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临床试验/NCT05650853
NCT05650853已完成不适用

Study of the Biomechanical Anatomy of Ejaculation

Clinique Pasteur1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2022年12月12日最近更新:
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
3
试验地点
1
主要终点
Veru montanum mobility and urethral contraction.

研究概览

简要总结

Ejaculatory dysfunctions (ED) are an important cause of postoperative dissatisfaction, which lead to a decrease in the intensity of orgasms in 50% of patients. ED is a cause for concern for almost a third of patients who need surgery. Surgical techniques have been developed to limit the occurrence of postoperative ED, but their results remain heterogeneous.

There are very few studies on the biomechanical anatomy of ejaculation. Ejaculation is a complex phenomenon involving different structures and in particular the Veru Montanum. This is the key element in the emission of ejaculate within the prostatic urethra. In addition, there is a structure located in the resection zone of the prostate adenoma. It has therefore been suggested that its resection was a primary source of ED.

A single observational study carried out in by Gil Vernet et al in 1994 evaluated on a single healthy 18-year-old volunteer the ejaculatory mechanism of expulsion using an endorectal probe recording the movements of the prostate, the bladder neck and of the proximal urethra during ejaculation.

A contemporary study of the biomechanics of the ejaculatory expulsion phase could confirm and improve understanding of the involvement of anatomical structures. The results of our study aim to adapt surgical techniques aimed at limiting the risk of postoperative ED.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
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
是

入选标准

  • •Affiliated subject or beneficiary of a social security scheme
  • •Subject agreeing to participate and having signed the free, informed consent.

排除标准

  • •Subject with ejaculatory dysfunction
  • •Subject with urinary dysfunction
  • •History of urinary or penile surgery
  • •Subject with untreated urinary tract infection
  • •History of chronic prostatitis
  • •Pathology making it impossible to introduce the endorectal probe or the ureteroscope
  • •History of colorectal inflammatory disease
  • •Recent intake (within 30 days) of drugs known to interfere with ejaculation
  • •History of intolerance or allergy to any of the drugs used in the study
  • •Subject participating in another clinical study
  • •Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; Hospitalized without consent.

研究组 & 干预措施

Study intervention

Experimental

Transrectal ultrasound and Urethroscopy

干预措施: Transrectal ultrasound (Other)

Study intervention

Experimental

Transrectal ultrasound and Urethroscopy

干预措施: Urethroscopy (Other)

结局指标

主要结局

Veru montanum mobility and urethral contraction.

时间窗: At Day 6

Qualitative description of veru montanum mobility and urethral contraction according to urethroscopy videos analysis

Peri-urethral muscle contraction

时间窗: At Day 0

Qualitative description of peri-urethral muscle contraction according to ultrasound videos analysis

Sperm flow within the prostatic urethra

时间窗: At Day 0

Qualitative description of sperm flow within the prostatic urethra according to ultrasound videos analysis

Spermatic fluid via the ejaculatory ducts

时间窗: At Day 6

Qualitative description of the expulsion and flow of spermatic fluid via the ejaculatory ducts according to urethroscopy videos analysis

Urethra, bladder neck and prostate movements

时间窗: At Day 0

Qualitative description of movements of the urethra, bladder neck and prostate according to ultrasound videos analysis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Dr Vincent Misrai

Principal Investigator, MD

Clinique Pasteur

研究点 (1)

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