Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Completed · Phase 3

Conditions studied: Interstitial Cystitis, Bladder Pain Syndrome

In brief

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.

Key facts

Study ID

NCT03463915

Run by

Olivia Cardenas-Trowers, M.D.

People needed

90

Starts

2019-01-25

Expected to finish

2020-10-23

Last updated by the study team

2021-09-01

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Louisville Urogynecology at Springs Medical Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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