Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

Ejaculatory Dysfunction Clinical Trial

Official title:

Study of the Biomechanical Anatomy of Ejaculation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05650853
• Other study ID #: 2022-A01594-39
• Status: Completed
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: January 9, 2023

Study information

• Verified date: January 2023
• Source: Clinique Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ejaculatory Dysfunction

Intervention

Other:
• Transrectal ultrasound
Examinations for observation of the pre, per and post-ejaculatory phases
• Urethroscopy
Examinations for observation of the pre, per and post-ejaculatory phases

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-urethral muscle contraction	Qualitative description of peri-urethral muscle contraction according to ultrasound videos analysis	At Day 0
Primary	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
Primary	Sperm flow within the prostatic urethra	Qualitative description of sperm flow within the prostatic urethra according to ultrasound videos analysis	At Day 0
Primary	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
Primary	Veru montanum mobility and urethral contraction.	Qualitative description of veru montanum mobility and urethral contraction according to urethroscopy videos analysis	At Day 6