Augmented BLAdder NecK rEconstruction Trial for Improved Urinary Function After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- EPIC Urinary Incontinence subscale score
研究概览
简要总结
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
详细描述
A bladder neck reconstruction is a standard step in performing a radical prostatectomy. Over the years, various maneuvers to improve continence have been tried and studied including intussusception stitches and slings. Slings of various origins have been used by surgeons at the time of radical prostatectomy without consistent evidence demonstrating a benefit (vas deferens, biologic). However, use of the medial umbilical ligament to create a sling has not previously been studied in a randomized trial.
The medial umbilical ligaments are normally cut during intraperitoneal robotic-assisted laparoscopic radical prostatectomy to allow the surgeon access to the Retzius space between the bladder and pubic bone. To create a medial umbilical ligament autologous sling, the ligaments are dissected out and wrapped around the vesicourethral anastomosis.
The investigators are conducting a prospective, randomized trial to investigate whether patients randomized to receive an augmented bladder neck reconstruction (aBNR) at the time of robotic-assisted laparoscopic prostatectomy experience improved urinary function post-operatively compared to patients who undergo prostatectomy with a standard BNR. An aBNR here consists of the autologous medial umbilical ligament sling as well as a bladder neck intussusception stitch. The standard BNR group will receive the intussusception stitch only.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The surgeon will be masked until the time of bladder neck reconstruction during the radical prostatectomy.
入排标准
- 年龄范围
- 40 Years 至 70 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 40 to 70 years of age with localized prostate cancer (clinical stage T2c or less, Gleason grade 5+5=10 or less without any evidence of distant metastases)
- •Scheduled to undergo curative robot-assisted radical prostatectomy
排除标准
- •Planned pre-operative or post-operative (within 1 month) androgen therapy
- •Planned pre-operative or post-operative (within 1 month) radiation therapy
- •History of spinal trauma or surgery to the brain or spinal cord
- •Pre-operative history of stress urinary incontinence
结局指标
主要结局
EPIC Urinary Incontinence subscale score
时间窗: 1 Month
Score of 0-100 on questionnaire with higher scores reflecting better health-related quality of life related to urinary incontinence (closer to 0 is more incontinence, closer to 100 is less incontinence).
次要结局
- EPIC Urinary Incontinence subscale score(12 Months)
