Ejaculation Preservation After Laser Enucleation Prostate (EPALEP)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Terminated

Conditions: Prostate Hyperplasia

Treatments: Procedure: HoLEP classic; Procedure: HoLEP with median lobe preservation

Study type: Interventional

Funder types: Other

Identifiers

NCT05017285

2021-A00031-40

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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11 participants in 2 patient groups

HoLEP classic

Other group

Description:

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

Treatment:

Procedure: HoLEP classic

HoLEP with median lobe preservation

Experimental group

Description:

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

Treatment:

Procedure: HoLEP with median lobe preservation