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Active Not RecruitingNCT05768776

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

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.

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
Male
Age
50 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREHoLEP patients without MOSES(TM) 2.0 effect (open label)HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology
PROCEDUREHoLEP patients with MOSES(TM) 2.0 effect (open label)HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

Timeline

Start date
2023-06-28
Primary completion
2025-07-01
Completion
2025-07-01
First posted
2023-03-14
Last updated
2025-06-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05768776. Inclusion in this directory is not an endorsement.