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CompletedNCT01997983Updated Apr 12, 2016

Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients

A Phase 1/2 interventional study of TC-3 Gel mixed with Botox (BTX) in Interstitial Cystitis and IC, sponsored by UroGen Pharma Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-04-12.

Sponsored by UroGen Pharma Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Interstitial Cystitis
  • IC

Keywords

  • interstitial cystitis
  • PBS/IC
  • IC
  • Botox
  • Botulinum toxin
  • TC-3 Gel
  • TCGel
  • TheraCoat
03

In context

Cystitis

235 studies on the registry are indexed under Cystitis; 22 are open to participants now.

This study's enrollment of 15 is below the median of 60 across 170 interventional studies indexed under Cystitis.

Browse Cystitis studies →

Lead sponsor

UroGen Pharma Ltd. is the lead sponsor of 18 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • Experimental
    TC-3 Gel with Botox

    open label observational study

    Device: TC-3 Gel mixed with Botox (BTX)

Interventions

  • DeviceTC-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

    Also known as: botulinum toxin, BTX, TC-3 Gel

06

What researchers measure

Primary outcomes

  1. VAS score

    Change from baseline in Visual Analog Scale (VAS) score for bladder pain measured at week 12 post BTX+TC-3 instillation.

    Time frame: week 12

Secondary outcomes

  1. Number of voids in 24hour period

    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.

    Time frame: 12 weeks post instillation

  2. NUmber of urge episodes in 24-hour period

    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.

    Time frame: 12 weeks post instillation

  3. number of nocturnal voids in one night

    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.

    Time frame: 12 weeks post instillation

  4. O'Leary-Sant Interstitial Cystitis Symptom index

    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.

    Time frame: 12 weeks post instillation

07

Study locations

1 site
  • Assaf Harofeh Medical Center
    Zerifin, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01997983
Lead sponsor
UroGen Pharma Ltd.
Responsible party
Sponsor
First posted
Nov 28, 2013
Start date
Nov 2013
Primary completion
Apr 2014
Completion
Aug 2015
Last update
Apr 12, 2016

Study contacts

Amnon Zisman, MD
principal investigator · Assaf-Harofeh Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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