BERKELEY, CA (UroToday.com) - Botulinum toxin A injections into the bladder for overactive bladder (OAB) has been in use for over a decade. Although botulinum toxin-A was approved for OAB by the National Institute of Clinical Excellence (NICE) in 2006, it was licensed only in 2013 both in the UK and the USA. The preparation approved for use is onabotulinum toxin-A (Botox®) as most of the studies[1, 2, 3, 4] were conducted with this preparation.
In this paper, we describe the clinical outcome and the efficacy in women who had been successfully treated with at least 3 or more doses of abobotulinum toxin-A (Dysport®) injected into the bladder. This study also evaluated the duration of therapy of those who successfully responded to this treatment by using the validated ICIQ-SF and the bladder diary between 2 and 4 months after the injections. Our drugs & therapeutics committee and the clinical effectiveness department introduced intravesical botulinum toxin-A into the hospital in 2004 following approval of its use. We identified 33 women with OAB who were refractory to at least 2 or more anticholinergic therapies, and they received 3 or more injections of abobotulinum toxin-A (Dysport®). All women were advised to undergo training of clean intermittent self-catheterization (CISC) prior to the injection. All women received 500 units of Dysport® and increased to 750 units if required. The criterion for dose escalation was if there was a return of symptoms within 6 months. The botulinum toxin was injected around 20 sites by using the trigone-sparing technique for both flexible and rigid cystoscopies.
Our results show that the comparison of first, second, and third injections before and after injections showed significant improvements. However, there was no significant difference between the responses after all of the 3 injections with respect to ICIQ scores. The mean duration between the first and second injection was 15.2 ±7.2 months, and between the second and the third it was 19.2±10 months, which is statistically significant.
Two (6%) women developed urinary tract infections (UTI) following all of the injections. UTIs were treated with oral antibiotics as outpatients. None of them had to be admitted for severe urosepsis. Therefore they did not require intravenous antibiotic therapy. However, the patients who developed UTI were different on each occasion. Two (6%) patients had to do CISC due to high residual volume > 150 ml following the procedure on the day of the procedure, and also at 2-4 weeks review, however, the patients were different after each episode. They preferred to do the CISC as their urinary symptoms improved significantly.
As far as we are aware, this is the first study evaluating repeated administration of abobotulinum toxin-A (Dysport®) and reporting outcomes in a “real world” situation and a “real life” experience in the UK National Health Service (NHS). This study was the only one that evaluated this therapy in women in comparison to the other studies where it was used in both sexes. Our data reflect the outcomes of 33 successfully treated women in a staggered fashion over a period of 7 years. Therefore it is not expected that all women have had similar responses and similar inter-injection intervals. Nevertheless, the inter-injection interval was significantly prolonged in comparison to the other studies. It may be because the preparation used was Dysport®. Our study also confirms that this is not only safe but also effective.
Although there have been comparative studies between Botox® and Dysport® in other conditions such as hyperhidrosis[5] and facial rhytids,[6] interestingly there have been no randomized studies comparing these two preparations for OAB. We recommend the need for randomized trials between Botox® and Dysport® in view of our findings.
References:
- Duthie, J., Wilson, D.I., Herbison, G.P. and Wilson, D. (2007). Botulinum toxin injections for adults with overactive bladder syndrome. The Cochrane Database of Systematic Reviews: CD005493.
- Dowson, C., Watkins, J., Khan, M.S., Dasgupta, P. and Sahai, A. (2012). Repeated botulinum toxin type A injections for refractory overactive bladder: medium-term outcomes, safety profile, and discontinuation rates. European Urology 61: 834-839.
- Popat, R., Apostolidis, A., Kalsi, V., Gonzales, G., Fowler, C.J. and Dasgupta, P. (2005). A comparison between the response of patients with idiopathic detrusor overactivity and neurogenic detrusor overactivity to the first intradetrusor injection of botulinum-A toxin. Journal of Urology 174: 984-989.
- Sahai, A., Dowson, C., Khan, M.S. and Dasgupta, P. (2009). Improvement in quality of life after botulinum toxin-A injections for idiopathic detrusor overactivity: results from a randomized double-blind placebo-controlled trial. BJU International 103: 1509-1515.
- El Kahky, H.M., Diab, H.M., Aly, D.G. and Farag, N.M. (2013). Efficacy of Onabotulinum Toxin A (Botox) versus Abobotulinum Toxin A (Dysport) Using a Conversion Factor (1 : 2.5) in Treatment of Primary Palmar Hyperhidrosis. Dermatology Research and Practice 2013: 686329.
- Kassir, R., Kolluru, A. and Kassir, M. (2013). Triple-Blind, Prospective, Internally Controlled Comparative Study Between AbobotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Facial Rhytids. Dermatology and Therapy 3: 179-189.
Written by:
Angamuthu Arunkalaivanan as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc... of their research by referencing the published abstract.
Department of Obstetrics and Gynaecology, City Hospital, Dudley Road, Birmingham, United Kingdom
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