Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Interstitial Cystitis, Bladder Pain Syndrome
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog, Steroid
Eligibility Criteria
Inclusion Criteria:
- Women 18 years and older
- Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index) of the O'Leary-Sant questionnaire who have selected bladder instillations as part of their IC/BPS treatment
- Suitability for follow-up
Exclusion Criteria:
- Contraindications and/or allergies to the ingredients used in the bladder instillations
- Diagnosis of idiopathic thrombocytopenic purpura
- Does not desire to undergo bladder instillation therapy or unwilling to undergo bladder instillation therapy on schedule mandated by study
- Have a known alternative diagnosis explaining bladder pain symptoms that would preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract infection with bacteria or fungus treated within last 2 weeks or diagnosed at index visit, bladder injury or trauma within the last 30 days)
- Inability to speak or read English
- Bladder instillation within the past 4 weeks
Sites / Locations
- University of Louisville Urogynecology at Springs Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Bladder instillation WITH triamcinolone acetonide
Bladder instillation WITHOUT triamcinolone acetonide
Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).