- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02179099
Safety and Efficacy of Intravesical Botulinum Toxin in TC-3 Gel in OAB Patients
February 28, 2016 updated by: UroGen Pharma Ltd.
Pilot Study Evaluating Safety and Efficacy of Intravesical Instillations of Botulinum Toxin in TC-3 Gel in OAB Patients
This is a single arm pilot study evaluating the feasibility and preliminary safety of a single intravesical instillation of TC-3 gel mixed with botulinum toxin (BTX) for symptomatic improvement in overactive bladder patients.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
BTX is considered as therapeutic option for overactive bladder (OAB).
Randomized placebo-controlled studies have shown that BTX administered by intramural injection into the bladder wall in patients with OAB leads to significant improvement in urodynamic parameters and quality of life.
(Schurch 2008).
On the other hand, the animal study suggests that intravesically applied BTX acts to decrease frequency of bladder contraction by inhibiting sensory mechanism in the urothelium rather than directly through inhibition of the smooth muscle contraction.
(Khera 2005).
The efficacy of intravesical BTX instillation was only tested in a few open label trials for overactive bladder patients whereby the clinical improvement observed was short-lasting with a mean duration of 6.8 weeks (Petrou 2009, Krhut 2011).
The short exposure duration of the urothelium to BTX could be one of the factors responsible for the lack of a sustained effect.
TC-3 is a hydrogel with reverse thermal gelation properties that when mixed with BTX and instilled intravesically serves as the drug reservoir allowing for gradual release of BTX and thereby for its extended contact with bladder urothelium.
Study Type
Interventional
Enrollment (Actual)
3
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Holon, Israel
- Urology Department, Edith Wolfson Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female 18 to 85 years old with symptoms of idiopathic OAB for ≥ 3 months prior to screening.
- Patient has signed Informed Consent Form and is willing and able to comply with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires.
- Patient is non-responder to anticholinergic or beta-agonist drug therapy or is not compliant to the treatment due has intolerable side effects.
- Patient has urination frequency of at least 8 micturitions per 24 hours.
- Patients has at least 3 urinary urgency incontinence (UUI) episodes per 3-day bladder diary, with no more than 1 incontinence-free day.
- Patients has PVR ≤100 ml. Patient with a single PVR of >100 ml and followed by two consecutive PVR measurements of <100 ml may be included in the study).
- If patient is a female of childbearing potential, she has a negative urine pregnancy test at screening visit and practice a reliable method of contraception throughout the study, until 6 months post treatment.
- Patient is mentally competent with the ability to understand and comply with the requirements of the study.
- Patient does not have active urinary tract infection as confirmed by urine culture. In case of UTI proven by urine culture, the patient will be treated with full course of antibiotics, and the instillation will be postponed for 1 week following negative urine culture demonstration.
Exclusion Criteria:
- Pregnant (positive urine pregnancy test), planning to become pregnant during the study period, breast-feeding, or of childbearing potential and not practicing reliable contraception**.
- Patient has a clinically significant Bladder Outlet Obstruction (BOO).
- Patient has neurogenic bladder.
- Patient currently uses Clean Intermittent Catheterization (CIC).
- Patient has documented unstable diabetes with or without diabetic neuropathy.
- Patient who is currently undergoing biofeedback, pelvic muscle rehabilitation, pelvic floor physical therapy, or electrical-stimulation.
- Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period.
- Patient with vesico-ureteral reflux, interstitial cystitis, genitourinary fistulae
- 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 with prior Botox anti-incontinence therapy.
- Patient with previous pelvic radiation therapy
- Patient who is morbidly obese (BMI > 40 Kg/m2).
- Patient had been treated for 2 or more UTIs within last 6 months.
- Patient on immunomodulatory therapy (suppressive or stimulatory)
- Patient participated in prior clinical trials with BTX+TC-3 gel
- Patient has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc).
- Subject has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
- Patient with a life expectancy of less than 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BTX mixed with TC-3 Gel
Patients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX
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Patients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 16 weeks
|
|
16 weeks
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Efficacy
Time Frame: 16 weeks
|
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
exploratory efficacy
Time Frame: 16 weeks
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16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ami Sidi, Prof MD, Wolfson Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (ACTUAL)
November 1, 2015
Study Completion (ACTUAL)
February 1, 2016
Study Registration Dates
First Submitted
June 29, 2014
First Submitted That Met QC Criteria
June 29, 2014
First Posted (ESTIMATE)
July 1, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
March 1, 2016
Last Update Submitted That Met QC Criteria
February 28, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Urinary Bladder Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Bladder, Overactive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
Other Study ID Numbers
- TC-OAB-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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