CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Botulinum toxin A +1 moredrug
Likely dose
Botulinum toxin A 100 unitsfrom 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/NCT02135341
NCT02135341Phase 2Completed
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Comparative Study of Safety and Efficacy Between 100 U Suburothelial Injection and 50 U Suburothelial Plus 50 U Urethral Injections of Botulinum Toxin A in Treatment of Patients With Detrusor Overactivity and Impaired Contractility

Buddhist Tzu Chi General Hospital·interventional·Posted May 9, 2014·Updated Feb 15, 2017

In Brief

A Phase 2 clinical trial evaluating Botulinum toxin A for Botulinum Toxins, Type A. Completed, enrolled 60 participants across 1 site.

Detailed Summary

The objectives of this study is to evaluate and compare the efficacy and safety between 100 U of botulinum toxin A (BoNT-A) suburothelial injections and combined 50 U of BoNT-A suburothelial injections and 50 U urethral injection for the treatment of detrusor overactivity and inadequate contractility (DHIC) refractory to antimuscarinic agents

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBotulinum Toxins, Type A
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 9, 2014
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 12.1 years ago

Interventions

Botulinum toxin Adrug

BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment

Botulinum toxin Adrug

BoNT-A 100 units in normal saline 10ml, suburothelial injection 50 U in 10 sites and 50 U urethral injections in 5 sites