Safety and Feasibility of Intravesical Instillation of Botulinum Toxin-A in Hydrogel-based Slow-release Delivery System in Patients With Interstitial Cystitis-Bladder Pain Syndrome: A Pilot Study

摘要

ObjectiveTo assess the feasibility and the safety of a mixture instillation of TC-3 gel, a novel reverse-thermal gelation hydrogel, and botulinum toxin-A (BTX-A) for the treatment of interstitial cystitis-bladder pain syndrome (IC/BPS). TC-3 gel-BTX-A mix is instilled into the bladder as liquid, solidifies because of body heat, and gradually dissolves to release BTX-A for several hours. MethodsA single intravesical instillation of 200?U BTX-A premixed with 40?mL TC-3 gel was delivered to the bladder. Adverse events and preliminary efficacy outcome measures were assessed: bladder diary, visual analog scale (VAS) for pain, and Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI) at baseline and at 2, 6, and 12 weeks. ResultsA total of 15 severely symptomatic patients with IC/BPS (ICSI and ICPI score ranges 12-19 and 12-16, respectively; median VAS?=?7) were enrolled (male and female?=?4 and 11, ages 24-76). In terms of safety, no increase in VAS score was noted at instillation. All adverse events were transient and mild, the most common being temporary mild constipation (n?=?4, 26%). The mean VAS at baseline vs week 12 was 6.6?±?2.7 vs 5.3?±?2.8 (P?=?.044). The mean ICSI and ICPI scores were reduced at week 12 compared with baseline (15.4?±?2.4 vs 12.9?±?4.3,P?=?.004, and 14.8?±?1.4 vs 11.9?±?4.0,P?=?.004, respectively). The mean number of voids per night at baseline decreased for 6 weeks (3.3?±?2.1 vs 1.8?±?0.9,P?=?.046) and then returned to baseline level at week 12. ConclusionIntravesical instillation of a TC-3 gel-BTX-A mixture is safe and tolerable. Preliminary results suggest temporary efficacy lasting for a few weeks.