Evaluation of Intravesical LP08 in Patients With Interstitial Cystitis/Painful Bladder Syndrome

Exclusion criteria

• . Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
• . Have received investigational products or devices within 30 days prior to screening visit
• . Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
• . Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
• . Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
• . Have indicated use of \> 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
• . Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
• . Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days