CompletedPhase 3

Clinical Trial Comparing Two Bladder Instillations for IC/BPS

United States90 participantsStarted 2019-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire

Timeframe: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported

Trial details

NCT IDNCT03463915

SponsorOlivia Cardenas-Trowers, M.D.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-23

Results submitted2021-06-25