NCT04781049

Transperineal Laser Ablation vs Transurethral Resection for Benign Prostatic Obstruction: A Randomized Clinical Trial

Completed NA Last updated 21 February 2023

What this trial tests

NA trial testing Trans-Perineal Laser Ablation of Prostate in Prostate Hyperplasia in 51 participants. Completed in 6 October 2022.

Timeline

1 January 2021

Primary endpoint
20 September 2021

6 October 2022

Quick facts

Lead sponsor	San Carlo di Nancy Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	1 January 2021
Primary completion	20 September 2021
Estimated completion	6 October 2022
Sites	1 location across Italy

Drugs / interventions tested

• Trans-Perineal Laser Ablation of Prostate
• Trans-Urethral Resection of Prostate

Conditions studied

• Prostate Hyperplasia — all drugs for Prostate Hyperplasia →
• Benign Prostatic Hyperplasia — all drugs for Benign Prostatic Hyperplasia →
• Benign Prostatic Hypertrophy — all drugs for Benign Prostatic Hypertrophy →
• Benign Prostatic Hypertrophy With Outflow Obstruction — all drugs for Benign Prostatic Hypertrophy With Outflow Obstruction →

Sponsor

San Carlo di Nancy Hospital

Who can join

Adults 18 to 75, male only, with Prostate Hyperplasia or Benign Prostatic Hyperplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 relief in benign prostatic obstruction and preservation of the ejaculatory function in the short term (at 1, 3 and 6 months).

The secondary objective of the study is the evaluation of the long-term deobstructive effectiveness (12 months).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Ejaculatory function following transperineal laser ablation vs TURP for benign prostatic obstruction: a randomized trial.
   Bertolo R, Iacovelli V, Cipriani C, Carilli M, et al · · 2023 · cited 23× · PMID 36917033 · DOI 10.1111/bju.16008