A Comparison of Home-Based Kegel Exercises Versus Clinic-Based Rehabilitation in Women With Urinary Incontinence in the Tabuk Region: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Perineometer
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 20-50 years.
- •Diagnosed with urinary incontinence.
- •Able to understand study instructions.
- •Willing to provide informed consent
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 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
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 .
干预措施: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months (Other)
结局指标
主要结局
Perineometer
时间窗: From enrollment to the end of treatment at 12 weeks
Pelvic floor muscle strength will be measured using a perineometer
次要结局
- long-term Pad Test(From enrollment to the end of treatment at 12 weeks)
- King's Health Questionnaire(From enrollment to the end of treatment at 12 weeks)
研究者
Enas Elsayed Mohamed Abutaleb
Associate Professor of Physical Therapy-University of Tabuk,Professor of Physical Therapy- Cairo University,
University of Tabuk