Clinical Trial Comparing Two Bladder Instillations for IC/BPS

• Status: Completed
• Trial end date: 2020-10-23
• Target enrollment: 0
• Participant gender: Female

Summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops is not completely known. Bladder instillation is a commonly used treatment in which a mixture of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room to learn more about bladder instillations and which ingredients in them work best. The purpose of this study is to compare the effectiveness of a bladder instillation that contains a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated with bladder instillations that do not contain a steroid.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Olivia Cardenas-Trowers, M.D.
• Treatments: Gabapentin; gamma-Aminobutyric Acid; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

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