CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
OnabotulinumtoxinA 100 Unitsdrug
Likely dose
OnabotulinumtoxinA 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/NCT04124939
NCT04124939Phase 4Completed
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A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?

Wake Forest University Health Sciences·interventional·Posted Oct 14, 2019·Updated Apr 17, 2024

In Brief

A Phase 4 clinical trial evaluating OnabotulinumtoxinA 100 Units for Overactive Bladder. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOveractive Bladder
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedOct 14, 2019
Enrollment StartNov 10, 2019
Primary CompletionNov 9, 2022
Study CompletionFeb 23, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.7 years ago

Interventions

OnabotulinumtoxinA 100 Unitsdrug

BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.