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

Benign Prostatic Hypertrophy Clinical Trial

— MOSES  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05768776
• Other study ID #: CHUBX2022/48
• Status: Not yet recruiting
• Start date: April 2023
• Est. completion date: August 2024

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: Grégoire 1 ROBERT, PU-PH
• Phone: 33-5-57-82-12-15
• Email: gregoire.robert[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy
• Hypertrophy
• Prostatic Hyperplasia

Intervention

Procedure:
• HoLEP patients without MOSES(TM) 2.0 effect (open label)
HoLEP surgery for the treatment of Benign Prostate Hyperthrophy, without using MOSES technology
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient who discharge on D0 (same day of his surgery)		baseline
Primary	Number of hour's hospitalization		baseline
Secondary	Number of hour's surgery time		baseline
Secondary	Rate of enucleated prostate tissue By time treatment per patient		baseline
Secondary	number of minutes use of the LASER during surgery		baseline
Secondary	quantity of energy used during the intervention per patient		baseline
Secondary	Intraoperative transfusion rate		baseline
Secondary	Duration of post-operative sounding (hours)		baseline
Secondary	Readmission rate within 48 hours of discharge from hospital		baseline
Secondary	Mean change in IPSS before surgery and 3 months after surgery		3 months after surgery
Secondary	Mean change in QoL before surgery and 3 months after surgery		3 months after surgery
Secondary	Mean change in IIEF-5 before surgery and 3 months after surgery		3 months after surgery
Secondary	Mean change in ICIQ-short form score before surgery and 3 months after surgery		3 months after surgery
Secondary	Mean change in USP before surgery and 3 months after surgery		3 months after surgery
Secondary	Mean evolution of Qmax and post-void residual (RPM) before the intervention and at 3 months post-operative		3 months after surgery