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

Last updated: June 24, 2025
Sponsor: University Hospital, Bordeaux
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Benign Prostatic Hyperplasia (Enlarged Prostate)

Prostate Disorders

Treatment

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

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

Clinical Study ID

NCT05768776
CHUBX2022/48
  • Ages > 50
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Inability to read or write French

  • Patients with comorbidities contraindicating general anesthesia

  • Patients not eligible for outpatient care according to French recommendations (highrisk of complications after general anesthesia, place of residence more than 150 kmfrom 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 theirconsent

  • Patients deprived of liberty by a judicial or administrative decision orhospitalized without consent or admitted to a health or social establishment forpurposes other than research

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: HoLEP patients without MOSES(TM) 2.0 effect (open label)
Phase:
Study Start date:
June 28, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • CHU de Bordeaux

    Bordeaux, 33075
    France

    Site Not Available

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