Ejaculation Preservation After Laser Enucleation Prostate (EPALEP)

A Multicentre Randomised Controlled Trial Evaluating the Benefit of Median Lobe Preservation on the Incidence of Retrograde Ejaculation During Prostate Enucleation by HoLEP.

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

Study Overview

• Status: Terminated
• Conditions: Prostate Hyperplasia
• Intervention / Treatment: Procedure: HoLEP classic; Procedure: HoLEP with median lobe preservation

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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69009
    • Clinique de la Sauvegarde

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HoLEP classic; Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).	Procedure: HoLEP classic; Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
Experimental: HoLEP with median lobe preservation; Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum.	Procedure: HoLEP with median lobe preservation; Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrograde ejaculation	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)	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Prostate Symtom Score (IPSS) assessment	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	Month 1
International Prostate Symtom Score (IPSS) assessment	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	Month 3
International Prostate Symtom Score (IPSS) assessment	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	Month 6
International Prostate Symtom Score (IPSS) assessment	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	Month 12
Men Sexual Health Questionnaire (MSHQ) score assessment	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)	Month 3
Men Sexual Health Questionnaire (MSHQ) score assessment	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)	Month 6
Men Sexual Health Questionnaire (MSHQ) score assessment	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)	Month 12
International Index of Erectil Function (IIEF-5) score assessment	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.	Month 3
International Index of Erectil Function (IIEF-5) score assessment	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.	Month 6
International Index of Erectil Function (IIEF-5) score assessment	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.	Month 12
Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 1
Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 3
Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 6
Urine flow (Qmax) measurement	Assessment of urine flow (Qmax) by ultrasound	Month 12
Adverse events related to the procedure	Presence of urinary incontinence and occurrence of adverse events related to the procedure	Month 12
Assessment of resected volume / total volume	Assessment of resected volume / total volume assessed by ultrasound	Month 12

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Investigators: Principal Investigator: Arnaud BALDINI, MD PD, Clinique de la Sauvegarde

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 2021-A00031-40

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No