Interstitial CystitisPhase 1/2NCT01997983
Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in IC Patients
A Phase 1/2 study testing TC-3 Gel mixed with Botox (BTX) in people with Interstitial Cystitis and IC, run by UroGen Pharma Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Interstitial Cystitis, IC
- What is being tested?
- TC-3 Gel mixed with Botox (BTX)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Aug 2015
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Evaluating Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in Interstitial Cystitis Patients
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.
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.
- Conditions
- Interstitial Cystitis, IC
- Being tested
- TC-3 Gel mixed with Botox (BTX)
- Keywords
- interstitial cystitis, PBS/IC, IC, Botox, Botulinum toxin, TC-3 Gel, TCGel, TheraCoat
- Medical subject headings
- Cystitis, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-3 Gel mixed with Botox (BTX)Device
Also called botulinum toxin, BTX, TC-3 Gel
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
| Study group | Role | What they receive |
|---|---|---|
| TC-3 Gel with Botox | Experimental | open label observational study Receives: Device: TC-3 Gel mixed with Botox (BTX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Change from baseline in Visual Analog Scale (VAS) score for bladder pain measured at week 12 post BTX+TC-3 instillation.
Measured: week 12
Secondary outcomes (4)
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.
Measured: 12 weeks post 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.
Measured: 12 weeks post 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.
Measured: 12 weeks post 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.
Measured: 12 weeks post instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- UroGen Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amnon Zisman, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997983
- Sponsor's protocol ID
- TC-IC-01
- Status last verified
- Apr 2016
- First submitted
- 24 Nov 2013
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating Efficacy and Safety of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in Interstitial Cystitis Patients
- ClinicalTrials.gov ID
- NCT01997983
- Acronym / sponsor ID
- TC-IC-01
- Conditions
- Interstitial Cystitis, IC
- Keywords
- interstitial cystitis, PBS/IC, IC, Botox, Botulinum toxin, TC-3 Gel, TCGel, TheraCoat
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- UroGen Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TC-3 Gel with Botox | Experimental | Device: TC-3 Gel mixed with Botox (BTX)open label observational study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-3 Gel mixed with Botox (BTX)Also: botulinum toxin, BTX, TC-3 GelTC-3 gel mixed with Botox (BTX). Single intravesical instillations of 40 ml of TC-3 mixed with 200 units of preconstitued BTX, using catheter | Device | TC-3 Gel with Botox |
Primary outcome
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.
4 secondary outcomes
Number of voids in 24hour period
Time frame: 12 weeks post instillation
NUmber of urge episodes in 24-hour period
Time frame: 12 weeks post instillation
number of nocturnal voids in one night
Time frame: 12 weeks post instillation
O'Leary-Sant Interstitial Cystitis Symptom index
Time frame: 12 weeks post instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amnon Zisman, MD principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TC-3 Gel mixed with Botox (BTX) in people with Interstitial Cystitis and IC, run by UroGen Pharma Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.