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

University Hospital of Bordeaux

Status

Active, not recruiting

Conditions

Benign Prostatic Hypertrophy

Holmium Laser Enucleation of the Prostate

Treatments

Procedure: HoLEP patients with MOSES(TM) 2.0 effect (open label)

Procedure: HoLEP patients without MOSES(TM) 2.0 effect (open label)

Study type

Observational

Funder types

Other

Identifiers

NCT05768776

CHUBX2022/48

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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