CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 58 enrolled
Drug / intervention
Heparin & Alkalinized Lidocaine Bladder Instillation +1 moredrug
Likely dose
Onabotulinum Toxin A 0.5mLfrom 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/NCT04401176
NCT04401176Phase 2Completed

A Randomized Trial of Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Walter Reed National Military Medical Center·interventional·Posted May 26, 2020·Updated Oct 12, 2023

In Brief

A Phase 2 clinical trial evaluating Heparin & Alkalinized Lidocaine Bladder Instillation and Onabotulinum Toxin A for Interstitial Cystitis and Bladder Pain Syndrome. Completed, enrolled 58 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 26, 2020
Enrollment StartSep 15, 2020
Primary CompletionJun 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 6.1 years ago

Interventions

Heparin & Alkalinized Lidocaine Bladder Instillationdrug

Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void

Onabotulinum Toxin Adrug

Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)