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NCT04020510

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

Recruiting now Phase 4 Last updated 28 April 2020
What this trial tests

Phase 4 trial testing onaBoNT-A in Overactive Bladder in 184 participants. Currently enrolling.

Timeline
1 July 2019
Primary endpoint
1 July 2021
31 December 2021

Quick facts

Lead sponsorWalter Reed National Military Medical Center
PhasePhase 4
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment184
Start date1 July 2019
Primary completion1 July 2021
Estimated completion31 December 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Walter Reed National Military Medical Center

Who can join

18 and older, any sex, with Overactive Bladder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Reduced versus standard intradetrusor OnabotulinumtoxinA injections for treatment of overactive bladder.
    DiCarlo-Meacham AM, Dengler KL, Welch EK, Brooks DI, et al · · 2023 · cited 14× · PMID 36455284 · DOI 10.1002/nau.25107

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Other trials of onaBoNT-A

Trials testing the same drug.

Other recruiting trials for Overactive Bladder

Currently open trials in the same condition.

Other Walter Reed National Military Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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