Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

Sponsor

Clinique Pasteur (Other)

Overall Status

Completed

CT.gov ID

NCT05650853

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Days)

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ejaculatory Dysfunction	Other: Transrectal ultrasound Other: Urethroscopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Study of the Biomechanical Anatomy of Ejaculation

Actual Study Start Date :

Dec 12, 2022

Actual Primary Completion Date :

Jan 9, 2023

Actual Study Completion Date :

Jan 9, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Pasteur	Toulouse		France

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Vincent Misrai, Principal Investigator, MD, Clinique Pasteur

ClinicalTrials.gov Identifier:

NCT05650853

Other Study ID Numbers:

2022-A01594-39

First Posted:

Dec 14, 2022

Last Update Posted:

Jan 11, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 11, 2023