A Randomized Controlled Trial Comparing Pilates, Pilates Combined With Voluntary Pelvic Floor Muscle Contraction, and Isolated Pelvic Floor Muscle Training for the Treatment of Stress Urinary Incontinence in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change in International Consultation on Incontinence (ICIQ-SF) total score
研究概览
简要总结
This assessor-blinded randomized controlled trial aims to compare the effectiveness of three exercise programs for the treatment of stress urinary incontinence (SUI) in women: (1) Pilates without voluntary pelvic floor muscle contraction, (2) Pilates combined with voluntary pelvic floor muscle contraction, and (3) isolated pelvic floor muscle training (PFMT).
Seventy-eight women aged over 18 years with self-reported SUI are randomly allocated into three parallel groups. Interventions last 6 weeks, with two sessions per week (12 sessions).
The primary outcome is the change in the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) score from baseline to post-intervention. Secondary outcomes include urinary frequency and leakage episodes (72-hour bladder diary), pelvic floor muscle strength (Modified Oxford Scale), endurance, rapid contractions, and vaginal squeeze pressure measured by perineal manometry (Peritron).
The hypothesis is that Pilates combined with voluntary pelvic floor muscle contraction will be superior to Pilates alone and comparable or superior to isolated PFMT.
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 (Investigator)
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
- •Women ≥18 years
- •Self-reported stress urinary incontinence
- •Positive response to stress-related leakage question
排除标准
- •Inability to read/respond to questionnaires
- •Urinary tract infection within last 2 weeks
- •Current smoking
- •Previous pelvic surgery (except cesarean section)
- •Previous pelvic radiotherapy
- •Neurological disease
- •Pelvic floor muscle strength grade 0-1 (Modified Oxford Scale)
- •Pregnancy or <3 months postpartum
研究组 & 干预措施
Arm 1 - Pelvic floor muscle training
Intervention: Behavioral: Pelvic Floor Muscle Training Participants perform isolated pelvic floor muscle exercises in supine, sitting, and standing positions, including sustained and rapid contractions, twice weekly for 12 session. Stretching and mobility exercises are performed during rest intervals.
干预措施: Pelvic Floor Muscle Training (Other)
Arm 2 - Pilates group
Intervention: Other: Pilates Exercise Program Participants perform mat and equipment-based Pilates exercises (Reformer, Chair, Cadillac) for 6 weeks, twice weekly - 12 session. Exercises are performed in three progressive phases (8-10-12 repetitions, 3 sets). Abdominal contraction is requested during expiration to activate the "powerhouse," without voluntary pelvic floor muscle contraction instruction.
干预措施: Pilates Exercise Program (Other)
Arm 3 - Pilates + pelvic floor contraction
Intervention: Other: Pilates With Voluntary Pelvic Floor Muscle Contraction Same protocol as the Pilates group; however, participants are instructed to perform simultaneous voluntary pelvic floor muscle contraction during each expiratory phase.
干预措施: Pilates With Voluntary Pelvic Floor Muscle Contraction (Other)
结局指标
主要结局
Change in International Consultation on Incontinence (ICIQ-SF) total score
时间窗: Baseline and 6 weeks
Difference in total score from baseline to post-intervention. Higher scores indicate worse urinary incontinence impact.
次要结局
- Change in urinary leakage episodes (72-hour bladder diary)(Baseline and 6 weeks)
- Change in Pelvic Floor Muscle Strength (Modified Oxford Scale, 0-5)(baseline and 6 weeks)
研究者
Ana Paula Magalhães Resende
Professor, PT, PhD
Federal University of Uberlandia