Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

NCT ID: NCT05650853

Last Updated: 2023-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2023-01-09

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.

Conditions

Ejaculatory Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Study intervention

Transrectal ultrasound and Urethroscopy

Group Type: EXPERIMENTAL

Transrectal ultrasound

Intervention Type: OTHER

Examinations for observation of the pre, per and post-ejaculatory phases

Urethroscopy

Intervention Type: OTHER

Examinations for observation of the pre, per and post-ejaculatory phases

Interventions

Transrectal ultrasound

Examinations for observation of the pre, per and post-ejaculatory phases

Intervention Type: OTHER

Urethroscopy

Examinations for observation of the pre, per and post-ejaculatory phases

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinique Pasteur

OTHER

Sponsor Role: lead

Responsible Party

Dr Vincent Misrai

Principal Investigator, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Pradère, MD

Role: STUDY_DIRECTOR

Clinique La Croix du Sud

Eric Bruguière, MD

Role: STUDY_DIRECTOR

Clinique Pasteur

Vincent Misraï, MD

Role: STUDY_DIRECTOR

Clinique Pasteur

Locations

Clinique Pasteur

Toulouse, , France

Countries

France

Other Identifiers

2022-A01594-39

Identifier Type: -

Identifier Source: org_study_id