Effect of Transcranial Direct Current stimulation combined with pelvic floor muscle training on urinary incontinence in elderly women- A randomised controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Stop test
研究概览
简要总结
his randomized controlled trial aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) combined with pelvic floor muscle training (PFMT) in improving urinary incontinence among elderly women aged above 55 years. The study will be conducted at Dr. D.Y. Patil Hospital and affiliated centers in Pune, India. A total of 60 participants diagnosed with urinary incontinence will be conveniently sampled and randomly assigned to either an experimental group (tDCS + PFMT) or a control group (PFMT alone), with 30 participants in each group.
The PFMT protocol consists of two phases:
- Weeks 1–2: Basic training with slow contractions (3 sec hold, 6 sec relax) and quick contractions (rapid squeeze-release), 5 repetitions × 2 sets each.
- Weeks 3–4: Progressed exercises including sustained holds (8–10 sec), assisted rolling rotation, and assisted bridging exercises, each for 5 repetitions × 2 sets.
Outcome measures include the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), 1-hour pad test, Stop test, and Incontinence Impact Questionnaire (IIQ-7). The primary goal is to assess the difference in symptom severity, urinary leakage, pelvic floor strength, and quality of life between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 60.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Age 60 years and above elderly women: Participants should be older adults to target the geriatric population.
- •Diagnosis of urinary incontinence: Participants should have a clinical diagnosis of stress urinary incontinence, urge urinary incontinence, or mixed urinary incontinence.
- •Women who scores more than 2 on Incontinence Severity Index.(ISI) .
- •4.Participants should be able to understand and perform simple exercises with guidance.
- •5.Womens who can follow simple commands.
排除标准
- 未提供
结局指标
主要结局
Stop test
时间窗: Baseline Assessment and Post Intervention assessment after 4 weeks
International Consultation on Incontinence Questionnaire-Short Form
时间窗: Baseline Assessment and Post Intervention assessment after 4 weeks
.Incontinence Impact questionnaire-7(IIQ-7)
时间窗: Baseline Assessment and Post Intervention assessment after 4 weeks
1-hour pad test
时间窗: Baseline Assessment and Post Intervention assessment after 4 weeks
次要结局
未报告次要终点
研究者
Sanika Aherkar
Dr. D. Y. Patil College of Physiotherapy