A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis With Hunner's Lesions

Phase 2CompletedNCT02395042

Allergan59 enrolled

Overview

This is a safety and efficacy study of LiRIS® in females with interstitial cystitis with Hunner's lesions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystitis, Interstitial Ulcer

Interventions

LiRIS®DRUG

LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.

LiRIS PlaceboDRUG

LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Tri Valley Urology Medical Group

Murrieta, California, United States

Sutter Institute for Medical Research

Outcomes

Primary Outcomes

Change From Baseline in the Daily Average Bladder Pain Numeric Rating Scale (NRS)

The participant recorded their daily bladder pain score over the previous 24-hour period on a 7-day pain assessment tool as measured by an NRS on an 11-point scale where 0=no pain to 10=worst pain imaginable. The daily pain scores over the 7-day period were averaged. A negative change from Baseline indicates improvement. An analysis of covariance (ANCOVA) model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.

Time frame: Baseline (Day -7 to Day 0) to Week 4

Secondary Outcomes

Change From Baseline in the Number of Hunner's Lesions

During each cystoscopy, the investigator counted the number of lesions visible while performing the bladder scan. A negative change from Baseline indicates improvement (less lesions). An ANCOVA model with Baseline value as a covariate and treatment group and stratification (baseline bladder pain NRS: ≤ 5 or \> 5) as factors was used for analysis.

Time frame: Baseline (Day 0) to Week 4

Change From Baseline in Composite Score of Hunner's Lesions Calculated Based on Number, Size, and Severity of Lesions

A standardized video capture protocol for bladder mapping was followed to assess any changes in the number, the size and the severity, of lesions during the study as a result of treatment. A negative change from Baseline indicates improvement.

Time frame: Baseline (Day 1) to Week 4

Data from ClinicalTrials.gov

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