Effect of Lumbopelvic Rehabilitation Using Posturography Combined With Pelvic Floor Training on Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
研究概览
简要总结
The goal of this clinical trial is to evaluate whether lumbopelvic postural rehabilitation combined with pelvic floor muscle training (PFMT) is more effective than PFMT alone in women with urinary incontinence. The main questions it aims to answer are:
- Does the addition of lumbopelvic postural rehabilitation improve the severity of urinary incontinence as measured by the ICIQ-UI-SF questionnaire?
- Does it improve urinary symptom profile, pelvic floor muscle strength, patient-reported overall improvement, and quality of life compared to PFMT alone?
Participants will be randomly assigned to one of two groups:
- Experimental group (Group A): PFMT (3 sessions/week) plus lumbopelvic postural rehabilitation (2 sessions/week) for 12 weeks.
- Control group (Group B): PFMT alone (3 sessions/week) for 12 weeks. Participants will perform pelvic floor exercises in supine and seated positions, with supervised sessions at the hospital and home exercises. Postural rehabilitation includes stability and mobility exercises for the lumbopelvic region using Posturography. Outcomes will be assessed at baseline, at 6 weeks, and at 12 weeks.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged between 18 and 65 years
- •Presence of clinical signs of urinary incontinence (stress urinary incontinence and/or urge urinary incontinence and/or mixed urinary incontinence) diagnosed according to the International Continence Society (ICS) terminology
- •USP (urinary symptom profile) scores for stress urinary incontinence and/or overactive bladder ≥ 1
- •Normal neuro-perineal examination
- •Written informed consent provided prior to participation in the study
排除标准
- •Known detrusor overactivity or reduced bladder compliance of neurological origin
- •Associated voiding dysfunction, defined as a Urinary Symptom Profile (USP) dysuria subscale score ≥ 1
- •Known organic or morphological pathology of the lower urinary tract
- •Pelvic organ prolapse grade II or higher according to the Pelvic Organ Prolapse Quantification system (POP-Q)
- •Current urinary tract infection or vaginal infection
- •Cognitive or visual impairments that may interfere with understanding or performing the exercise program
- •Pregnant women or women within 10 months postpartum
- •Anticholinergic medication use or hormone replacement therapy within the last 6 months
- •Recent pelvic or abdominal surgery within the last 6 months
研究组 & 干预措施
Combined Pelvic Floor Muscle Training and Posturography Rehabilitation
Participants receive pelvic floor muscle training combined with lumbopelvic rehabilitation using posturography for a total duration of 12 weeks.
干预措施: Pelvic Floor Muscle Training (Behavioral)
Combined Pelvic Floor Muscle Training and Posturography Rehabilitation
Participants receive pelvic floor muscle training combined with lumbopelvic rehabilitation using posturography for a total duration of 12 weeks.
干预措施: Posturography Rehabilitation (Behavioral)
Pelvic Floor Muscle Training Alone
Participants receive pelvic floor muscle training alone for a total duration of 12 weeks.
干预措施: Pelvic Floor Muscle Training (Behavioral)
结局指标
主要结局
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
时间窗: 6 weeks and 12 weeks from start of intervention
The primary outcome is the severity of urinary incontinence measured by the ICIQ-UI-SF. This validated questionnaire assesses frequency, quantity, and impact of leaks on quality of life. The overall score is obtained by adding up the 3 questions, ranging from 0 to 21, with a higher score indicating more severe symptoms.
次要结局
- Patient Global Impression of Improvement (PGI-I)(6 weeks and 12 weeks from start of intervention)
- Urinary Symptom Profile (USP) scores(6 weeks and 12 weeks from start of intervention)
- Pelvic Floor Muscle Strength (Modified Oxford Scale)(6 weeks and 12 weeks from start of intervention)
- Incontinence Impact Questionnaire - Short Form (IIQ-7)(6 weeks and 12 weeks from start of intervention)
研究者
Khaoula Mestour
Resident in Physical and Rehabilitation Medicine
Mohammed V University in Rabat