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.

Objective: To asses the safety and efficacy of TRG-100 in Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), overactive bladder (OAB), and endourological intervention stented (EUI) patients in an open-label, prospective study.

Methods: Thirty-six patients were enrolled: 10 IC/BPS, 10 OAB, and 16 EUI. EUI patients received a once-weekly installation until stent removal, OAB and IC/BPS patient received weekly installations for 4 consecutive weeks. Treatment effect was assessed by visual analog scale (VAS) score for the EUI group, voiding diaries for OAB group and VAS score, voiding diaries and O'Leary Sant Questionnaires for the IC/BPS group.

Results: The EUI group showed a mean 4-point improvement in their VAS score. The OAB group showed 33.54% reduction in frequency of urination and IC/PBS group showed a mean of 3.2-point improvement in their VAS score, 25.43% reduction in frequency of urination, and a mean 8.1-point reduction in O'Leary Sant Questionnaires score. All changes were statistically significant.

Conclusion: Intravesical instillation of TRG-100 was found to be safe and efficient in reducing pain and irritative bladder symptoms in our study population. TRG-100 efficacy and safety should be further assessed in a large, randomized control trial.