Clinical trial NCT05017285: Ejaculation Preservation After Laser Enucleation Prostate
Official title: A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Hyperplasia
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 11
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomised multicentre single-blind comparative study of two parallel groups of patients scheduled for HoLEP prostate resection:

Group 1 Conventional HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).

Group 2 Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum Each patient will be evaluated five times during the study (D0, M1, M3, M6, M12) The total duration of the study is 2 years (1 year of recruitment and 1 year of follow-up).
Primary purpose: TREATMENT

Brief summary: A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.

Detailed description: The main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing Holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.

Eligibility criteria: Inclusion Criteria:

* Patients aged 40 years and older who have signed their consent to participate in the study
* Patient with preserved cognitive functions
* Patient with BPH characterised by an IPSS score ≥ 12, a Qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc
* Patient for whom an indication for prostatic resection by HoLEP has been made,
* A patient who is sexually active and willing to maintain sexual activity after surgery
* Patient affiliated to a social security system or beneficiary of such a system

Exclusion Criteria:

* History of prostate surgery or prostate radiotherapy
* Urethral stenosis
* Cancer or a history of cancer
* Patient with a life expectancy of less than 2 years
* Patient refusing partial surgery
* History of vasectomy, erectile dysfunction or ejaculation
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient under court protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months

Primary outcomes:
measure: Retrograde ejaculation
timeFrame: Month 6
Secondary outcomes:
measure: International Prostate Symtom Score (IPSS) assessment
timeFrame: Month 1
measure: International Prostate Symtom Score (IPSS) assessment
timeFrame: Month 3
measure: International Prostate Symtom Score (IPSS) assessment
timeFrame: Month 6
measure: International Prostate Symtom Score (IPSS) assessment
timeFrame: Month 12
measure: Men Sexual Health Questionnaire (MSHQ) score assessment
timeFrame: Month 3
measure: Men Sexual Health Questionnaire (MSHQ) score assessment
timeFrame: Month 6
measure: Men Sexual Health Questionnaire (MSHQ) score assessment
timeFrame: Month 12
measure: International Index of Erectil Function (IIEF-5) score assessment
timeFrame: Month 3
measure: International Index of Erectil Function (IIEF-5) score assessment
timeFrame: Month 6
measure: International Index of Erectil Function (IIEF-5) score assessment
timeFrame: Month 12
measure: Urine flow (Qmax) measurement
timeFrame: Month 1
measure: Urine flow (Qmax) measurement
timeFrame: Month 3
measure: Urine flow (Qmax) measurement
timeFrame: Month 6
measure: Urine flow (Qmax) measurement
timeFrame: Month 12
measure: Adverse events related to the procedure
timeFrame: Month 12
measure: Assessment of resected volume / total volume
timeFrame: Month 12
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
affiliation: Clinique de la Sauvegarde
name: Arnaud BALDINI, MD PD
role: PRINCIPAL_INVESTIGATOR
References: