CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Standard number of injection sites +1 moreprocedure
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/NCT06059066
NCT06059066N/ACompleted
CompareCT.gov

Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction

The Methodist Hospital Research Institute·interventional·Posted Sep 28, 2023·Updated May 9, 2025

In Brief

A clinical study evaluating Standard number of injection sites and Reduced number of injection sites for Neurogenic Bladder and 4 related conditions. Completed, enrolled 78 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate and standardize the way providers perform OnabotulinumtoxinA (BTX-A) injections into the bladder for the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)/overactive bladder (OAB). NLUTD/OAB is a syndrome that affects many people, and includes urinary frequency, urinary urgency, urgency incontinence, and nocturia. This syndrome can be challenging to treat and often requires procedural management - including BTX-A injections into the bladder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder, Neuro: Neurogenic Bladder, Neurogenic Detrusor Overactivity
CountriesUnited States
CollaboratorsCollaborating for Advancement of Interdisciplinary Research in Benign Urology

Timeline

N/ACompletedFinished
202420252026
First PostedSep 28, 2023
Enrollment StartOct 4, 2023
Primary CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.8 years ago

Interventions

Standard number of injection sitesprocedure

200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone.

Reduced number of injection sitesprocedure

200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone.