[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654133":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":31,"studyPopulation":20,"armGroups":32,"interventions":44,"overallOfficials":55,"centralContacts":20,"locations":59,"responsibleParty":78,"collaborators":20,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":20,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":103,"whyStopped":20,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University of Tabuk","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"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","From enrollment to the end of treatment at 12 weeks",[14,17],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",null,{"allocation":22,"interventionModel":23,"interventionModelDescription":20,"primaryPurpose":24,"observationalModel":20,"timePerspective":20,"maskingInfo":25},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":26,"maskingDescription":20,"whoMasked":27},"TRIPLE",[28,29,30],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","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.\n\nAim 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.\n\nObjectives\n\n1. To evaluate the effectiveness of home-based Kegel exercises in women with urinary incontinence.\n2. To evaluate the effectiveness of clinic-based pelvic floor rehabilitation.\n3. To compare outcomes between both intervention approaches.\n4. To compare the outcomes of both interventions regarding pelvic floor muscle strength, urinary leakage, and quality of life.\n5. To assess participants' adherence to the prescribed exercise programs. Methodology\n\nThis 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:\n\n* Group A: Home-based Kegel exercise program.\n* Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures\n\nThe effectiveness of the interventions will be evaluated using:\n\n* Perineometer measurements to assess pelvic floor muscle strength.\n* Pad Test to assess urinary leakage severity.\n* King's Health Questionnaire (KHQ) to evaluate quality of life.\n* 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 \\\u003C 0.05.\n\nEthical 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.\n\nExpected 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.\n\nSignificance 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.",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Home-Based Kegel Exercises","EXPERIMENTAL","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.",[38],"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.",{"label":40,"type":35,"description":41,"interventionNames":42},"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 .",[43],"Other: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months",[45,52],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"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.","Kegel exercises are designed to focus on strengthening the weak pelvic floor muscles by using Kegel Trainer Application over 9 levels.",[34],[50,51],"Kegel Trainer","Pelvic floor muscle exercises",{"type":6,"name":53,"description":53,"armGroupLabels":54,"otherNames":20},"Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months",[40],[56],{"name":57,"affiliation":5,"role":58},"Enas ES Abutaleb, Associate Professor","PRINCIPAL_INVESTIGATOR",[60],{"facility":61,"status":20,"city":62,"state":63,"zip":20,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Maternity and Children Hospital in Tabuk","Tabuk","Tabuk Region","Saudi Arabia","SA",{"type":67,"coordinates":68},"Point",[69,70],36.57151,28.3998,{"lat":70,"lon":69},[73],{"name":74,"role":75,"phone":76,"phoneExt":20,"email":77},"Enas ES Abutaleb, PhD","CONTACT","0536346062","eabutaleb@ut.edu.sa",{"type":58,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Enas Elsayed Mohamed Abutaleb","Associate Professor of Physical Therapy-University of Tabuk,Professor of Physical Therapy- Cairo University,","100654133","a-comparison-of-home-based-kegel-exercises-versus-clinic-based-rehabilitation-in-women-with-urinary-incontinence-in-the-tabuk-region-a-randomized-controlled-trial-100654133",false,"NCT07795931","Comparison of Home Versus Clinic Kegel Rehabilitation in Women With Urinary Incontinence in the Tabuk Region","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","Inclusion Criteria:\n\n* Female participants aged 20-50 years.\n* Diagnosed with urinary incontinence.\n* Able to understand study instructions.\n* Willing to provide informed consent\n\nExclusion Criteria:\n\n* Delivery within the previous 3 months.\n* Gynecological surgery during the previous 3 months.\n* Lower urinary tract surgery during the previous 3 months.\n* Postmenopausal women.\n* Contraindications to pelvic floor muscle training.","FEMALE","20 Years","50 Years",{"count":93,"type":94},100,"ESTIMATED","INTERVENTIONAL",[97],"NA","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.\n\nThe 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.\n\nThis 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:\n\n* Group A: Home-based Kegel exercise program.\n* Group B: Supervised clinic-based pelvic floor rehabilitation program. Both interventions will be conducted over a 12-week period. Outcome Measures\n\nThe effectiveness of the interventions will be evaluated using:\n\n* Perineometer measurements to assess pelvic floor muscle strength.\n* Pad Test to assess urinary leakage severity.\n* King's Health Questionnaire (KHQ) to evaluate quality of life.\n* Adherence records to monitor compliance with the exercise program. The assessments will be conducted at baseline, week 8, and week 12.",[100],"Urinary Incontinence (UI)",[102],"Urinary incontinence, Pelvic floor muscles, Kegel Exrecises","NOT_YET_RECRUITING","2026-09-23",{"date":106,"type":107},"2026-09-25","ACTUAL",{"date":109,"type":94},"2026-10-01",{"date":111,"type":94},"2027-03-01",{"name":5,"class":6},1]