Clinical Trial Comparing Two Bladder Instillations for IC/BPS

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03463915
• Date of registration: 28/02/2018
• Prospective Registration: Yes
• Primary sponsor: Olivia Cardenas-Trowers, M.D.
• Public title: Clinical Trial Comparing Two Bladder Instillations for IC/BPS
• Scientific title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome
• Date of first enrolment: January 25, 2019
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03463915
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Sean Francis, M.D.
• Affiliation: University of Louisville

• Name: Olivia Cardenas-Trowers, M.D.
• Affiliation: University of Louisville

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Interstitial Cystitis

Bladder Pain Syndrome

Intervention(s)

Drug: Bladder instillation WITHOUT triamcinolone acetonide

Drug: Bladder instillation WITH triamcinolone acetonide

Primary Outcome(s)

Change from baseline in treatment response as measured by the total score on the O'Leary-Sant questionnaire [Time Frame: Baseline, 3 weeks, and 6 weeks]

Secondary Outcome(s)

Change from baseline in treatment response as measured by the Visual Analogue Scale (VAS) for pain [Time Frame: Baseline, 3 weeks, and 6 weeks]

Overactive bladder questionnaire (OAB-q) [Time Frame: Baseline, 3 weeks, and 6 weeks]

Pelvic floor distress inventory (PFDI) [Time Frame: Baseline, 3 weeks, and 6 weeks]

Pelvic pain and urgency/frequency (PUF) questionnaire [Time Frame: Baseline, 3 weeks, and 6 weeks]

Number of participants with at least one adverse event [Time Frame: End of study (6 weeks)]

Sexual function measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) questionnaire [Time Frame: Baseline, 3 weeks, and 6 weeks]

Secondary ID(s)

18.0209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors