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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Benign Prostatic Hypertrophy, Holmium Laser Enucleation of the Prostate

Intervention / Treatment
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* Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)
* Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HoLEP patients without MOSESTM 2.0 effect (open label)<br>control retrospective open label | Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)<br>* HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology<br>|
| HoLEP patients with MOSESTM 2.0 effect (open label)<br>prospective open label | Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)<br>* HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient who discharge on D0 (same day of his surgery) |  | baseline | 
| Number of hour's hospitalization |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of hour's surgery time |  | baseline | 
| Rate of enucleated prostate tissue By time treatment per patient |  | baseline | 
| number of minutes use of the LASER during surgery |  | baseline | 
| quantity of energy used during the intervention per patient |  | baseline | 
| Intraoperative transfusion rate |  | baseline | 
| Duration of post-operative sounding (hours) |  | baseline | 
| Readmission rate within 48 hours of discharge from hospital |  | baseline | 
| Mean change in IPSS before surgery and 3 months after surgery |  | 3 months after surgery | 
| Mean change in QoL before surgery and 3 months after surgery |  | 3 months after surgery | 
| 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 | 
| Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative |  | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Men, Benign Prostatic Hypertrophy, HoLEP, MOSES(TM) 2.0, Ambulatory