Randomized Trial Comparing Anterior Colporrhaphy to Paravaginal Defect Repair for Anterior Vaginal Wall Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
研究概览
简要总结
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
详细描述
It is not known whether anterior vaginal repair (colporrhaphy) or abdominal paravaginal defect repair is the procedure of choice for the treatment anterior vaginal wall prolapse. This randomized prospective study will attempt to answer this question by assessing the change in the stage of prolapse before and after surgery, patient satisfaction through quality of life and sexual function questionnaires before and after surgery, and peri-operative complication rates. Patients enrolled into the study will be followed up for up to 2 years after surgery.
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 (Outcomes Assessor)
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
- •Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.
排除标准
- •Patients with at least 2 previous prolapse surgeries
- •Patients who are pregnant or planning to have a pregnancy
研究组 & 干预措施
Anterior colporrhaphy
Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
干预措施: anterior vaginal repair (colporrhaphy) (Procedure)
Anterior colporrhaphy
Anterior vaginal wall colporrhaphy (repair) for cystocele (dropped bladder)
干预措施: abdominal paravaginal defect repair (Procedure)
Paravaginal defect repair
Abdominal paravaginal defect repair cystocele (dropped bladder)
干预措施: anterior vaginal repair (colporrhaphy) (Procedure)
Paravaginal defect repair
Abdominal paravaginal defect repair cystocele (dropped bladder)
干预措施: abdominal paravaginal defect repair (Procedure)
结局指标
主要结局
Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
时间窗: 4 years
POP-Q (pelvic organ prolapse quantification) as measured after surgery at one year or more after surgery. If one year data not available, then the last post-op measure is reported.
次要结局
- The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse.(4 years)