Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients
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|ClinicalTrials.gov Identifier: NCT01997983|
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : April 12, 2016
The investigators believe that this study is of importance of several aspects:
- It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
- It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel in IC patients
- If proved effective or partially effective, this mode of treatment will serve as a basis for large feasibility study exploring its safety and efficacy aspects.
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis IC||Device: TC-3 Gel mixed with Botox (BTX)||Phase 1 Phase 2|
American Urology Association (AUA) considers intradetrusor injection of BTX as a fifth-line treatment of interstitial cystitis due to the seriousness and of adverse events, including dysuria, large post-void residuals, and the need for intermittent self-catheterization. An appealing alternative for BTX injection is intravesical instillation of BTX since the recent studies suggest that intravesically applied BTX acts through the afferent neuropathway involving sensory mechanism in the urothelium rather than the smooth muscle. TheraCoat core technology is based on a reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature) for drug retention in the urinary bladder. Intravesical BTX instillation using TheraCoat gel is expected to increase treatment efficiency due to prolongation of treatment duration and consequently improving bladder exposure to BTX.
Prior to instillation, the TC-3 hydrogel, in a liquid state, is mixed with BTX.TC-3 mixed with BTX is instilled to the bladder by a catheter. Following gel insertion to the bladder, the gel solidifies and forms a drug reservoir inside the bladder. Upon contact with urine the gel dissolves and is cleared out from the bladder Post instillation, patients followed at 2, 6, 12 weeks thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study Evaluating Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in Interstitial Cystitis Patients|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||August 2015|
Experimental: TC-3 Gel with Botox
open label observational study
Device: TC-3 Gel mixed with Botox (BTX)
TC-3 gel mixed with Botox (BTX). Single intravesical instillations of 40 ml of TC-3 mixed with 200 units of preconstitued BTX, using catheter
- VAS score [ Time Frame: week 12 ]Change from baseline in Visual Analog Scale (VAS) score for bladder pain measured at week 12 post BTX+TC-3 instillation.
- Number of voids in 24hour period [ Time Frame: 12 weeks post instillation ]Change from baseline in number of voids in 24-hour period per 3-day voiding diary measured at week 12 post BTX+TC-3 instillation.
- NUmber of urge episodes in 24-hour period [ Time Frame: 12 weeks post instillation ]Change from baseline in number of urge episodes in 24-hour period per 3-day voiding diary measured at week 12 post BTX+TC-3 instillation.
- number of nocturnal voids in one night [ Time Frame: 12 weeks post instillation ]Change from baseline in number of nocturnal voids in one night per 3-day voiding diary measured at week 12 post BTX+TC-3 instillation.
- O'Leary-Sant Interstitial Cystitis Symptom index [ Time Frame: 12 weeks post instillation ]Change from baseline in O'Leary-Sant Interstitial Cystitis Symptom index per O'Leary-Sant Interstitial Cystitis Symptom and Problem questionnaire measured at week 12 post BTX+TC-3 instillation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997983
|Assaf Harofeh Medical Center|
|Principal Investigator:||Amnon Zisman, MD||Assaf-Harofeh Medical Center|