The extension study lasting until week 24 suggested that most of these beneficial effects of BTX-A were maintained for at least 24 weeks. At baseline, 81% of patients in the BTX-A group were experiencing urgent urinary incontinence daily, but urinary frequency normalized in 57% at 4 weeks, and 36% maintained this benefit at 24 weeks; further, 50% were continent at follow-up, and the improvement lasted 24 weeks. Complete resolution of detrusor overactivity was observed in 44% of BTX-A patients at 4 weeks, though this dropped to 25% by 24 weeks.
Quality of life was assessed using the IIQ-7 and UDI-6 and was significantly better in the BTX-A group compared with placebo at both 4 and 12 weeks post-injections.
Treatment with BTX-A was well tolerated and there were no major complications. Six patients in the BTX-A group had symptomatic post void residual (PVR) at follow-up requiring clean intermittent self catheterization (CISC). Seven patients developed symptomatic urinary tract infection, six of whom were performing CISC. Mr. Sahai's and Mr. Dasgupta's co-researcher was Mohammad S. Khan, FRCS (urol) FEBU, consultant urologist at Guy's Hospital, London. BTX-A is not currently approved by the U.S. Food and Drug Administration (FDA) for the treatment of any form of OAB, nor is it currently approved for this use by regulatory agencies in Europe. This research was funded by Allergan, Inc and through a project grant from the British Urological Foundation.
(1) National Diabetes Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Disease (DIDDK), NIH,
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