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

NCT01997983 | Completed Phase 1 DMC

• 1 other identifier: TC-IC-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Interstitial Cystitis; IC

Keywords

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

Outcome Measures

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.

  week 12

Secondary Outcomes (4)

• Number of voids in 24hour period

  12 weeks post instillation

• NUmber of urge episodes in 24-hour period

  12 weeks post instillation

• number of nocturnal voids in one night

  12 weeks post instillation

• O'Leary-Sant Interstitial Cystitis Symptom index

  12 weeks post instillation

Study Arms (1)

TC-3 Gel with Botox

EXPERIMENTAL

open label observational study

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

Interventions

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

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

TC-3 Gel with Botox

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patient who is pregnant, lactating, or planning to become pregnant within the study period.
• Patient used Clean Intermittent Catheterization (CIC).
• Patient has a known neurological cause for IC/PBS symptoms.
• Patient has Patient with implanted permanent neuro-stimulation device
• 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)
• Patient with lower tract genitourinary malignancies
• Patient with prior anti-incontinence surgery and interventions including mid-urethral slings, burch bladder suspension, sacral neuromodulation, or tibial nerve stimulation.
• Patient received intradetrusor Botox (Botolinum Toxin A) injection within 12 months prior to the study initiation.
• Patient with previous pelvic radiation therapy
• Patient who is morbidly obese (BMI \> 40 Kg/m2).
• Patient with current culture-proven urinary tract infection, including cystitis or urethritis.
• Patient had been treated for 2 or more UTIs within last 6 months.
• Patient with a life expectancy of less than 12 months.

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, Israel

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Amnon Zisman, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: November 28, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: August 1, 2015
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

IL (1)