Status:
COMPLETED
Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Lead Sponsor:
Olivia Cardenas-Trowers, M.D.
Conditions:
Interstitial Cystitis
Bladder Pain Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 comple...
Detailed Description
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS disproportionately affects women with over 80% of patients with IC/BPS as fema...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03463915
Start Date
January 25 2019
End Date
October 23 2020
Last Update
September 1 2021
Active Locations (1)
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1
University of Louisville Urogynecology at Springs Medical Center
Louisville, Kentucky, United States, 40205