Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01997983 | Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients | PHASE1 | COMPLETED | 15 | — | — | Nov 1, 2013 | Aug 1, 2015 | Apr 12, 2016 | 1 | Israel |
Change from baseline in Visual Analog Scale (VAS) score for bladder pain measured at week 12 post BTX+TC-3 instillation.
| Arm | Type | Description |
|---|---|---|
| TC-3 Gel with Botox | EXPERIMENTAL | open label observational study |
| Name | Type | Description |
|---|---|---|
| TC-3 Gel mixed with Botox (BTX) | DEVICE | 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 |
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...