Overactive Bladder Clinical Trial
Official title:
A Randomized Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botulinum Toxin (Botox®) Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")
The study will investigate the safety and efficacy of UroGen's TC-3 Gel for sustained release of Botulinum Toxin A (BTX) in urinary bladder in patients with idiopathic overactive bladder.
Overactive bladder (OAB) is a syndrome, defined by the International Continence Society
(ICS), as the presence of "urinary urgency, usually accompanied by frequency and nocturia,
with or without urgency urinary incontinence, in the absence of a urinary tract infection
(UTI) or other obvious pathology." This study will evaluate a new of mode of treatment, with
intravesical bladder instillation with Botox® mixed with TC-3 that may bypass the drawbacks
of the current bladder injection treatment mode in OAB patients. Additionally it will
provide preliminary safety and efficacy data that may serve as a basis for a larger study
exploring safety and efficacy aspects of this new mode of treatment.
50 patients will be randomized in a horse race fashion in a ~2:2:1 ratio. The patients will
be screened for up to 3 weeks prior to treatment.
The patients will be requested to stop their OAB medications 7 days prior to treatment
visit. 20 patients will receive one instillation of 300U of BotuGel (60ml), 20 patients will
receive one instillation of 400U of BotuGel (60ml) and 10 patients will receive one
instillation of 60 ml RTGel-TC-3 Gel (Placebo), all patients will be followed up for safety
and efficacy endpoints until 6 weeks post instillation.
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