Prostatic Injection of Botulinum Toxin is Not Inferior to Optimized Medical Therapy in the Management of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Results of a Randomized Clinical Trial

Overview

Journal World J Urol

Specialty Urology

Date 2018 Feb 1

PMID 29383480

Citations 2

Authors

Gregoire Robert

Aurelien Descazeaud

Gilles Karsenty

Christian Saussine

Abdel-Rahmene Azzouzi

Alexandre De La Taille

Francois Desgrandchamps

Antoine Faix

Marc Fourmarier

Aurore Georget

Antoine Benard

Nicolas Barry Delongchamps

Affiliations

Soon will be listed here.

Abstract

Objective: To explore efficacy and safety of Botulinum Neurotoxin Type A (BoNT-A) prostatic injection in patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperperplasia.

Materials And Methods: A phase 3 multicenter open-labeled study randomised patients to receive BoNT-A prostatic injection or optimized medical therapy. BoNT-A injection consisted in trans-rectal injections of 200 UI in the transitional zone of the prostate. Optimal medical therapy consisted in oral medication with any drug patented for LUTS. One month (M1) after randomisation patients in the BoNT-A group were asked to stop any medical therapy related to LUTS. The main judgment criterion was the IPSS score at M4. Per-protocol analysis was performed with a non-inferiority hypothesis (ΔIPSS < 3).

Results: 127 patients were randomised to BoNT-A (n = 64) or medical therapy (n = 63). At randomisation mean IPSS was 16.9 ± 7.2 in the BoNT-A group vs 15.7 ± 7.3 in control. In the BoNT-A group, 44 patients (73.3%) could interrupt medical therapy for LUTS from M1 to M4. At M4, mean IPSS score was 12.0 ± 6.7 in the BoNT-A group vs 11.8 ± 6.9 in control. After adjustment for baseline IPSS, delta IPSS between groups was 0.01; 95% CI [- 2.14; 2.11] leading to accept the non-inferiority hypothesis.

Conclusions: Four months after BoNT-A injection, most of the patients could interrupt LUTS-related medical treatments. In these patients, IPSS improvement was not inferior to optimized medical treatment, but the study design did not allow to conclude that this improvement was related with study drug rather than with sustained placebo effect.

Trial Registration: NCT01275521.

Citing Articles

[Botulinum toxin in male lower urinary tract symptoms (LUTS): What can we expect?].

Schonburg S Urologie. 2024; 63(7):653-657.

PMID: 38698262 DOI: 10.1007/s00120-024-02352-0.

Effects of Tamsulosin Combined With Solifenacin on Lower Urinary Tract Symptoms: Evidence From a Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomized Controlled Trials.

Song Y, Chen G, Huang P, Hu C, Liu X Front Pharmacol. 2020; 11:763.

PMID: 32528291 PMC: 7264120. DOI: 10.3389/fphar.2020.00763.

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