NCT07105150招募中不适用
Efficacy of an Educational Video-Based Program to Treat Urinary Incontinence in Women Referred for Pelvic Floor Rehabilitation
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 12
- 主要终点
- Urinary incontinence score comparison between the 2 groups
研究概览
简要总结
The aim of this clinical trial is to assess the effectiveness of a 4-week video-based education program in enhancing urinary continence among women with urinary incontinence referred for pelvic floor rehabilitation
The main question it aims to answer is :
• Does a structured video-based education program reduce the symptoms of urinary incontinence before any pelvic floor muscle strengthening ? Researchers will compare this program to a paper document (providing similar information) to see if this improves urinary continence in women suffering from urinary incontinence.
Participants will :
- receive either the video-based education program or a paper information document (providing similar information) prior to the sessions with the physiotherapist
- then follow pelvic floor rehabilitation sessions with the physiotherapist according to usual practice
- complete the urinary incontinence questionnaire after the 4-week video education program (intervention group) or 4 weeks after receiving the paper document (control group), and after each pelvic floor rehabilitation session with the physiotherapist and at the end of the sessions
- will be monitored at 1 and 2 years to evaluate urinary incontinence following the intervention.
详细描述
The video-based education program will include 4 workshops of 20 minutes each, at a rate of 1 video per week:
Video 1: Anatomy and physiology of the pelvic floor; Video 2: Physiology of the urinary tract; Video 3: Physiology of the digestive tract; Video 4: Pathophysiology of urinary incontinence and other pelvic floor disorders (genital prolapse and anal incontinence) and preventive measures in daily activities.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Any woman referred for pelvic floor rehabilitation sessions for urinary incontinence (defined as 'any involuntary leakage reported by the patient' according to the International Continence Society)
- •Women requiring perineal rehabilitation for urinary incontinence
- •Aged 18 years or older
- •Having access to a connected device (tablet, smartphone, computer)
- •Having a functional email address
- •Covered by a social security scheme
- •Informed, and written consent (signed by the participant and the investigator)
排除标准
- •Women unable to complete questionnaires (unable to read French or unable to write)
- •Visually impaired individuals who cannot watch the video or read the printed material
- •Genital prolapse extending beyond the hymen
- •Documented neurological disorders
- •Individuals receiving psychiatric care and those unable to express their consent
- •History of pelvic fractures or dorsolumbar surgery
- •Chronic pelvic pain
- •Women who have given birth within the last 6 month
- •Individuals with enhanced protection: minors, individuals deprived of liberty, individuals residing in a health or social institution, pregnant or breastfeeding women, adults under legal protection, and patients in emergency situations.
研究组 & 干预措施
video-based education program group
Experimental
干预措施: video-based education program (Behavioral)
written information group
Active Comparator
干预措施: written information (Other)
结局指标
主要结局
Urinary incontinence score comparison between the 2 groups
时间窗: At the end of the video-based education program (5 weeks after inclusion)
the urinary incontinence score will measured using the ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form), ranging from 0 (corresponding to 'no urinary incontinence') to 21 (corresponding to 'very severe urinary incontinence'), collected after the video-based education program in the intervention group (scheduled over 4 weeks) and within the same timeframe in the control group (which received only the information document)
次要结局
- Urinary incontinence score evolution in the intervention group(from inclusion until the end of the video education program (5 weeks after inclusion))
- Urinary incontinence score evolution in the control group(from inclusion to 5 weeks following the distribution of the paper information document)
- Number of pelvic floor rehabilitation sessions required in the intervention group(ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months)
- Number of pelvic floor rehabilitation sessions required in the control group(ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months)
- Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the intervention group(ICIQ-SF score recorded after each pelvic floor rehabilitation session, through end of rehabilitation, an average of 3 months)
- Urinary incontinence score evolution during the pelvic floor rehabilitation sessions in the control group(ICIQ-SF score recorded after each pelvic floor rehabilitation sessions, through end of rehabilitation, an average of 3 months)
- Quality of life score evolution in the intervention group(at inclusion and after the video-based education program (5 weeks after inclusion) , as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Quality of life score evolution in the control group(at inclusion and 5 weeks after the distribution of the paper document information, as well as between inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Pelvic floor and sexual symptoms scores evolution in the intervention group(between inclusion and the end of the video-based education program (5 weeks after inclusion), as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Pelvic floor and sexual symptoms scores evolution in the control group(at inclusion and 5 weeks after the distribution of the paper information document, as well as between inclusion and the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Patient-perceived improvement score evolution in the control group(5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Patient-perceived improvement score evolution in the intervention group(after the video-based education program (5 weeks after inclusion)and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Patient-perceived improvement score evolution according to the urinary incontinence type in the intervention group(after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months))
- Patient-perceived improvement score evolution according to the type of urinary incontinence(5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the intervention group(after the video-based education program (5 weeks after inclusion) and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- ICIQ-SF score evolution 12 and 24 month after the end of the pelvic floor rehabilitation sessions in the intervention group(at the end of the pelvic floor rehablitation sessions and after 12 and 24 months)
- Patient-perceived improvement score evolution according to the dimensions of the Urinary Leakage Circumstances questionnaire in the control group(5 weeks after inclusion and at the end of the pelvic floor rehabilitation sessions, an average of 3 months)
- ICIQ-SF score evolution at 12 and 24 months after the end of the pelvic floor rehabilitation sessions(at the end of the pelvic floor rehablitation sessions and after 12 and 24 months)
- Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the intervention group(at 12 and 24 months)
- Urinary incontinence management 12 and 24 months after the end of the pelvic floor rehabilitation sessions in the control group(at 12 and 24 months)
- Impact of the videos on Knowledge and Satisfaction Ratings(after each video of the program, once a week for 4 weeks)
- Usage of the videos provided in the intervention group(at the end of the video-based education program, 5 weeks after inclusion)
- Physical activity evolution after pelvic floor rehabilitation in the entire population and afetr 12 and 24 months(from inclusion to the end of the pelvic floor rehabilitation sessions (an average of 3 months), and after 12 and 24 months after the end of rehabilitation)
- Urinary incontinence score between the 2 groups according the UI type(at the end of the video-based education program versus the paper information document, 5 weeks after inclusion)
- Urinary incontinence score according to the dimensions of the Urinary Leakage Questionnaire(after the video-based education program, 5 weeks after inclusion)
研究者
研究点 (12)
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