Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

Study of the Biomechanical Anatomy of Ejaculation

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.

Study Overview

• Status: Completed
• Conditions: Ejaculatory Dysfunction
• Intervention / Treatment: Other: Transrectal ultrasound; Other: Urethroscopy

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vincent Misraï, MD; Phone Number: +33 5 62 21 33 26; Email: vmisrai@clinique-pasteur.com

Study Locations

• France
  • Toulouse, France
    • Clinique PASTEUR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study intervention; Transrectal ultrasound and Urethroscopy	Other: Transrectal ultrasound; Examinations for observation of the pre, per and post-ejaculatory phases; Other: Urethroscopy; Examinations for observation of the pre, per and post-ejaculatory phases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-urethral muscle contraction	Qualitative description of peri-urethral muscle contraction according to ultrasound videos analysis	At Day 0
Urethra, bladder neck and prostate movements	Qualitative description of movements of the urethra, bladder neck and prostate according to ultrasound videos analysis	At Day 0
Sperm flow within the prostatic urethra	Qualitative description of sperm flow within the prostatic urethra according to ultrasound videos analysis	At Day 0
Spermatic fluid via the ejaculatory ducts	Qualitative description of the expulsion and flow of spermatic fluid via the ejaculatory ducts according to urethroscopy videos analysis	At Day 6
Veru montanum mobility and urethral contraction.	Qualitative description of veru montanum mobility and urethral contraction according to urethroscopy videos analysis	At Day 6

Collaborators and Investigators

• Sponsor: Clinique Pasteur
• Investigators: Study Director: Benjamin Pradère, MD, Clinique La Croix du Sud; Study Director: Eric Bruguière, MD, Clinique PASTEUR; Study Director: Vincent Misraï, MD, Clinique PASTEUR

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): January 9, 2023
• Study Completion (Actual): January 9, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A01594-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No