About this trial
Urinary incontinence 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 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.
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.
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. The assessments will be conducted at baseline, week 8, and week 12.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female participants aged 20-50 years.
Diagnosed with urinary incontinence.
Able to understand study instructions.
Willing to provide informed consent
Disqualifiers
Delivery within the previous 3 months.
Gynecological surgery during the previous 3 months.
Lower urinary tract surgery during the previous 3 months.
Postmenopausal women.
Trial design
Parallel
Treatments tested in this trial
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 interventionKegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.
Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
Other interventionClinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
Treatment groups
Trial outcomes
Primary outcomes
Perineometer
Pelvic floor muscle strength will be measured using a perineometer min 0 cmH₂O and max 300 cmH₂O. Higher scores indicate greater pelvic floor muscle strength
Secondary outcomes
long-term Pad Test
Urinary leakage severity will be measured using the long-term Pad Test. Minimum value of 0 g. Higher values indicate greater urinary leakage and therefore worse urinary incontinence. Lower values indicate less urinary leakage and better outcome.
King's Health Questionnaire
• Quality of life will be measured using the King's Health Questionnaire with min score 0 and max score 100 for each domain. Lower scores indicate better quality of life.
Sponsors and contacts
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