Clinical trial · Observational
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.
NCT05768776CI-TRIAL-00091341MOSESactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Prostatic Hypertrophy | Benign Prostatic Hyperplasia | ALIAS | 0.90 |
| Holmium Laser Enucleation of the Prostate | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HoLEP patients with MOSES(TM) 2.0 effect (open label) | Procedure | — | UNRESOLVED |
| HoLEP patients without MOSES(TM) 2.0 effect (open label) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- HoLEP patients without MOSESTM 2.0 effect (open label)
- description
- control retrospective open label
- interventionNames
- Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)
- label
- HoLEP patients with MOSESTM 2.0 effect (open label)
- description
- prospective open label
- interventionNames
- Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)
Primary outcomes (2)
- measure
- Number of patient who discharge on D0 (same day of his surgery)
- timeFrame
- baseline
- measure
- Number of hour's hospitalization
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.