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Comparison of the effectiveness of repeated injections of onabotulinum toxin A for refractory idiopathic detrusor overactivity: analysis of an open label extension of a randomized trial (the RELAX study)

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posted on 31.10.2016, 16:06 by Rhiannon K. Owen, Keith R. Abrams, Christopher Mayne, Mark Slack, Douglas G. Tincello
AIMS: To assess effects of repeat treatment with onabotulinumtoxin A (onaBoNT-A) in women with refractory idiopathic detrusor overactivity (DO). METHODS: Analysis of an open-label extension study of a large randomized placebo controlled trial of onaBoNT-A. Participants had been randomized to receive 200 IU onaBoNTA or placebo and were offered up to two further onaBoNTA injections over a 5-year period. For this analysis, the primary outcome was duration of treatment effect by patient-reported symptom return. Weibull proportional hazards regression models were fitted in a Bayesian framework to estimate missing times. Multivariable hazard regression analysis (hazard ratio, 95% credible intervals (HR, 95% CrI) compared repeated injections adjusting for differences in baseline symptom severity. Secondary outcomes included inter-injection interval, incontinence, urgency, and voiding episodes 6 weeks after injection. RESULTS: Four hundred and forty-two active injections were administered: 228 patients had one, 155 had two, and 59 had three injections. Time to symptom return for injection number 1 and 2 was 84 (95%CI: 63, 112) and 180 (95%CI: 135, 223) days, respectively. Median inter-injection intervals for receiving second and third injection were 266 days (range: 130, 1400) and 372 days (range: 134, 1283). No statistically significant differences in symptom outcomes or time to symptom return (HR 0.88, 95% CrI 0.37, 2.07 for injection 2, HR 0.33, 95% CrI 0.09, 1.03 for injection 3) were observed. CONCLUSIONS: Repeated onaBoNT-A injections have consistent efficacy and duration of action. There appears to be long-term placebo effects in both groups of randomized patients, with implications for open-label extension studies.

History

Citation

Neurourol Urodyn, 2017, 36 (4), pp. 1201-1207

Author affiliation

/Organisation/COLLEGE OF MEDICINE, BIOLOGICAL SCIENCES AND PSYCHOLOGY/School of Medicine/Department of Health Sciences

Version

AM (Accepted Manuscript)

Published in

Neurourol Urodyn

Publisher

Wiley

issn

0733-2467

eissn

1520-6777

Acceptance date

21/07/2016

Copyright date

2016

Available date

26/08/2017

Publisher version

http://onlinelibrary.wiley.com/doi/10.1002/nau.23095/abstract

Notes

The file associated with this record is under a 12 month embargo from publication in accordance with the publisher's self-archiving policy. The full text may be available through the publisher links provided above.

Language

en