CREDE Study: Intraoperative Crede Manoeuver Compared to Preoperative Prolapse Reduction Stress Test to Predict Postoperative de Novo Stress Urinary Incontinence (PONSUI) at the Time of Pelvic Organ Prolapse (POP) Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Subjective postoperative de novo stress urinary incontinence (PONSUI)
研究概览
简要总结
The CREDE pilot randomized study will compare the intraoperative Crede manoeuver (M1) to preoperative prolapse (POP) reduction cough stress test (M2) for the prediction and prevention of PONSUI. The rates of PONSUI and its effect on patient reported outcomes and quality of life will be determined among women with positive or negative tests, and those with and without concomitant anti-incontinence procedure performed. This information will help inform larger studies on the topic.
详细描述
Primary objective
- To assess feasibility of a pilot study to test this hypothesis with the goal to conduct a full trial (sample size calculation, validation of instruments used, randomization processes)
- To estimate the rate of subjective PONSUI at 6 weeks and at 6 months in continent women undergoing POP surgical repair where a positive intraoperative Crede maneuver (M1) vs. a positive preoperative prolapse reduction stress test (M2) are used to select candidates for concomitant anti-incontinence procedure (either 1. retropubic midurethral sling (MUS) or 2. periurethral bulking injections)
Secondary objectives
I. To compare the estimated rate of objective PONSUI at 6 weeks and at 6 months (as determined by cough stress test) in continent women undergoing POP surgical repair where a positive intraoperative Crede maneuver (M1) vs. a positive preoperative prolapse reduction stress test (M2) are used to select candidates for concomitant anti-incontinence procedure II. To compare the rate of urinary symptoms and the effect on quality of life at 6 weeks and 6 months between M1 and M2, by Urinary Distress Inventory (UDI-6) and Urinary Impact Questionnaire (UIQ-7) III. To describe the risk of complications in patients having either maneuvers (M1, M2), including bladder perforation, voiding dysfunction, urinary tract infection and mesh exposure IV. To assess the concordance/discordance rate of M1 and M2 to compare the predictive subjective and objective PONSUI values of both maneuvers by test results and by anti-incontinence procedure
Methodology
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Anterior, uterine or apical prolapse with a POP-Q stage II or more requiring surgical correction
排除标准
- •Stress urinary incontinence (SUI) on history
- •Previous anti-incontinence surgery
- •Pregnancy
- •Prior urethral repair surgery (diverticulum, fistula)
- •Women who do not speak or read English or French
- •Isolated posterior compartment prolapse
- •Geographic location preventing women to come to 6 week and 6 month appointments
研究组 & 干预措施
Intraoperative Crede manoeuver
Method 1 (M1) consists in intraoperative Crede maneuver: After POP surgical reduction, the bladder will be retrograde filled with 300 ml of sterile water through a catheter that will then be removed. Brief and forceful suprapubic pressure will be applied. The test is positive if the surgeon visualizes a urinary leak.
In this group, the intraoperative Crede manoeuver will determine if an anti-incontinence procedure should be performed concomitantly.
干预措施: Intraoperative Crede manoeuver (Diagnostic Test)
Preoperative prolapse reduction cough stress test
An examiner will perform the test preoperatively in the office, at the same visit as the recruitment. With a volume of 250-350 mL of urine in the bladder (confirmed by bladder scanner), a prolapse reduction cough stress test will be performed (posterior speculum blade for reduction). The test is positive if the examiner visualizes a urinary leak.
In this group, the preoperative prolapse reduction cough stress test will determine if an anti-incontinence procedure should be performed concomitantly.
干预措施: Preoperative prolapse reduction cough stress test (Diagnostic Test)
结局指标
主要结局
Subjective postoperative de novo stress urinary incontinence (PONSUI)
时间窗: 6 months
SUI occurring after a surgery (usually a prolapse correction) in a patient who did not have SUI before the surgery. In this study, PONSUI is defined as answering "yes" to question #3 in the UDI-6 questionnaire: "Do you experience urine leakage related to activity, coughing or sneezing?" after the surgery, in previously continent women.
次要结局
- Objective PONSUI(6 months)
- Urinary symptoms(6 months)
- Impact on quality of life(6 months)
- Complications(6 months)
- Prevalence and correlation of each test result(At baseline)
研究者
Maryse Larouche
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre