CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Botulinum toxin A +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01969773
NCT01969773Phase 2Completed
CompareCT.gov

Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Buddhist Tzu Chi General Hospital·interventional·Posted Oct 25, 2013·Updated Feb 17, 2017

In Brief

A Phase 2 clinical trial evaluating Botulinum toxin A and Normal saline instillation for Interstitial Cystitis. Completed, enrolled 60 participants across 1 site.

Detailed Summary

This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInterstitial Cystitis
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2013
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 12.7 years ago

Interventions

Botulinum toxin Adrug

Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)

Normal saline instillationdrug

Patients will be randomly assigned to receive intravesical injection of injection with normal saline.