This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Unnamed facility
Surrey, British Columbia, Canada
Unnamed facility
Vancouver, British Columbia, Canada
Unnamed facility
Victoria, British Columbia, Canada
Unnamed facility
Kentville, Nova Scotia, Canada
Change from baseline to 6 weeks in Global Response Assessment instrument (GRA)score. The GRA evaluates symptoms of intersticial cystitis
Time frame: Baseline to 6 weeks
Adverse event assessments
Time frame: Throughout the study, first instillation to Week 12
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Unnamed facility
Barrie, Ontario, Canada
Unnamed facility
Brantford, Ontario, Canada
Unnamed facility
Guelph, Ontario, Canada
Unnamed facility
Kingston, Ontario, Canada
Unnamed facility
Kitchener, Ontario, Canada
Unnamed facility
Newmarket, Ontario, Canada
...and 3 more locations