Phase 3
N=90
Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Interstitial Cystitis · Bladder Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT03463915 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire — -6.7; -5.8 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Bladder instillation WITH triamcinolone acetonide (Drug); Bladder instillation WITHOUT triamcinolone acetonide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Olivia Cardenas-Trowers, M.D.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire |
-6.7; -5.8 | — |
| SECONDARY Pelvic Pain and Urgency/Frequency (PUF) Questionnaire |
-5.3; -2.7 | — |
| SECONDARY Overactive Bladder Questionnaire (OAB-q) |
-24.2; -18.8 | — |
| SECONDARY Pelvic Floor Distress Inventory (PFDI) |
-5.3; -6.4 | — |
| SECONDARY Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire |
4; 4 | — |
| SECONDARY Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain |
-1.9; -1.8 | — |
| SECONDARY Number of Participants With at Least One Adverse Event |
1; 5 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03463915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.