Importance of Patient Positioning at Cough Test When Considering Success Following Sling Procedures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
研究概览
简要总结
This is a prospective study to assess the feasibility and success of performing an intra-operative standing cough test and the correlation with the long term success of the sling surgery.
详细描述
The goal is to seek correlation or disparity between the supine versus the sitting cough test, supine (lying down) versus standing cough test and sitting versus the standing cough test performed at a constant bladder volume; empty in the office and full in the operating room. Secondary objective is to test if the intra-operative standing cough test at fullness correlates with long term success of the sling surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who present with stress-dominant urinary incontinence
- •Patients who have undergone a stress test documentation both in the supine and standing/sitting position.
- •Patients who have completed child bearing.
- •Patients between 21 and 89 years of age.
排除标准
- •Patients who do not agree to participate and do not sign the informed consent.
- •Patients undergoing concomitant surgery
- •Patients undergoing surgery under anesthesia.
结局指标
主要结局
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative MESA questionnaire.
时间窗: Within first two years following sling procedure
Success criteria is also defined through the examination of patient's response to Medical Epidemiologic and Social Aspects of Aging 12 (MESA) to determine recurrence of stress incontinence. Failure to meet this criteria will be considered recurrence of stress incontinence.
Number of patients who present with recurrence of stress incontinence following sling surgery as assessed by post-operative cough test.
时间窗: Within first two years following sling procedure
Success criteria will be defined through the examination of patient's post-operative visits regarding cough stress tests in supine, sitting and standing positions where the bladder is at 10% of urodynamic fullness. Failure to meet this criteria will be considered recurrence of stress incontinence.
次要结局
未报告次要终点
研究者
Salil Khandwala MD
Medical Director
Michigan Institution of Women's Health PC