Outpatient treatment for enlarged prostate using advanced laser 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.
This study is testing whether using a new laser technology during outpatient surgery for an enlarged prostate can improve recovery and success rates for men with this condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05768776 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the success rates of outpatient surgery for benign prostatic hypertrophy (BPH) using holmium laser enucleation of the prostate (HoLEP) with and without the MOSES 2.0 technology. HoLEP is emerging as a preferred surgical option due to its reduced morbidity and shorter hospital stays compared to traditional methods. The study will evaluate how the MOSES 2.0 technology, which offers improved hemostasis, affects the success of outpatient procedures. Participants will be monitored for postoperative outcomes to determine the effectiveness of the technology in enhancing patient recovery.
Who should consider this trial
Good fit: Ideal candidates are men over 50 years old with symptomatic BPH requiring surgical intervention.
Not a fit: Patients with a history of prostate cancer or those not eligible for outpatient care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outpatient surgical outcomes for men suffering from BPH.
How similar studies have performed: Previous studies have shown promising results with HoLEP techniques, but the specific application of MOSES 2.0 technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Grégoire ROBERT, PU-PH — University Hospital Bordeaux, France
- Study coordinator: Grégoire 1 ROBERT, PU-PH
- Email: gregoire.robert@chu-bordeaux.fr
- Phone: 33-5-57-82-12-15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.