Double-Blind Placebo Controlled Study of Safety,Tolerability, and Efficacy of LiRIS® in Women With Interstitial Cystitis

The study is conducted in 2 parts - a randomized, blinded part in which patients are
randomly assigned to one of 3 possible arms (LiRIS® - contains lidocaine), LiRIS Placebo
(LiRIS with inactive substance) or Sham(Insertion procedure only with neither LiRIS nor
LiRIS Placebo), followed by an open extension part in which all patients are assigned to
receive LiRIS® (with lidocaine). In part 1 of the study, treatment is managed in a
double-blind manner for LiRIS® and LiRIS Placebo arms; and in a single-blind manner for the
Sham arm (e.g.,the study doctor will know the treatment assignment for patients assigned to
Sham).

All patients who complete part 1 of the study have the option to enter the extension.

Inclusion Criteria:

- Women age 18 and over

- Diagnosed with Interstitial Cystitis as defined by protocol

- Able and willing to complete questionnaires and diary

- Able to comply with visit schedule including Day 14 Removal visit

- Completion of blinded study prior to enrolling in unblinded part of study

Exclusion Criteria:

- Pregnant or lactating women

- Bladder or urethra anatomical feature that would prevent the safe indwelling or
insertion of the investigational product

- History or presence of any condition that would make it difficult to evaluate
symptoms

- Did not complete blinded study (unblinded part of study only)