NCT05017285

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

August 16, 2021

Last Update Submit

July 2, 2024

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • International Prostate Symtom Score (IPSS) assessment

    Month 1

  • International Prostate Symtom Score (IPSS) assessment

    Month 3

  • International Prostate Symtom Score (IPSS) assessment

    Month 6

  • International Prostate Symtom Score (IPSS) assessment

    Month 12

  • Men Sexual Health Questionnaire (MSHQ) score assessment

    Month 3

  • +11 more secondary outcomes

Study Arms (2)

HoLEP classic

OTHER

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

Procedure: HoLEP classic

HoLEP with median lobe preservation

EXPERIMENTAL

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

Procedure: HoLEP with median lobe preservation

Interventions

HoLEP with median lobe preservationPROCEDURE

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

HoLEP with median lobe preservation
HoLEP classicPROCEDURE

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

HoLEP classic

Eligibility Criteria

Age40 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsStudy on prostate hyperplasia
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de la Sauvegarde

Lyon, 69009, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Arnaud BALDINI, MD PD

    Clinique de la Sauvegarde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patient does not know which type of surgery is used
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 23, 2021

Study Start

January 14, 2022

Primary Completion

September 30, 2022

Study Completion

March 31, 2023

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)