Status:
COMPLETED
Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial
Lead Sponsor:
San Carlo di Nancy Hospital
Collaborating Sponsors:
Elesta S.R.L.
Conditions:
Prostate Hyperplasia
Benign Prostatic Hyperplasia
Eligibility:
MALE
18-75 years
Phase:
NA
Brief Summary
The primary objective of the study is to compare Trans-Perineal Laser Ablation of Prostate versus Trans-Urethral Resection of Prostate in the immediate impact on post-operative pain; in terms of relie...
Detailed Description
Consecutive patients coming to our institution affected by benign prostatic obstruction (BPO) with indication to surgery and strong need of ejaculatory preservation will be enrolled in the present ran...
Eligibility Criteria
Inclusion
- signed written informed consent
- patient able to complete the Whole protocol
- IPSS score ≥ 10
- Maximum urinary flow rate \< 15 ml/sec
- Prostate volume at preop. ultrasonography \< 100 mL
- normal urinalysis (all of the above)
Exclusion
- former prostate surgery
- prostate cancer (history)
- urethral stricture (history)
- Marion's disease (history)
- bladder stones
- median obstructive lobe, as defined by a \> 1 cm of prostate abutting in the bladder lumen at ultrasonography
- neurological conditions potentially impacting on the bladder voiding (at least one of the above)
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04781049
Start Date
January 1 2021
End Date
October 6 2022
Last Update
February 21 2023
Active Locations (1)
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1
San Carlo di Nancy Hospital
Roma, RM, Italy, 00175