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临床试验/NCT02591381
NCT02591381终止不适用

A Randomized Study of Transcorporal Versus Standard Artificial Urinary Sphincter Placement

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
2
主要终点
Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy

研究概览

简要总结

The investigators propose a randomized non-blinded comparison of standard vs. transcorporal approach for placement of an artificial urinary sphincter in male patients with stress urinary incontinence after radiation and radical prostatectomy for prostate cancer. In the United States, the artificial urinary sphincter (AUS), manufactured by American Medical Systems, is the gold standard surgical treatment for stress urinary incontinence (SUI) in men. The cuff, which is the portion of the device that encircles and occludes the urethra, is typically placed directly around the urethra (i.e., "standard" placement). The cuff can erode into the urethra. Transcorporal placement has been introduced as a method to reduce the risk of erosion. Transcorporal placement involves tunneling the cuff through the erectile bodies so as to protect the dorsal aspect of the urethra. This approach has never been compared to standard placement in a randomized fashion. In the randomized trial, no additional procedures beyond the normal care protocol will be required of the patients. The investigators will conduct the study through an established, IRB-approved multi-institutional network of surgeons. Success will be assessed via objective and subjective methods; complications will be tallied in a standardized fashion. Outcomes will be measured at two years.

详细描述

Procedure/ Methods:

Patients will be identified in the urology clinic upon their standard of care visit for AUS placement. The procedures that determine whether a patient is a surgical candidate are as follows:

  • Incontinence Impact Questionnaire Short Form (IIQ-7) and Urinary Incontinence Symptoms index (ISI) standardized questionnaires
  • Physical examination
  • Review of medical history that would preclude surgery
  • Cystoscopy to evaluate and rule out stricture
  • Uroflow/Post void residual to ensure adequate bladder capacity

Pre surgery work up includes:

  • Urine analysis and if indicated urine culture and treatment of urinary tract infection
  • Flow, post-void residual if possible
  • Cystoscopy to rule out bladder neck contracture or urethral stricture
  • History and physical examination
  • Treatment of men with 2 days of chlorhexidine wash to the perineum
  • Incontinence sexual function questionaires
  • Aminogllycoside and other abx prior to surgery
  • 24 hour pad weight

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • All patients undergoing an AUS procedure would potentially be candidates for the study

排除标准

  • There are several situations in which either a TC or ST procedure would be specifically indicated, and it would be unethical to randomize these patients to the other procedure.
  • No men without erectile dysfunction
  • No use of injectable agents into the corporal body
  • No prior urethral surgery (Prior surgery defined as; urethroplasty, urethral sling, prior AUS placement or explantation, recto-urethral fistula closure)
  • No current penile prosthesis
  • No concomitant placement of penile prosthesis at the time of AUS placement
  • Males under the age of 18, as well as females, are also excluded

结局指标

主要结局

Revision or removal surgery for AUS cuff problems other than mechanical failure: these include cuff erosion, impending erosion (discretion of surgeon), persistent retention due to small cuff, urethral atrophy

时间窗: Through study completion, an average of up to 1 year

次要结局

  • Quality of Life impact as measured by the Incontinence Impact Questionnaire--Short Form (IIQ)(3 month post op, 12 month post op)
  • Change in 24 hour pad test at 3 months post-op compared to pre-op(3 months post op)
  • Erectile function as measured pre and post AUS placement via the Sexual Health Inventory for Men (SHIM)(3 month post op, 12 month post op)
  • Rate of post-operative urinary retention(Up to 2-4 weeks)
  • Incontinence impact as measured by the Incontinence Symptom Index (ISI)(3 month post op, 12 month post op)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Breyer, MD

Chief of Urology

University of California, San Francisco

研究点 (2)

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