A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions

Allergan10 enrolled

Overview

The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any change in the bladder or in IC symptoms, following LiRIS administration.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Interstitial Cystitis

Interventions

LiRIS® 400 mgDRUG

LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women age 18 and older * Interstitial Cystitis with history of Hunner's lesions in the bladder * Moderate to severe bladder discomfort * Confirmation of Hunner's lesions in Bladder * Able to report symptom (pain and voiding frequency) in a diary throughout the study Exclusion Criteria: * Pregnant women * History or presence of bladder cancer * History or presence of any condition that would make it difficult to evaluate bladder symptoms

Locations (2)

Advance Urology Institute

Daytona Beach, Florida, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

Outcomes

Primary Outcomes

Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 14

The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR)=presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either: i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.

Time frame: Baseline, Day 14

Percentage of Participants by Change From Baseline in Appearance of Hunner's Lesions at Day 28

The appearance of the Hunner's lesions was assessed by the investigator using video capture of the bladder mucosa during the cystoscopic examinations. Complete responders (CR)=no lesions observed at day of last LiRIS removal; Partial responders (PR) = presence of residual lesions on day of last LiRIS removal however there is cystoscopic evidence of a decrease in either i) the affected area as calculated by size and dimension of individual lesions summed together or ii) the lesion number or iii) the lesion(s) severity (mild, moderate, severe) as compared with Baseline assessment; Stable Disease=no change in the appearance of lesions and no new lesions on day of last LiRIS removal compared with Baseline assessment; Non-responders=worsening of mucosal appearance on day of last LiRIS removal.

Time frame: Baseline, Day 28

Secondary Outcomes

Change From Baseline in Patient Reported Interstitial Cystitis (IC) Symptom: Average Bladder Pain

Participants rated symptom bladder pain averaged over the previous 3 days using an 11-point numeric rating scale where: 0=no pain to 10=worst pain imaginable. A negative change from Baseline indicates improvement.

Data from ClinicalTrials.gov

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