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

Primary Purpose

Interstitial Cystitis, IC

Status

Completed

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

TC-3 Gel mixed with Botox (BTX)

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring interstitial cystitis, PBS/IC, IC, Botox, Botulinum toxin, TC-3 Gel, TCGel, TheraCoat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Assaf Harofeh Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TC-3 Gel with Botox

Arm Description

open label observational study

Outcomes

Primary Outcome Measures

VAS score

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

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT01997983

First Posted

November 24, 2013

Last Updated

April 11, 2016

Sponsor

UroGen Pharma Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01997983

Brief Title

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

Official Title

Pilot Study Evaluating Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in Interstitial Cystitis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

November 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UroGen Pharma Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Cystitis, IC

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TC-3 Gel with Botox

Arm Type

Experimental

Arm Description

open label observational study

Intervention Type

Device

Intervention Name(s)

TC-3 Gel mixed with Botox (BTX)

Other Intervention Name(s)

botulinum toxin, BTX, TC-3 Gel

Intervention Description

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

Primary Outcome Measure Information:

Title

VAS score

Description

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 Outcome Measure Information:

Title

Number of voids in 24hour period

Description

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

Title

NUmber of urge episodes in 24-hour period

Description

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

Title

number of nocturnal voids in one night

Description

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

Title

O'Leary-Sant Interstitial Cystitis Symptom index

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amnon Zisman, MD

Organizational Affiliation

Assaf-Harofeh Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf Harofeh Medical Center

City

Zerifin

Country

Israel

12. IPD Sharing Statement

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

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