Clinical Trials Logo
  1. Home
  2. Interstitial Cystitis
  3. NCT04401176

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

Interstitial Cystitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04401176
Study type Interventional
Source Walter Reed National Military Medical Center
Contact
Status Completed
Phase Phase 2
Start date September 15, 2020
Completion date June 1, 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT04313972 - IC PaIN Trial: Interstitial Cystitis Pain Improvement With Naltrexone Phase 4
Completed NCT03282318 - A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis Phase 2
Completed NCT03463499 - The Efficacy and Safety of Intravesical Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients N/A
Completed NCT02898220 - Trans-MAPP II Study of Urologic Chronic Pelvin Pain
Terminated NCT02591199 - Engage 24: Evaluation of the Safety and Effectiveness of URG101 in Subjects With Interstitial Cystitis/Bladder Pain Syndrome Phase 2
Completed NCT02247557 - Intravesical Instillation of Liposome Encapsulated Botulinum Toxin A (Lipotoxin) in Treatment of Interstitial Cystitis Phase 2
Active, not recruiting NCT01731470 - Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS) N/A
Completed NCT01197261 - OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS) Phase 2
Completed NCT00971568 - Urinary Biomarkers Characteristic to Interstitial Cystitis N/A
Completed NCT00527917 - A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome. Phase 2
Completed NCT00150488 - URACYST® For the Treatment of GAG Deficient Interstitial Cystitis N/A
Recruiting NCT00094874 - Acupuncture for the Treatment of Interstitial Cystitis (IC) Symptoms Phase 3
Terminated NCT00086684 - Effectiveness and Safety Study of Pentosan Polysulfate Sodium for the Treatment of Interstitial Cystitis Phase 4
Recruiting NCT04845217 - Peppermint Oil for the Treatment of Interstitial Cystitis / Bladder Pain Syndrome Phase 1/Phase 2
Recruiting NCT05147779 - Safety of Cultured Allogeneic Adult Umbilical Cord Stem Cells for Peyronie's Disease, ED, and Interstitial Cystitis Phase 1
Suspended NCT04450316 - Low-dose Naltrexone for Bladder Pain Syndrome Phase 2
Completed NCT04010513 - Hypnosis for Bladder Pain Syndrome N/A
Completed NCT05179460 - A Study of Pentosan Polysulfate Sodium and the Development of Pigmentary Maculopathy and Pigmentary Retinopathy
Completed NCT02232282 - Acupuncture for Female IC/PBSyndrome and Its Effect on the Urinary Microbiome: A Randomized Controlled Trial N/A
Completed NCT00546858 - Relationship of Interstitial Cystitis to Vulvodynia N/A