Ejaculation Preservation After Laser Enucleation Prostate

Not Applicable

Terminated

• Conditions: Prostate Hyperplasia
• Interventions: Procedure: HoLEP with median lobe preservation; Procedure: HoLEP classic

• Registration Number: NCT05017285
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-23
• Study Start: 2022-01-14
• Primary Completion: 2022-09-30
• Study Completion: 2023-03-31
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HoLEP with median lobe preservation	HoLEP with median lobe preservation	Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum.
HoLEP classic	HoLEP classic	Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).

Primary Outcome Measures

Name	Time	Method
Retrograde ejaculation	Month 6	Existence of retrograde ejaculation at Month 6, as evidenced by the presence of spermatozoa in the urine following sexual intercourse (as evidenced by an ECBU performed within 24 hours of intercourse)

Secondary Outcome Measures

Name	Time	Method
Urine flow (Qmax) measurement	Month 12	Assessment of urine flow (Qmax) by ultrasound
Assessment of resected volume / total volume	Month 12	Assessment of resected volume / total volume assessed by ultrasound
International Prostate Symtom Score (IPSS) assessment	Month 12	The International Prostate Symtom Score (IPSS) is a structured and validated self-administered questionnaire that assesses the intensity and discomfort of lower urinary tract disorders. It consists of 7 questions on symptomatology with answers rated from 0 to 5 and one question on quality of life. A score of \<7 is mild, a score of 8-19 is moderate and a score of \>20 is severe
Men Sexual Health Questionnaire (MSHQ) score assessment	Month 12	The Men Sexual Health Questionnaire (MSHQ) assesses a patient's ability to have sex. It consists of 25 questions that explore the ability to have erections, the quality of ejaculations and the satisfaction felt during intercourse and sexual desire.; The total score (16 to 125 points maximum) is broken down into 6 sub-scores that explore erection (0 to 15 points), discomfort with erection problems (1 to 5 points), ejaculation (1 to 35 points), discomfort with ejaculation problems (1 to 5 points), satisfaction (6 to 30 points), sexual activity and desire (7 to 35 points)
Adverse events related to the procedure	Month 12	Presence of urinary incontinence and occurrence of adverse events related to the procedure
International Index of Erectil Function (IIEF-5) score assessment	Month 12	The IIEF-5 (International Index of Erectile Function) questionnaire consists of 5 questions that assess erectile function over the past 6 months. Severe erectile dysfunction corresponds to a score of 5-10, moderate erectile dysfunction to a score of 11-15 and mild erectile dysfunction to a score of 16-20. A score of 21 to 25 corresponds to normal erectile function and scores between 1 and 4 are not interpretable.

Trial Locations

Locations (1)

Clinique de la Sauvegarde; 🇫🇷 Lyon, France