TY - JOUR
T1 - 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
T2 - A Pilot Study
AU - Rappaport, Yishai H.
AU - Zisman, Amnon
AU - Jeshurun-Gutshtat, Michal
AU - Gerassi, Tami
AU - Hakim, Gil
AU - Vinshtok, Yuri
AU - Stav, Kobi
N1 - Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/4
Y1 - 2018/4
N2 - Objective: To 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. Methods: A 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. Results: A 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. Conclusion: Intravesical instillation of a TC-3 gel-BTX-A mixture is safe and tolerable. Preliminary results suggest temporary efficacy lasting for a few weeks.
AB - Objective: To 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. Methods: A 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. Results: A 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. Conclusion: Intravesical instillation of a TC-3 gel-BTX-A mixture is safe and tolerable. Preliminary results suggest temporary efficacy lasting for a few weeks.
UR - http://www.scopus.com/inward/record.url?scp=85044343181&partnerID=8YFLogxK
U2 - 10.1016/j.urology.2017.12.028
DO - 10.1016/j.urology.2017.12.028
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C2 - 29307733
AN - SCOPUS:85044343181
SN - 0090-4295
VL - 114
SP - 60
EP - 65
JO - Urology
JF - Urology
ER -