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临床试验/NCT03176017
NCT03176017Unknown不适用

Ejaculatory Sparing Transurethral Incision Of The Prostate (ES-TUIP) Versus Conventional TUIP

Mansoura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception

研究概览

简要总结

In this study, Investigators planned to compare ejaculatory sparing and non-ejaculatory sparing (conventional) TUIP using both subjective and objective assessment tools for the degree of deobstruction.

Furthermore, the impact of both techniques on ejaculation and its secondary effect on orgasm perception and different domains of sexual function will be thoroughly assessed.

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
40 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • American society of anesthesiologists (ASA) score ≤
  • TRUS estimated prostate weight ≤ 35 grams.
  • Sexually interested and having continuous relationship with the same partner (interested).
  • Bladder outlet obstruction index (BOOI ) ≥ 20 as per pressure flow study

排除标准

  • Preoperative sexual or ejaculatory disturbances or pelvic pain syndrome
  • Neurological disorders that can affect potency and ejaculation e.g. long standing uncontrolled diabetes mellitus (DM) type 2 (> 10 years), DM type 1, cerebral stroke, Parkinsonism
  • Urodynamic changes consistent with urethropathy or detrusor hypocontractility
  • Previous pelvic surgeries or radiotherapy

研究组 & 干预措施

Ejaculatory sparing TUIP

Active Comparator

Ejaculatory sparing TUIP

干预措施: Ejaculatory sparing TUIP (Procedure)

Conventional TUIP

Placebo Comparator

regular non ejaculatory sparing TUIP

干预措施: Conventional TUIP (Procedure)

结局指标

主要结局

impact on ejaculatory function and subsequently the impact of reported ejaculatory changes on orgasm perception

时间窗: 1 year

Ejaculatory domain of Male sexual health questionnaire (Ej-MSHQ)

次要结局

  • Erectile function domains (erectile function, orgasm, desire, intercourse satisfaction and overall satisfaction)(1 year)
  • Patient reported functional urinary outcomes(1 year)
  • maximum flow rate (Q.max)(1 year)

研究者

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

Abdelwahab Hashem

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Mansoura University

研究点 (1)

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