Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative
研究概览
简要总结
This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place.
Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse.
详细描述
Investigators will conduct a prospective, randomized, noninferiority trial on patients undergoing retropubic midurethral sling (RP MUS) placement at the time of robotic-assisted sacrocolpopexy (RSC).
Patients scheduled to undergo retropubic midurethral sling placement at the time of robotic- assisted sacrocolpopexy will be invited to participate during regularly scheduled preoperative visits with their urogynecologic provider. Participants will be randomized to receive RP MUS before RSC or after RSC. Randomization will be conducted in RedCap. Randomization will be performed using a variable permutated block randomization scheme. The Randomization window will be +/- 4 days before their scheduled surgery, and patients will be blinded to sequence of MUS placement intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •At least 18 years of age
- •Able to speak and read English and Spanish
- •Diagnosis of pelvic organ prolapse stage 2-4
- •Planning to undergo a robotic-assisted sacrocolpopexy
- •Demonstrable SUI (either by CST, with or without prolapse reduction, or UDS) within the year prior to enrollment
- •Planning to undergo concomitant SUI correction with MUS at the time of RSC
排除标准
- •Less than 18 years of age
- •Unable to speak and read English or Spanish
- •No diagnosis of SUI (prophylactic slings)
- •History of prior surgery for SUI
- •Bladder capacity <200 mL or post-void residual (PVR) >150 mL
- •Current genitourinary fistula or urethral diverticulum
研究组 & 干预措施
Midurethral sling placed before robotic sacrocolpopexy
Midurethral sling placed after robotic sacrocolpopexy
干预措施: Midurethral sling placed before robotic sacrocolpopexy (Procedure)
Midurethral sling placed after robotic sacrocolpopexy
干预措施: Midurethral sling placed after robotic sacrocolpopexy (Procedure)
结局指标
主要结局
Urinary Distress Index, Short Form (UDI-6) scores at 3 months postoperative
时间窗: 3 months
The primary outcome will be change between baseline and 3 months stress urinary incontinence symptoms as measured by the UDI-6. Scores for the UDI-6 range from 0 to 100 has an MCID of 5.8, with higher scores indicating worse symptoms.
次要结局
- Provocative stress test results at 6 weeks postoperative(6 weeks)
- Need for re-treatment for stress urinary incontinence (SUI) at 6 weeks postoperative(6 weeks)
- Change in total Pelvic Organ Prolapse/Incontinence Sexual Questionnaire (PISQ-IR) at 3 months postoperative(3 months)
- Change in total Incontinence Impact Questionnaire, Short Form (IIQ-7) scores at 3 months postoperative(3 months)
- Complications (graded as Clavien Dindo)(6 weeks)
- Objective surgical data such as operative time(6 weeks)
- Objective surgical data such as estimated blood loss (EBL)(6 weeks)
- Patient satisfaction (a decision scale and decision regret scale)(3 months)
- Patient satisfaction (Patient Global Impression of Improvement (PGI-I) for Incontinence)(3 months)
研究者
Gabriela Halder
Assistant Professor
University of Alabama at Birmingham