Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology
- Conditions
- Holmium Laser Enucleation of the ProstateBenign Prostatic Hypertrophy
- Registration Number
- NCT05768776
- Lead Sponsor
- University Hospital, Bordeaux
- Brief 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of hour's hospitalization baseline Number of patient who discharge on D0 (same day of his surgery) baseline
- Secondary Outcome Measures
Name Time Method Number of hour's surgery time baseline Mean change in QoL before surgery and 3 months after surgery 3 months after surgery Rate of enucleated prostate tissue By time treatment per patient baseline Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative 3 months after surgery Intraoperative transfusion rate baseline Mean change in IPSS before surgery and 3 months after surgery 3 months after surgery Readmission rate within 48 hours of discharge from hospital baseline number of minutes use of the LASER during surgery baseline quantity of energy used during the intervention per patient baseline Duration of post-operative sounding (hours) baseline Mean change in IIEF-5 before surgery and 3 months after surgery 3 months after surgery Mean change in ICIQ-short form score before surgery and 3 months after surgery 3 months after surgery Mean change in USP before surgery and 3 months after surgery 3 months after surgery
Trial Locations
- Locations (1)
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU de Bordeaux🇫🇷Bordeaux, France