Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology (MOSES)

March 23, 2023 updated by: University Hospital, Bordeaux

To Compare the Effectiveness of the MOSES 2.0 Technology to the Non-MOSES Technology on the Success Rate of Holmium LASER Enucleation of the Prostate (HoLEP) Performed on an Outpatient Basis in the Context of Benign Prostatic Hypertrophy.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

HoLEP is in the process of becoming the new reference surgical treatment for BPH with the main advantages over monopolar transurethral resection (TURPm) and high approach adenomectomy (AVH): the significant reduction in morbidity perioperative period and therefore the reduction in the length of hospital stay. This reduction in length of stay has led to the development of outpatient care with encouraging results. The main cause of discharge failure on D0 is the persistence of postoperative hematuria requiring maintenance of bladder irrigation. MOSESTM 2.0 technology has the advantage of better hemostasis compared to the LASER LP100 currently used. The objective of this study is to evaluate the influence of MOSESTM 2.0 technology on the outpatient success rate in patients operated on for HoLEP for BPH.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology
HoLEP patients with MOSESTM 2.0 effect (open label)
prospective open label
Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patient who discharge on D0 (same day of his surgery)
Time Frame: baseline
baseline
Number of hour's hospitalization
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Intraoperative transfusion rate
Time Frame: baseline
baseline
Duration of post-operative sounding (hours)
Time Frame: baseline
baseline
Readmission rate within 48 hours of discharge from hospital
Time Frame: baseline
baseline
Mean change in IPSS before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in QoL before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in IIEF-5 before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in ICIQ-short form score before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean change in USP before surgery and 3 months after surgery
Time Frame: 3 months after surgery
3 months after surgery
Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative
Time Frame: 3 months after surgery
3 months after surgery
Number of hour's surgery time
Time Frame: baseline
baseline
Rate of enucleated prostate tissue By time treatment per patient
Time Frame: baseline
baseline
number of minutes use of the LASER during surgery
Time Frame: baseline
baseline
quantity of energy used during the intervention per patient
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Grégoire ROBERT, PU-PH, University Hospital Bordeaux, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2022/48

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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