Comparative study of efficacy and safety between bladder body and trigonal intravesical onabotulinumtoxina injection in the treatment of interstitial cystitis refractory to conventional treatment-A prospective, randomized, clinical trial.

Abstract

Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). However, the therapeutic efficacy of different injection sites is not well known. This study compared therapeutic efficacy and safety between bladder body and trigonal BoNT-A injection. Patients were randomly treated with 100U of BoNT-A in 10 mL saline injected into 20 bladder body sites or 10 trigonal sites. The primary endpoint was changes of Visual Analog Scale (VAS) for Pain at 8th week after injection. Secondary endpoint included changes of Global Response Assessment (GRA), urinary frequency episodes, O'Leary-Sant score (OSS), and urodynamic study. Thirty-nine patients (bladder body, N = 20; trigone, N = 19) completed the study visits. Patients in both group had significant improvement in VAS, OSS, and functional bladder capacity after treatment. There was no significant difference in changes of urinary frequency, voided volume, post-void residual volume, and bladder capacity from baseline to 8 weeks between groups. Thirteen (65.0%) patients in bladder body group and 10 (52.6%) patients in trigone group had decrease of VAS more than 2 points after treatment (P = 0.43). Excellent symptom improvement (GRA ≥ 2) was noted in 9 (45%) patients with bladder body injection and 10 (52.6%) patients with trigonal injection (P = 0.63). Nine (45.0%) patients in bladder body group and 10 (52.6%) in trigonal group experienced dysuria after treatment (P = 0.52). No significant difference in the improvement of IC symptoms and urodynamic parameters after intravesical BoNT-A injection in the bladder body or trigone. The rate of adverse events was similar between groups.