Introduction: Botulinum toxin A (BTX-A) is currently used as a fourth-line therapeutic option for interstitial cystitis/bladder pain syndrome (IC/BPS) management. The purpose of this study was to determine if BTX-A injection can mitigate pain and if injection location (i.e. trigone-including versus trigone-sparing injection template) impacts treatment efficacy and/or treatment complications profile.
Materials and methods: Female IC/BPS patients refractory to conservative management strategies were prospectively enrolled and asked to complete a baseline history and physical exam, post-void residual (PVR) urine volume determination, O'Leary Sant (OLS) questionnaire, and Pelvic Pain and Urgency/Frequency Symptom Scale (PUF) questionnaire. Participants were randomly assigned to one of two treatment groups and received either: 1) a trigone-including BTX-A injection template or 2) a trigone-sparing injection template. Following therapy, patients were examined in clinic at 30 and 90 day post-treatment with symptom re-assessment via repeat questionnaires and for evidence of post-procedural complications.
Results: Compared to baseline, patients in both treatment groups experienced significant improvement in OLS and PUF scores at both 30 and 90 days post-treatment with BTX-A, regardless of which injection template was used (p < 0.05). Complications resulting from BTX-A were minimal (most commonly urinary tract infection (UTI) and urinary retention) and not significantly different between the treatment groups (p > 0.05). No distant spread of BTX-A was observed in any patient in either treatment group.
Conclusions: BTX-A treatment using either a trigone-sparing or trigone-including injection template resulted in significant, but not location-dependent, improvement in IC/BPS symptom scores at 30 and 90 day points post-procedure with no significant difference in post-treatment complication profiles.