Intratrigonal OnabotulinumtoxinA Improves Bladder Symptoms and Quality of Life in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Pilot, Single Center, Randomized, Double-Blind, Placebo Controlled Trial

8Citations
Citations of this article
22Readers
Mendeley users who have this article in their library.

Abstract

Purpose: We compared the efficacy and safety of trigonal injections of onabotulinumtoxinA and saline in patients with bladder pain syndrome/interstitial cystitis. Materials and Methods: This phase II study enrolled women who had had bladder pain syndrome/interstitial cystitis for more than 6 months and pain for 4 months or longer on a visual analogue scale of 0 to 10, which were refractory to common treatment. OnabotulinumtoxinA 100 U in 10 or saline as placebo in 9 was administered as 10 trigonal injections of 1 ml. The primary study end point was the change from baseline pain intensity reported at week 12. Additional end points included O'Leary-Sant scores, micturition frequency, quality of life at week 4, 8 and 12, and the treatment benefit scale at week 12. Safety assessments included urinary tract infection, post-void residual urine and the initiation of clean intermittent catheterization. Results: At week 12 onabotulinumtoxinA had significantly reduced pain compared with saline (mean ± SD –3.8 ± 2.5 vs –1.6 ± 2.1, p <0.05). The proportion of patients who achieved a 50% or greater reduction in the pain visual analog scale was 60% for onabotulinumtoxinA vs 22% for placebo. OnabotulinumtoxinA significantly improved O'Leary-Sant scores and quality of life over placebo at weeks 4, 8 and 12. Important numerical reductions in voiding frequency were also observed with the toxin. OnabotulinumtoxinA was well tolerated. Urinary tract infections developed in 3 patients who received onabotulinumtoxinA vs 2 who received saline. Mean post-void residual urine at week 12 was 5 ± 13 ml for onabotulinumtoxinA vs 0 ml with saline. This study had the limitations inherent to a single center trial with a small number of patients enrolled. Conclusions: OnabotulinumtoxinA 100 U caused significant and clinically relevant improvements in bladder pain and quality of life in patients with bladder pain syndrome/interstitial cystitis refractory to common therapy. It was also well tolerated.

Cite

CITATION STYLE

APA

Pinto, R. A., Costa, D., Morgado, A., Pereira, P., Charrua, A., Silva, J., & Cruz, F. (2018). Intratrigonal OnabotulinumtoxinA Improves Bladder Symptoms and Quality of Life in Patients with Bladder Pain Syndrome/Interstitial Cystitis: A Pilot, Single Center, Randomized, Double-Blind, Placebo Controlled Trial. Journal of Urology, 199(4), 998–1003. https://doi.org/10.1016/j.juro.2017.10.018

Register to see more suggestions

Mendeley helps you to discover research relevant for your work.

Already have an account?

Save time finding and organizing research with Mendeley

Sign up for free