RecruitingPhase 4NCT04020510

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA Treatment of Overactive Bladder

Standard Injections Versus Reduced Injections for Intravesical onabotulinumtoxinA for Treatment of Idiopathic and Neurogenic Overactive Bladder: a Randomized Trial


Sponsor

Walter Reed National Military Medical Center

Enrollment

184 participants

Start Date

Jul 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

OnabotulinumtoxinA is an effective treatment for both idiopathic and neurogenic overactive bladder and was FDA approved for this indication in 2013. The standard technique for injecting onabotulinumtoxinA into the detrusor is mixing 100 units of onabotulinumtoxinA into 10mL of injectable normal saline and injecting 20 sites with 0.5mL in the posterior wall of hte bladder for idiopathic overactive bladder and mixing 200 units into 30mL and injecting 30 sites with 1mL for neurogenic overactive bladder. The purpose of this study is to compare the efficacy of a technique using a reduced number of injections with the same dosage of onabotulinumtoxinA to the standard technique. The hypothesis is that the reduced technique will not be inferior in terms of efficacy as the standard technique and that there will be a lower incidence of urinary tract infections and urinary retention requiring catheterization post-procedure.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called onaBoNT-A for people with overactive bladder. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGonaBoNT-A

Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections


Locations(1)

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

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NCT04020510


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