Exploration of eJaculatory Anatomy Concept Study (EJAC Study)
- Conditions
- Ejaculatory Dysfunction
- Interventions
- Other: Transrectal ultrasoundOther: Urethroscopy
- Registration Number
- NCT05650853
- Lead Sponsor
- Clinique Pasteur
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3
- Affiliated subject or beneficiary of a social security scheme
- Subject agreeing to participate and having signed the free, informed consent.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study intervention Transrectal ultrasound Transrectal ultrasound and Urethroscopy Study intervention Urethroscopy Transrectal ultrasound and Urethroscopy
- Primary Outcome Measures
Name Time Method Veru montanum mobility and urethral contraction. At Day 6 Qualitative description of veru montanum mobility and urethral contraction according to urethroscopy videos analysis
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinique Pasteur
🇫🇷Toulouse, France