Over Active Bladder Instillation Study - Botox

Phase 3 Terminated 25 enrolled Mayo Clinic

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Timeline

Start: 2008-04
Primary completion: 2012-01
Completion: 2012-01

Outcome

Met primary endpoint

Stopped: “Study terminated early due to PI's extended medical leave.”

registry analysis (superiority or other test); Botox and DMSO Instillation vs DMSO Instillation; p = 0.024; t-test, 2 sided NCT00667095 ↗

Publications

Background Petrou SP, Parker AS, Crook JE, Rogers A, Metz-Kudashick D, Thiel DD. Botulinum a toxin/dimethyl sulfoxide bladder instillations for women with refractory idiopathic detrusor overactivity: a phase 1/2 study. Mayo Clin Proc. 2009 Aug;84(8):702-6. doi: 10.4065/84.8.702.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Botulinum toxin type A	Protein / enzyme biologic	300 iu	Other