Robotic Sacrocolpopexy Versus High Uterosacral Ligament Suspension: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
研究概览
简要总结
The purpose of this study is to compare the effectiveness of R-SCP versus HUSLS for treatment of pelvic organ prolapse.
详细描述
To compare the effectiveness of Robotic Sacrocolpopexy versus vaginal High Uterosacral Ligament Suspension for treatment of pelvic organ prolapse. Both surgeries are standard of care and are equally and widely used throughout the country with well known safety and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 Years of age or older
- •Signed Informed Consent
- •Symptomatic pelvic organ prolapse,
- •Willing and able to complete all study visit
排除标准
- •Non-High Uterosacral Ligament Suspension (unable to do HUSLS at time of surgery),
- •Dementia or considered unable to complete questionnaires
- •Hx of Alzheimer Disease
- •Hx multiple strokes or other neurologic condition
- •Caregiver states the subject is unable to complete
- •MDs opinion
- •Inability to complete follow up visits due to transportation issues
- •No access to transportation (ie. does not have vehicle)
- •Live > 2 hours from LLUH
- •Does not have financial means
- •Congenital anomalies
- •Bladder Exstrophy
- •Connective tissue disease
- •Neovaginal prolapse
- •Prolapse of sex change vagina
- •Chronic pelvic pain
- •> 6 months of pelvic pain of undetermined origin
- •not cyclic pain (eg. period pain or dysmenorrhea)
- •Patient has comorbidities of CPP
- •Fibromyalgia
- •Interstitial cystitis
- •Contraindications to Mesh,
- •Opposition to the use mesh (ie. due to religious beliefs)
- •History of mesh complications in past
- •Pregnant or planning to become pregnant during the study period.
研究组 & 干预措施
Sacrocolpopexy
Robotic sacrocolpopexy
干预措施: Robotic sacrocolpopexy (Procedure)
HUSLS
Vaginal high uterosacral ligament suspension
干预措施: high uterosacral ligament suspension (Procedure)
结局指标
主要结局
Pelvic Organ Prolapse Quantification (pop-q) to asses change post operatively
时间窗: 12 month post operative
Pelvic organ prolapses are graded with the Pelvic Organ Prolapse Quantification (POP-Q) System.
次要结局
- questionnaires PISQ-12(12 month post operative)
- questionnaires PFIQ-20(12 month post operative)
- questionnaires PGI-I(12 month post operative)
- questionnaires PFDI-7(12 month post operative)