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Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis
NCT05223244Phase 4
Key facts
- Status
- Completed
- Start
- Oct 2011
- Primary completion
- Apr 2019
- Sponsor
- Endeavor Health
- Modality
- Recombinant Proteins and Enzymes, Orthosteric Ligands
- Conditions
- interstitial cystitis (IC)
01
Overview
Phase 4, randomised trial of bupivacaine, triamcinolone and heparin in interstitial cystitis (IC) (2 arms), sponsored by Endeavor Health. Primary endpoint: Interstitial Cystitis Symptom Index at 6 weeks. Started Oct 2011; status: completed.
02
Design
2 arms- Study design
- Randomized
dimethyl sulfoxide (DMSO)
Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)
bupivacaine, triamcinolone, and heparin (BTH)
Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
03
Who it enrols
Women with newly diagnosed interstitial cystitis/painful bladder syndrome, excluding those with a history of pelvic radiation, bladder cancer, or bladder resection.
04
Endpoints
Primary
Interstitial Cystitis Symptom Index
Secondary
Bladder capacity
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