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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-28

Study Completion Date

2025-07-31

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.

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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.

Conditions

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Benign Prostatic Hypertrophy Holmium Laser Enucleation of the Prostate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HoLEP patients without MOSESTM 2.0 effect (open label)

control retrospective open label

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

Intervention Type PROCEDURE

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology

HoLEP patients with MOSESTM 2.0 effect (open label)

prospective open label

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

Intervention Type PROCEDURE

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

Interventions

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

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology

Intervention Type PROCEDURE

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

HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, with the use of MOSES technology

Intervention Type PROCEDURE

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

Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No