Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology (NCT05768776) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology
France200 participantsStarted 2023-06-28
Plain-language 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.
Who can participate
Age range50 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Number of patient who discharge on D0 (same day of his surgery)