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A Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Start Date
September 15, 2020
Primary Completion Date
June 1, 2023
Completion Date
June 1, 2023
Last Updated
October 12, 2023
58
ACTUAL participants
Heparin & Alkalinized Lidocaine Bladder Instillation
DRUG
Onabotulinum Toxin A
DRUG
Lead Sponsor
Walter Reed National Military Medical Center
NCT07391306
NCT05726786
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