NCT01672190已完成不适用
Lessening Incontinence by Learning Yoga
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
研究概览
简要总结
The purpose of this study is to assess the feasibility of recruiting women with urinary incontinence into a randomized controlled trial of a yoga therapy program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 40 years or older who report urinary incontinence for > 3 months prior to screening
- •Self-report at least 7 urinary incontinence episodes per week on a screening 7-day voiding diary
- •Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the screening voiding diary
- •Willing to refrain from initiating medical treatments that may affect their incontinence or voiding pattern during the study period
- •Capable of understanding study procedures and giving informed consent
排除标准
- •Participation in a yoga class or other formal or organized yoga instruction in the past year
- •Any prior yoga therapy directed specifically at improving urinary incontinence or pelvic floor dysfunction
- •Current use of medical therapy or device (i.e. pessary) for incontinence or use within the previous month
- •Currently pregnant, gave birth within the past 6 months, or planning pregnancy during the study period
- •Current urinary tract infection or a history or 3 or more urinary tract infections in the preceding year
- •Report history of neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with neurological symptoms
- •Unable to walk up a flight of stairs or at least 2 blocks on level ground without assistance
- •Unable to get up from a supine to a standing position in 10 seconds or less and without assistance
- •Severe obesity, defined as body mass index > 35 kg/m2 on screening examination
- •Report history of interstitial cystitis, fistula or hole in bladder or rectum, or birth defect leading to urine leakage
- •Report any history of prior anti-incontinence or urethral surgery (not including urethral dilation), pelvic cancer, or pelvic irradiation for any reason
- •Report use of bladder botox, electrostimulation, bladder training, or pelvic floor exercise training (with certified practitioners) in the past 3 months
- •Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery, bladder surgery, colon surgery) within the past 3 months
- •Report symptomatic pelvic organ prolapse
- •Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic floor exercises
- •Report conditions that, in the judgment of the investigators, render potential participants unlikely to follow the protocol, including plans to move, substance abuse, significant psychiatric problems, or dementia
- •Participation in another research study that involves investigational drugs or devices that could potentially confound the results of this study
结局指标
主要结局
Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Alison Huang
Assistant Professor
University of California, San Francisco
研究点 (2)
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