- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
- Другой: 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.
- Другой: Clinic-Based Rehabilitation Program will consist of physiotherapist supervised pelvic floor strengthening exercises for the participant , 2 times per week for 3 months
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Tabuk Region
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Tabuk, Tabuk Region, Саудовская Аравия
- Maternity and Children Hospital in Tabuk
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Контакт:
- Enas Elsayed Abutaleb, PhD
- Номер телефона: 0536346062
- Электронная почта: eabutaleb@ut.edu.sa
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Perineometer
Временное ограничение: From enrollment to the end of treatment at 12 weeks
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Pelvic floor muscle strength will be measured using a perineometer
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From enrollment to the end of treatment at 12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
long-term Pad Test
Временное ограничение: From enrollment to the end of treatment at 12 weeks
|
Urinary leakage severity will be measured using the long-term Pad Test
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From enrollment to the end of treatment at 12 weeks
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|
King's Health Questionnaire
Временное ограничение: From enrollment to the end of treatment at 12 weeks
|
• Quality of life will be measured using the King's Health Questionnaire
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From enrollment to the end of treatment at 12 weeks
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Мужские мочеполовые заболевания
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Нарушения мочеиспускания
- Симптомы нижних мочевыводящих путей
- Урологические проявления
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Недержание мочи
Другие идентификационные номера исследования
- University of Tabuk (UTabuk)
Планирование данных отдельных участников (IPD)
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