-based Kegel exercises can achieve outcomes comparable to supervised clinic-based rehabilitation, thereby informing future physiotherapy practice and healthcare policy.
Significance This research will contribute to the growing body of evidence on pelvic floor rehabilitation and may support the implementation of accessible, cost-effective, and evidence-based treatment options for women with urinary incontinence in Tabuk region in Saudi Arabia. The results may also guide clinicians and healthcare decision-makers in optimizing rehabilitation services and improving patient outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
- Other: Home -Based Kegel Trainer Exercises (Kegel Trainer Application) will be used by the participants at home for training the pelvic floor muscles over 9 levels.
- Other: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Tabuk Region
-
Tabuk, Tabuk Region, Saudi Arabia
- Maternity and Children Hospital in Tabuk
-
Contact:
- Enas Elsayed Abutaleb, PhD
- Phone Number: 0536346062
- Email: eabutaleb@ut.edu.sa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female participants aged 20-50 years.
- Diagnosed with urinary incontinence.
- Able to understand study instructions.
- Willing to provide informed consent
Exclusion Criteria:
- Delivery within the previous 3 months.
- Gynecological surgery during the previous 3 months.
- Lower urinary tract surgery during the previous 3 months.
- Postmenopausal women.
- Contraindications to pelvic floor muscle training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-Based Kegel Exercises
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will use an AI trainer called Kegel trainer for 12 weeks focusing on strengthening the pelvic floor muscles.
They will join a telegram group supervised by the caregiver to follow their interactions during the whole period.
|
Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.
Other Names:
|
|
Experimental: Clinic-Based Rehabilitation Program
Women diagnosed with urinary incontinence in this arm attending the Women's Department of Maternity and Children Hospital will be supervised by the Physiotherapist at the department for two times per week during the Kegel training for pelvic floor muscles training for 12 weeks .
|
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perineometer
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Pelvic floor muscle strength will be measured using a perineometer
|
From enrollment to the end of treatment at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
long-term Pad Test
Time Frame: From enrollment to the end of treatment at 12 weeks
|
Urinary leakage severity will be measured using the long-term Pad Test
|
From enrollment to the end of treatment at 12 weeks
|
|
King's Health Questionnaire
Time Frame: From enrollment to the end of treatment at 12 weeks
|
• Quality of life will be measured using the King's Health Questionnaire
|
From enrollment to the end of treatment at 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence
Other Study ID Numbers
- University of Tabuk (UTabuk)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.