NCT00937833已完成不适用
Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of Continent Patients Post Prostatectomy
研究概览
简要总结
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
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
- 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
- •Patients must have organ confined prostate cancer.
- •Patients must have PSA<
- •Patients must have clinical stage prostate cancer < cT
- •Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
- •Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
- •Patients must be at least 18 years of age.
排除标准
- •Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
- •Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
- •Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
- •Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
- •Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than
- •Patients must not have a prior history of radiation to the pelvis.
- •Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
- •Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
研究组 & 干预措施
Urethrovesical Sling
Experimental
Surgisis Male Sling placed at the time of prostatectomy
干预措施: Prostatectomy (Procedure)
Urethrovesical Sling
Experimental
Surgisis Male Sling placed at the time of prostatectomy
干预措施: Surgisis Male Sling (Device)
Control
Active Comparator
Prostatectomy
干预措施: Prostatectomy (Procedure)
结局指标
主要结局
Number of Continent Patients Post Prostatectomy
时间窗: 1 Month
次要结局
未报告次要终点
研究者
研究点 (2)
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