Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

NCT05650853 | Completed

• 1 other identifier: 2022-A01594-39
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Study intervention

EXPERIMENTAL

Transrectal ultrasound and Urethroscopy

Other: Transrectal ultrasound; Other: Urethroscopy

Interventions

Transrectal ultrasound OTHER

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

Study intervention

Urethroscopy OTHER

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

Study intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, France

Location

Related Publications (1)

• Pradere B, Uleri A, Bruguiere E, Misrai V. Exploration of the Ejaculatory Anatomy Concept: The EJAC Study. Eur Urol. 2025 Aug 25:S0302-2838(25)00451-8. doi: 10.1016/j.eururo.2025.08.001. Online ahead of print.

  PMID: 40858456 RESULT

MeSH Terms

Conditions

Ejaculatory Dysfunction

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Benjamin Pradère, MD

  Clinique La Croix du Sud

  STUDY DIRECTOR

• Eric Bruguière, MD

  Clinique Pasteur

  STUDY DIRECTOR

• Vincent Misraï, MD

  Clinique Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 14, 2022
• Study Start: December 12, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: March 6, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)