Open Label, Pilot Evaluation of the Safety and Efficacy of Intravesical Sustained Release System of Lidocaine and Oxybutynin (TRG-100) for Patients With Interstitial Cystitis/Bladder Pain Syndrome, Overactive Bladder and Patients With Retained Ureteral Stents Following Endourological Interventions.

Background: Intravesical instillation of analgesic and anticholinergic drugs have shown efficacy in the treatment of pain and voiding symptoms. Unfortunately, drug loss with urination and dilution in the bladder limit their durability and clinical usefulness. We have recently developed and tested in vitro, a sustained delivery system (TRG-100) of fixed-dose combination of lidocaine and oxybutynin designed to allow for a longer exposure of the urinary bladder to the drugs.

Intravesical sustained release system of lidocaine and oxybutynin results from in vitro and animal study.

Purpose: Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic debilitating condition of unknown etiology. Intravesical lidocaine demonstrated pain relief in patients with IC/BPS. Intravesical oxybutynin has shown therapeutic efficacy in patients with urinary bladder disorders.

Interspecies differences in reaction to a biodegradable subcutaneous tissue filler: severe inflammatory granulomatous reaction in the Sinclair minipig.

Soft tissue filler products have become very popular in recent years, with ever-increasing medical and aesthetic indications. While generally considered safe, the number of reported complications with tissue fillers is growing. Nevertheless, there is no specific animal model that is considered as the gold standard for assessing safety or efficacy of tissue fillers, and there are very little data on interspecies differences in reaction to these products.