Phase 2
Completed N=59
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions
Cystitis, Interstitial · Ulcer
Source: ClinicalTrials.gov NCT02395042 ↗
Enrolled (actual)
59
Serious AEs
0.9%
Results posted
Oct 2018
Primary outcomePrimary: Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) — -1.6; -2.7; -2.5 score on a scale — p=0.142
Summary
This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS) |
-1.6; -2.7; -2.5 | 0.142 |
| SECONDARY Change From Baseline in the Number of Hunner's Lesions |
0.8; -0.6; -0.2 | 0.024 sig |
| SECONDARY Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of interstitial cystitis with Hunner's lesions/ulcers
Exclusion Criteria
- Previous treatment with LiRIS®
- Interstitial cystitis/bladder pain syndrome, without Hunner's lesions/ulcers
Data sourced from ClinicalTrials.gov (NCT02395042). 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. Informational only — not medical advice.