- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02674269
Safety and Efficacy Study of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botox® Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2") (INTIMO2)
A Randomized Double-Blind, Placebo Controlled Study Evaluating the Safety and Efficacy of Intravesical Instillations of BotuGelTM, Slow Release RTGel Based Botulinum Toxin (Botox®) Formulations, in Idiopathic OAB Patients With Urinary Incontinence ("INTIMO2")
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overactive bladder (OAB) is a syndrome, defined by the International Continence Society (ICS), as the presence of "urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of a urinary tract infection (UTI) or other obvious pathology." This study will evaluate a new of mode of treatment, with intravesical bladder instillation with Botox® mixed with TC-3 that may bypass the drawbacks of the current bladder injection treatment mode in OAB patients. Additionally it will provide preliminary safety and efficacy data that may serve as a basis for a larger study exploring safety and efficacy aspects of this new mode of treatment.
50 patients will be randomized in a horse race fashion in a ~2:2:1 ratio. The patients will be screened for up to 3 weeks prior to treatment.
The patients will be requested to stop their OAB medications 7 days prior to treatment visit. 20 patients will receive one instillation of 300U of BotuGel (60ml), 20 patients will receive one instillation of 400U of BotuGel (60ml) and 10 patients will receive one instillation of 60 ml RTGel-TC-3 Gel (Placebo), all patients will be followed up for safety and efficacy endpoints until 6 weeks post instillation.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Haifa, Israel
- Rambam Health Care Campus
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Kfar Saba, Israel
- Meir Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Main Inclusion Criteria:
- Female patient 18 to 75 years old diagnosed with idiopathic OAB.
- Patient has symptoms of OAB for ≥ 3 months prior to screening.
- Patient is a non-responder to pharmacologic therapy or has intolerable side effects or is not compliant to the treatment.
- On screening three-day voiding diary- Patient has a frequency of at least 8 micturitions per 24 hours & Total of ≥3 urgency urinary incontinence (UUI) episodes.
- Patient is willing and able to initiate self catheterization post-treatment, if required.
- 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).
Main Exclusion Criteria:
- Patient currently uses CIC or indwelling catheter to manage their urinary incontinence
- Patient who has clinically significant Bladder Outlet Obstruction (BOO).
- Patient with active urinary tract infection.
- OAB due to any known neurological reason.
- Patient with 24-hour total urine volume voided greater than 3,000 ml as measured at screening visit.
- Predominance of stress incontinence in the opinion of the investigator, determined by patient history.
- Use of anticholinergics or other medications or therapies to treat symptoms of OAB within 7 days of screening.
- Patient with prior botulinum toxin therapy of any serotype within 12 weeks for any indication.
- Patient with prior use of Botulinum toxin therapy of any serotype for any urological condition.
- Patient with previous pelvic radiation therapy.
- Patient had been treated for two or more UTIs within last 6 months or use of prophylactic antibiotics to prevent chronic UTIs.
- ANY condition identified which may cause overactive bladder symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 300 IU of BotuGelTM (60ml)
One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
|
One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
Other Names:
|
Experimental: 400 IU of BotuGelTM (60ml)
One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
|
One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
Other Names:
|
Placebo Comparator: TC-3 Gel
One intravesical instillation of 60 ml TC-3 gel
|
Intravesical instillation of 60 ml TC-3 gel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary retention
Time Frame: 6 weeks
|
Urinary retention events defined as a PVR >200 and <350 ml with patient reported symptoms that in the investigator's opinion require initiation of CIC, or PVR≥350 regardless of symptoms.
|
6 weeks
|
Urinary tract infection (UTI) events
Time Frame: 6 weeks
|
Urinary tract infection (UTI) events* *Asymptomatic bacteruria will not be considered UTI and will be reported as separate AEs. |
6 weeks
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Post-void residual (PVR)
Time Frame: 6 weeks
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PVR-Change from baseline in PVR as measured by bladder ultrasonography at week 4 post instillation
|
6 weeks
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Adverse events
Time Frame: 6 weeks
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Adverse events during and post instillation procedure.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-day voiding Diary
Time Frame: Week 4 and 6 post-instillation
|
3-day voiding Diary
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Week 4 and 6 post-instillation
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Kings Health Questionnaire (KHQ score) comparing to baseline
Time Frame: Week 4 and 6 post-instillation
|
KHQ score comparing to baseline
|
Week 4 and 6 post-instillation
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Incontinence Quality of Life Questionnaire (I-QOL)
Time Frame: Week 4 and 6 post-instillation
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I-QOL score comparing to baseline
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Week 4 and 6 post-instillation
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Treatment Benefit Scale (TBS)
Time Frame: Week 4 and 6 post-instillation
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Proportion of patients who had positive treatment response per Treatment Benefit Scale (TBS)
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Week 4 and 6 post-instillation
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Comparison of resulted delta scores between the treatment arms and Placebo
Time Frame: Week 4 and 6 post-instillation
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Week 4 and 6 post-instillation
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ifat Klein, PhD, iklein@urogen.com
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-OAB-03-P
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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