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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Walter Reed National Military Medical Center
Study ID
NCT04020510
Phase
PHASE4
Status
Recruiting
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Conditions

  • Overactive Bladder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • onaBoNT-A — DRUG
    Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections

Study Details

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.

Key Dates

Start date
Jul 1, 2019
Status verified
Apr 2020
Primary completion
Jul 1, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
184 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Injections
    For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 30mL of injectable saline injected in 30 sites with 1mL per injection along the posterior wall of the bladder above the trigone.
  • Experimental: Reduced Injections
    For idiopathic overactive bladder, 100 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone. For neurogenic overactive bladder, 200 units of onabotulinumtoxinA mixed in 10mL of injectable saline injected in 5 sites with 2mL per injection in an "X" configuration on posterior wall of the bladder above the trigone.

Primary Outcome Measure

Mean change from baseline in overactive bladder symptom severity and health related quality of life scores on the overactive bladder questionnaire short form [ Time Frame: 4-12 weeks post-procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Walter Reed National Military Medical CenterBethesdaMaryland20889
Angela M DiCarlo-Meacham, MD
[email protected]
636-288-2955
Christine Vaccaro, DO
[email protected]
301-400-2469
Daniel Gruber, MD (SUB_INVESTIGATOR)
David Osborn, MD (SUB_INVESTIGATOR)
Katherine Dengler, MD (SUB_INVESTIGATOR)
Leah Scarlotta, MD (SUB_INVESTIGATOR)
Hector Gonzalez, MD (SUB_INVESTIGATOR)

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Walter Reed National Military Medical Center· Bethesda, MD

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