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临床试验/NCT05735223
NCT05735223已完成不适用

A Prospective Study to Evaluate the Impact of Maximal Urethral Length Preservation Technique During Robotic Laparoscopic Prostatectomy in Terms of Continence Rates

Larkin Health System2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年9月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
试验地点
2
主要终点
Penile Length

研究概览

简要总结

After robotic prostatectomy, besides erectile function and achievement of oncological control, staying dry is also a very important desire expressed frequently by the patients. This has led to the concept of trifecta achievement after robotic prostatectomies. Hence, continence preserving prostatectomies are the order of the day today. Patient acceptance to surgery is low if the continence cannot be assured preoperatively. Many techniques have been promulgated in the last two decades.

The investigators present a novel technique of maximal urethral length preservation during surgery as an effective method of continence preservation. The investigators hypothesize that maximal preservation of urethra would lead to improved and early continence after robotic prostatectomy. The investigators also hypothesize that urethral preservation spares penile length shortening. The investigators therefore propose to prospectively evaluate penile length shortening.

While penile length change after radical prostatectomy has been studied in the past, the investigators like to assess the penile morphometric assessment following the novel technique of maximal urethral length preservation radical prostatectomy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

盲法说明

Stretched flaccid penile length (SFPL) was measured by a single male assessor at preoperative visit, and at the time of catheter removal (10 days post-surgery). The subjects were blinded to the measurements to prevent bias.

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 men undergoing robot assisted laparoscopic radical prostatectomy (RALP).

排除标准

  • Exposure to androgen deprivation therapy
  • Prior treatment for prostate cancer
  • Metastatic prostate cancer
  • History of hypospadias or urethral reconstruction
  • History of penile implant, intracorporal injections, intraurethral suppositories
  • Prior pelvic surgery. -

结局指标

主要结局

Penile Length

时间窗: 10 days post operatively

Stretched Flaccid Penile Length

次要结局

  • Urinary continence(3 months and 6 months postoperatively)

研究者

发起方
Larkin Health System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Balaji Reddy, MD

Principal Investigator

Larkin Health System

研究点 (2)

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