CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 27 enrolled
Drug / intervention
Onabotulinumtoxin A +2 moredrug
Likely dose
Onabotulinumtoxin 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/NCT02297100
NCT02297100Phase 4Completed
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The Impact of Injection Location on the Efficacy of Intravesicular Onabotulinumtoxin A in Interstitial Cystitis--Phase 4

Wake Forest University Health Sciences·interventional·Posted Nov 21, 2014·Updated Sep 5, 2018

In Brief

A Phase 4 clinical trial evaluating Onabotulinumtoxin A, injections upper aspect of trigone of urinary bladder, and 1 other intervention for Interstitial Cystitis. Completed, enrolled 27 participants across 1 site.

Detailed Summary

The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is a medication that comes from the bacteria Clostridium botulinum. It works by blocking the release of the neurotransmitter acetylcholine(a chemical messenger that carries signals between nerve cells and other cells in the body). Blocking that neurotransmitter results in decreased muscle activity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInterstitial Cystitis
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 21, 2014
Enrollment StartDec 1, 2014
Primary CompletionJan 10, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.6 years ago

Interventions

Onabotulinumtoxin Adrug

100 units of botox spread out among 10 separate injections

injections upper aspect of trigone of urinary bladderprocedure

We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.

injections on posterior bladder wall excluding the trigoneprocedure

We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.