The following is a summary of “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,” published in the AUGUST 2023 issue of Urology by Raisin, et al.
Intravesical instillation, or the direct delivery of drugs into the bladder, has effectively treated pain and voiding symptoms associated with various bladder conditions. However, one limitation of the approach is the loss of drugs through urination and their dilution within the bladder, which can reduce treatment durability and clinical benefits. A sustained delivery system called TRG-100, designed to extend the exposure of the urinary bladder to analgesic and anticholinergic drugs (a fixed-dose combination of lidocaine and oxybutynin), has been developed and tested in vitro. For a study, researchers sought to assess the safety and efficacy of TRG-100 in patients with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS), overactive bladder (OAB), and those who have undergone endourological intervention with stent placement (EUI), in an open-label, prospective study.
A total of 36 patients were enrolled, including 10 with IC/BPS, 10 with OAB, and 16 with EUI. EUI patients received a once-weekly installation of TRG-100 until their stents were removed, while OAB and IC/BPS patients received weekly installations for four consecutive weeks. Treatment effectiveness was evaluated using various measures, including visual analog scale (VAS) scores for the EUI group, voiding diaries for the OAB group, and VAS scores, voiding diaries, and O’Leary-Sant Questionnaires for the IC/BPS group.
In the EUI group, patients experienced an average 4-point improvement in their VAS scores. The OAB group showed a significant 33.54% reduction in urinary frequency, and the IC/BPS group exhibited a mean 3.2-point improvement in their VAS scores, a 25.43% reduction in urinary frequency, and an average 8.1-point decrease in O’Leary-Sant Questionnaires scores. All these changes were statistically significant.
Intravesical instillation of TRG-100 was safe and effective in reducing pain and irritative bladder symptoms in the study population. The efficacy and safety of TRG-100 should be further evaluated in a larger, randomized controlled trial.