The Effect of Vesicopexy on Urinary Continence and Quality of Life Following Robotic-Assisted Radical Prostatectomy: A Phase III Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- 3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
研究概览
简要总结
This phase III trial compares the effects of robot-assisted radical prostatectomy (RARP) with or without vesicopexy on urinary continence (a person's ability to control their bladder) and quality of life in patients with cancer of the prostate. RARP is the most adopted surgical approach for treatment of prostate cancer that has not spread to other places in the body (non-metastatic). Urinary incontinence (inability to control the bladder) is one of the most common complications of RARP, impacting patients' quality of life and psychological well-being. Different techniques have been proposed to improve urinary continence following RARP. Vesicopexy is one technique that restores the bladder to its normal position in the body after RARP. This study aims to evaluate whether RARP with vesicopexy may improve urinary continence and quality of life after surgery in prostate cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. To determine the 3-month (+/- 3 weeks) urinary continence following RARP with or without vesicopexy.
SECONDARY OBJECTIVES:
I. To evaluate the 3-month (+/- 3 weeks) quality of life following RARP with or without vesicopexy.
II. To evaluate the 72-hour post-operative (postop) urinary continence following RARP with or without vesicopexy.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with age > 18 years
- •Prostate cancer patients undergoing RARP with anterior approach at University of Southern California (USC) urology
- •Ability to understand and the willingness to sign a written informed consent
- •Clinical stage < 4 and (M0) prostate cancer
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-1
- •Pre-operative (op) urinary continence
- •Negative history of pelvic radiation and/or previous local therapy for prostate cancer (i.e., radiation or focal therapy)
排除标准
- •Any history of psychiatric, neurologic or cognitive disease
- •Any history of neuropathic bladder
- •Any drug or alcohol addiction
研究组 & 干预措施
Arm II (radical prostatectomy)
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Questionnaire Administration (Other)
Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Quality-of-Life Assessment (Other)
Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Questionnaire Administration (Other)
Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Radical Prostatectomy (Procedure)
Arm I (radical prostatectomy, vesicopexy)
Patients undergo standard RARP with anterior approach plus vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Vesicopexy (Procedure)
Arm II (radical prostatectomy)
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Quality-of-Life Assessment (Other)
Arm II (radical prostatectomy)
Patients undergo standard RARP with anterior approach without vesicopexy. Urethral catheters are removed 7-14 days following surgery at provider discretion.
干预措施: Radical Prostatectomy (Procedure)
结局指标
主要结局
3-month (+/- 3 weeks) urinary continence rate following RARP with or without vesicopexy
时间窗: 3 months post-operative
Defined continence as 0-1 safety pad usage. Use the "pictorial pad usage questionnaire."
次要结局
- 90-day post-operative complications(90 days post-operative)
- 72-hour postop urinary continence following surgery(72 hours post-operative)
- Operative time(Duration of operation)
- 1-month (+/- 1 week) post-operative urinary continence following surgery(1 month post-operative)
- Intra-operative complications(Duration of operation)
- 3-month (+/- 3 weeks) quality of life following surgery(3 months post-operative)
- Sexual function at 3-month (+/- 3 weeks) following surgery(3 months post-operative)