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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

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World Journal of Urology Aims and scope Submit manuscript

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

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Acknowledgements

The authors acknowledge S. MALECA (clinical research assistant), S. RICARD (clinical research assistant), A. GIMBERT (safety and vigilance unit coordinator, PharmD), and F. SGOIFO (data manager), for their assistance in the conduction of this clinical trial. The authors acknowledge all participating investigators: P. BALLANGER, JM. FERRIERE, G. PASTICIER, JC. BERNHARD. The authors acknowledge S. MALECA (clinical research assistant), S. RICARD (clinical research assistant), A. GIMBERT (safety and vigilance unit coordinator, PharmD), and F. SGOIFO (data manager), for their assistance in the conduction of this clinical trial. The authors acknowledge all participating investigators: P. BALLANGER, JM. FERRIERE, G. PASTICIER, JC. BERNHARD.

Author information

Authors and Affiliations

  1. Department of Urology, CHU de Bordeaux, Bordeaux Pellegrin University Hospital, Université de Bordeaux, Place Amélie Raba Léon, 33000, Bordeaux, France

    Grégoire Robert

  2. Department of Urology, CHU de Limoges, 87042, Limoges, France

    Aurélien Descazeaud

  3. Department of Urology, CHU de Marseille, Marseille, France

    Gilles Karsenty

  4. Department of Urology, CHU de Strasbourg, Strasbourg, France

    Christian Saussine

  5. Department of Urology, CHU d’Angers, Angers, France

    Abdel-Rahmène Azzouzi

  6. Department of Urology, CHU Henri Mondor, APHP, Créteil, France

    Alexandre de la Taille

  7. Department of Urology, Hôpital Saint-Louis, APHP, Paris, France

    François Desgrandchamps

  8. Department of Urology, Clinique Beausoleil, Montpellier, France

    Antoine Faix

  9. Department of Urology, CH du Pays d’Aix, Aix en Provence, France

    Marc Fourmarier

  10. CHU de Bordeaux, Clinical Epidemiology Unit, Pôle de Santé Publique, 33000, Bordeaux, France

    Aurore Georget & Antoine Benard

  11. Department of Urology, Hôpital Cochin, APHP, Paris, France

    Nicolas Barry Delongchamps

Authors
  1. Grégoire Robert
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  2. Aurélien Descazeaud
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  3. Gilles Karsenty
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  4. Christian Saussine
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  5. Abdel-Rahmène Azzouzi
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  6. Alexandre de la Taille
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  7. François Desgrandchamps
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  8. Antoine Faix
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  9. Marc Fourmarier
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  10. Aurore Georget
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  11. Antoine Benard
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  12. Nicolas Barry Delongchamps
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Contributions

G. Robert, N. Barry Delongchamps, A. Descazeaud: protocol development, Data collection, Manuscript writing. A. Benard, A. Georget: protocol development, data management, data analysis. G. Karsenty, C. Saussine, M. Fourmarier, A. Azzouzi, A. Faix, F. Desgrandchamps, A. de la Taille: data collection, manuscript editing.

Corresponding author

Correspondence to Grégoire Robert.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Additional information

The study was founded by an unrestricted grant of the French Ministry of Health (PHRC).

Electronic supplementary material

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Supplementary material 1 (DOCX 287 kb)

Supplementary material 2 (DOC 217 kb)

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Robert, G., Descazeaud, A., Karsenty, G. et al. 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. World J Urol 36, 921–929 (2018). https://doi.org/10.1007/s00345-018-2193-y

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  • DOI: https://doi.org/10.1007/s00345-018-2193-y

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