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Trial record 95 of 158 for:    interstitial cystitis

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
Sponsor:
Information provided by (Responsible Party):
UroGen Pharma Ltd.

Brief Summary:

The investigators believe that this study is of importance of several aspects:

  1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode.
  2. It will demonstrating safety of intravesical instillations of BTX mixed with TC-3 gel in IC patients
  3. 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

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Other Names:
  • botulinum toxin
  • BTX
  • TC-3 Gel




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject diagnosed with Interstitial Cystitis/PBS.
  2. Subject has signed Informed Consent Form and is willing and able to abide by the protocol.
  3. Subject has IC Symptom index (of IC Symptom and Problem Questionnaire) score of 12-20 points.
  4. Subject has IC Problem index (of IC Symptom and Problem Questionnaire) score of 12-16 points.
  5. Subject is willing and able to complete the micturition diary and questionnaire correctly.
  6. Subject agrees to be available for the follow-up evaluations as required by the protocol.
  7. Subject is mentally competent with the ability to understand and comply with the requirements of the study.
  8. No active urinary tract infection as confirmed by urine culture.
  9. If the subject is a female of childbearing potential she has a negative pregnancy test at screening.

Exclusion Criteria:

  1. Patient who is pregnant, lactating, or planning to become pregnant within the study period.
  2. Patient used Clean Intermittent Catheterization (CIC).
  3. Patient has a known neurological cause for IC/PBS symptoms.
  4. Patient has Patient with implanted permanent neuro-stimulation device
  5. Patient with pelvic organ prolapse stage III or IV, (i.e. the most distal part of the prolapse protruding more than 1 cm beyond the hymen at straining)
  6. Patient with lower tract genitourinary malignancies
  7. Patient with prior anti-incontinence surgery and interventions including mid-urethral slings, burch bladder suspension, sacral neuromodulation, or tibial nerve stimulation.
  8. Patient received intradetrusor Botox (Botolinum Toxin A) injection within 12 months prior to the study initiation.
  9. Patient with previous pelvic radiation therapy
  10. Patient who is morbidly obese (BMI > 40 Kg/m2).
  11. Patient with current culture-proven urinary tract infection, including cystitis or urethritis.
  12. Patient had been treated for 2 or more UTIs within last 6 months.
  13. Patient with a life expectancy of less than 12 months.

Information from the National Library of Medicine

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


Locations
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Israel
Assaf Harofeh Medical Center
Zerifin, Israel
Sponsors and Collaborators
UroGen Pharma Ltd.
Investigators
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Principal Investigator: Amnon Zisman, MD Assaf-Harofeh Medical Center

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Responsible Party: UroGen Pharma Ltd.
ClinicalTrials.gov Identifier: NCT01997983     History of Changes
Other Study ID Numbers: TC-IC-01
First Posted: November 28, 2013    Key Record Dates
Last Update Posted: April 12, 2016
Last Verified: April 2016

Keywords provided by UroGen Pharma Ltd.:
interstitial cystitis
PBS/IC
IC
Botox
Botulinum toxin
TC-3 Gel
TCGel
TheraCoat

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents