Ambulatory Pessary Trial as a Preoperative Method for Diagnosing Occult Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Overactive bladder quality of life (QAB-Q)- short term questionnaire
研究概览
简要总结
The purpose of this study is to compare two methods for assessing patients with pelvic organ prolapse for occult stress urinary incontinence. Urodynamic testing is the most widely accepted and well-studied method for diagnosing occult stress urinary incontinence preoperatively, but an ambulatory pessary trial is a less expensive option that is available to a wider group of practitioners and evaluates patient while they are engaged in their daily activities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Patients planning to undergo pelvic organ prolapse surgery and preoperative urodynamic testing within 6 months of recruitment.
- •Stage 2 or greater pelvic organ prolapse on pre op POP-Q exam
- •Negative stress test on clinical exam
- •Cognitive capacity to complete questionnaires and voiding diary
排除标准
- •Stress incontinence during provocative stress test on pre-operative exam.
- •Occult stress urinary incontinence demonstrated on pre-operative physical exam
- •Known ability to retain a pessary for the 3 day trial
- •< age 18
- •History of bladder augmentation or artificial sphincter
- •Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
- •Non ambulatory patients
- •Active infections of the vagina or pelvis (Pelvic inflammatory disease, infectious vaginitis, etc.)
- •Occult stress urinary incontinence demonstrated on pre-operative physical exam
- •Known ability to retain a pessary for the 3 day trial
- •< age 18
- •History of bladder augmentation or artificial sphincter
- •Known neurologic disease effecting bladder (spinal cord injury, Multiple Sclerosis, Parkinson's Disease, etc.)
- •Non ambulatory patients
- •Active infr
研究组 & 干预措施
Urodynamics, followed by Pessary
干预措施: Urodynamics (Device)
Urodynamics, followed by Pessary
干预措施: Pessary (Device)
Pessary, followed by Urodynamics
干预措施: Urodynamics (Device)
Pessary, followed by Urodynamics
干预措施: Pessary (Device)
结局指标
主要结局
Overactive bladder quality of life (QAB-Q)- short term questionnaire
时间窗: 3 days
Medical, Epidemiological, and social Aspects of Aging (MESA) questionnaire
时间窗: 3 Days
leakage on a voiding diary.
次要结局
未报告次要终点