Ejaculation Preservation After Laser Enucleation Prostate

NCT ID: NCT05017285

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-14
• Study Completion Date: 2023-03-31

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.

Conditions

Prostate Hyperplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

HoLEP classic

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

Group Type: OTHER

HoLEP classic

Intervention Type: PROCEDURE

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

HoLEP with median lobe preservation

Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum.

Group Type: EXPERIMENTAL

HoLEP with median lobe preservation

Intervention Type: PROCEDURE

Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum

Interventions

HoLEP with median lobe preservation

Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum

Intervention Type: PROCEDURE

HoLEP classic

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud BALDINI, MD PD

Role: PRINCIPAL_INVESTIGATOR

Clinique de la Sauvegarde

Locations

Clinique de la Sauvegarde

Lyon, , France

Countries

France

Other Identifiers

2021-A00031-40

Identifier Type: -

Identifier Source: org_study_id