Clinical trial NCT05768776: Outpatient Holmium LASER Enucleation of the Prostate: Benefit of MOSES(TM) 2.0 Technology
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostatic Hypertrophy
Holmium Laser Enucleation of the Prostate
Keywords: Benign Prostatic Hypertrophy
HoLEP
MOSES(TM) 2.0
Ambulatory
Men
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 200
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients who require HoLEP for Begnign Prostate Hypertrophy eligible for outpatient management
* Patients having been managed by HoLEP (without MOSES 2.0) in ambulatory care since January 2016 in the urology department of the Bordeaux University Hospital.

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.

Eligibility 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

Primary outcomes:
measure: Number of patient who discharge on D0 (same day of his surgery)
timeFrame: baseline
measure: Number of hour's hospitalization
timeFrame: baseline
Secondary outcomes:
measure: Number of hour's surgery time
timeFrame: baseline
measure: Rate of enucleated prostate tissue By time treatment per patient
timeFrame: baseline
measure: number of minutes use of the LASER during surgery
timeFrame: baseline
measure: quantity of energy used during the intervention per patient
timeFrame: baseline
measure: Intraoperative transfusion rate
timeFrame: baseline
measure: Duration of post-operative sounding (hours)
timeFrame: baseline
measure: Readmission rate within 48 hours of discharge from hospital
timeFrame: baseline
measure: Mean change in IPSS before surgery and 3 months after surgery
timeFrame: 3 months after surgery
measure: Mean change in QoL before surgery and 3 months after surgery
timeFrame: 3 months after surgery
measure: Mean change in IIEF-5 before surgery and 3 months after surgery
timeFrame: 3 months after surgery
measure: Mean change in ICIQ-short form score before surgery and 3 months after surgery
timeFrame: 3 months after surgery
measure: Mean change in USP before surgery and 3 months after surgery
timeFrame: 3 months after surgery
measure: Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital Bordeaux, France
name: Grégoire ROBERT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: