drugset / Trial / NCT01767519
A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence
RandomizedParallel-groupDouble-blindTreatment
Summary
A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.
Timeline
- Start
- 2013-03-01
- Primary completion
- 2014-09-30
- Completion
- 2015-03-18
Publications
- Background Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naive Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. J Urol. 2017 Jul;198(1):167-175. doi: 10.1016/j.juro.2017.01.069. Epub 2017 Feb 1.
- Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 100 iu | Other |
| Comparator | Solifenacin | Small molecule | 10 mg | Oral |