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.

Serial retrograde instillations of sustained release formulation of mitomycin C to the upper urinary tract of the Yorkshire swine using a thermosensitive polymer: Safety and feasibility.

Background: MitoGel is a novel drug formulation intended for the treatment of upper tract urothelial cancer with proven feasibility and safety in an animal model.

Objective: To evaluate the feasibility, safety, toxicokinetics, and histologic changes associated with serial retrograde MitoGel instillations to the upper urinary tract in a swine model.

Design, Setting, And Participants: Overall, 27 Yorkshire swine underwent 6 once-weekly unilateral retrograde instillations of MitoGel.

Sustained-release Formulation of Mitomycin C to the Upper Urinary Tract Using a Thermosensitive Polymer: A Preclinical Study.

Objective: To evaluate the safety and feasibility of single and serial instillations of MitoGel into the upper urinary tract using a preclinical swine animal model. MitoGel is a novel sustained release formulation of mitomycin C (MMC) based on RTGel, a proprietary thermosensitive hydrogel technology. MitoGel is liquid at cold temperatures and solidifies to gel state at body temperature.