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An exploratory, placebo-controlled, dose–response study of the efficacy and safety of onabotulinumtoxinA in spinal cord injury patients with urinary incontinence due to neurogenic detrusor overactivity

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World Journal of Urology Aims and scope Submit manuscript

Abstract

Purpose

To explore the dose response to onabotulinumtoxinA 50, 100, and 200 U in patients with spinal cord injury (SCI) with urinary incontinence (UI) due to neurogenic detrusor overactivity (NDO).

Methods

Patients (N = 73) with SCI (level T1 or lower) with NDO and UI (≥14 UI episodes/week) received 30 intradetrusor injections of onabotulinumtoxinA (50 U [n = 19], 100 U [n = 21], or 200 U [n = 17]) or placebo (n = 16) via cystoscopy, avoiding the trigone. Changes from baseline in UI episodes/week, volume voided/micturition, maximum cystometric capacity, and maximum detrusor pressure (MDP) during first involuntary detrusor contraction (IDC) were evaluated. Adverse events (AEs) were assessed.

Results

A significant linear dose response for UI episodes/week was identified at weeks 18, 30, 36, 42, and 54 (P < 0.05) with a similar trend (P = 0.092) at week 6 (primary time point). A significant linear dose response was observed in volume/void at all post-treatment time points up to week 54 (P < 0.05) and in MDP during first IDC at week 6 (P = 0.034). The proportion of patients who achieved continence at week 6 was highest in the 200 U group. Duration of effect was longest with the 200 U dose, compared with other treatment groups. The AEs were comparable across groups; urinary tract infection was the most common AE across all treatment groups.

Conclusions

In this exploratory dose–response study of SCI patients with UI due to NDO, onabotulinumtoxinA 200 U was the most effective dose. The AE profile was comparable across all groups.

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Notes

  1. Units of biological activity of onabotulinumtoxinA cannot be compared to or converted into units of any other botulinum toxin product, and onabotulinumtoxinA is not interchangeable with other botulinum toxin preparations.

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Acknowledgments

The authors acknowledge the contributions of principal investigators in each country. Serbia: M. Lazic, A. Milosevic, and C. Tulic; Greece: A. Apostolidis, A. Athanasopoulos, and F. Sofras; Turkey: F. Demirel, C. Ozyurt, B. Seckin, and T. Tarcan; Egypt: I. Hafeez and S. Mourad; India: G. Mathew, P. Murthy, H. Nagaraj, H. Pathak, R. Shimpi, S. Shroff, K. Shukla, and S. Sinha. Writing assistance for manuscript development was provided by Jaya Kolipaka of Evidence Scientific Solutions and funded by Allergan, Inc. Apostolos Apostolidis is an investigator for Allergan, Inc., Astellas Pharma, Inc., Pfizer Inc, Pharmaserve-Lilly, and GlaxoSmithKline. He is a consultant for Allergan, Inc. and Astellas Pharma, Inc., and has received lecturer honoraria from Allergan, Inc., Astellas Pharma, Inc., and Pfizer Inc, and investigator-initiated research grants from Astellas Pharma, Inc. and Pfizer Inc. Sherif Mourad is on the consultant board for Pfizer AfME Group and has received lecturer honoraria from Pfizer Inc and investigator-initiated research grants from Allergan, Inc. and Pfizer Inc. Catherine Thompson and Xiaohong Yan are employees of Allergan, Inc.

Conflict of interest

This study was funded by Allergan, Inc.

Author information

Authors and Affiliations

  1. 2nd Department of Urology, Papageorgiou General Hospital, Aristotle University of Thessaloniki, 56403, Thessaloníki, Greece

    Apostolos Apostolidis

  2. Allergan, Ltd., Marlow, Buckinghamshire, UK

    Catherine Thompson

  3. Allergan Inc., Irvine, CA, USA

    Xiaohong Yan

  4. Ain Shams University, Cairo, Egypt

    Sherif Mourad

Authors
  1. Apostolos Apostolidis
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  2. Catherine Thompson
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  3. Xiaohong Yan
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  4. Sherif Mourad
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Corresponding author

Correspondence to Apostolos Apostolidis.

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Apostolidis, A., Thompson, C., Yan, X. et al. An exploratory, placebo-controlled, dose–response study of the efficacy and safety of onabotulinumtoxinA in spinal cord injury patients with urinary incontinence due to neurogenic detrusor overactivity. World J Urol 31, 1469–1474 (2013). https://doi.org/10.1007/s00345-012-0984-0

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  • DOI: https://doi.org/10.1007/s00345-012-0984-0

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