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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05768776
Other study ID # CHUBX2022/48
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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