NCT05768776

Brief Summary

The aim of this study is to compare the success rate of outpatient surgery after holmium LASER enucleation of the prostate (HoLEP) for the treatment of BPH with and without the use of the MOSES 2.0 effect.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

March 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

March 3, 2023

Last Update Submit

June 24, 2025

Conditions

Benign Prostatic HypertrophyHolmium Laser Enucleation of the Prostate

Keywords

Benign Prostatic HypertrophyHoLEPMOSES(TM) 2.0AmbulatoryMen

Outcome Measures

Primary Outcomes (2)

  • Number of patient who discharge on D0 (same day of his surgery)

    baseline

  • Number of hour's hospitalization

    baseline

Secondary Outcomes (13)

  • Number of hour's surgery time

    baseline

  • Rate of enucleated prostate tissue By time treatment per patient

    baseline

  • number of minutes use of the LASER during surgery

    baseline

  • quantity of energy used during the intervention per patient

    baseline

  • Intraoperative transfusion rate

    baseline

  • +8 more secondary outcomes

Study Arms (2)

HoLEP patients without MOSESTM 2.0 effect (open label)

control retrospective open label

Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)

HoLEP patients with MOSESTM 2.0 effect (open label)

prospective open label

Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)

Interventions

HoLEP patients without MOSES(TM) 2.0 effect (open label)PROCEDURE

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology

HoLEP patients without MOSESTM 2.0 effect (open label)
HoLEP patients with MOSES(TM) 2.0 effect (open label)PROCEDURE

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

HoLEP patients with MOSESTM 2.0 effect (open label)

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients who require HoLEP for Begnign Prostate Hypertrophy eligible for outpatient management * Patients having been managed by HoLEP (without MOSES 2.0) in ambulatory care since January 2016 in the urology department of the Bordeaux University Hospital.

You may qualify if:

  • Subject over 50 years old
  • BPH whose symptoms require surgical management
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) ≥ 40g
  • IPSS score \> 15 and Quality of Life score ≥ 3
  • Maximum urinary output (Qmax) \< 15 ml/sec

You may not qualify if:

  • Inability to read or write French
  • Patients with comorbidities contraindicating general anesthesia
  • Patients not eligible for outpatient care according to French recommendations (high risk of complications after general anesthesia, place of residence more than 150 km from an emergency department, alone at home the night following the intervention) .
  • History of BPH surgery
  • History of prostate cancer
  • Preoperative prostate volume measured by ultrasound (suprapubic or transrectal) \< 40g
  • Existence or history of urethral stricture
  • Existence or suspicion of a "neurological" bladder
  • Positive preoperative cytobacteriological examination not treated appropriately
  • Adult patients subject to a legal protection measure or unable to express their consent
  • Patients deprived of liberty by a judicial or administrative decision or hospitalized without consent or admitted to a health or social establishment for purposes other than research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33075, France

Location

MeSH Terms

Conditions

Prostatic HyperplasiaMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Grégoire ROBERT, PU-PH

    University Hospital Bordeaux, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2023

First Posted

March 14, 2023

Study Start

June 28, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)