Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: A Multicenter Randomized Clinical Trial.

IMPORTANCE

Intradetrusor injection of onabotulinumtoxinA is performed via varying injection paradigms but no studies have studied the various effects of these paradigms on patient experience with the procedure.

OBJECTIVES

This randomized clinical trial aims to compare pain and procedure time between patients receiving a 100-unit dose of onabotulinumtoxinA in 5 injections compared to 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence.

STUDY DESIGN

Patients presenting with refractory overactive bladder or urgency urinary incontinence at 2 clinical sites were identified and randomized to undergo onabotulinumtoxinA treatment with 5 injections versus 20 injections. Patients rated their pain level on a 10-point visual analog scale at procedure completion. The procedure duration was recorded with a stopwatch. Patients were followed up 6 weeks postprocedure, at which time they completed a Global Response Assessment to determine subjective efficacy of treatment. Participants were additionally monitored for incidence of adverse events in the follow-up period.

RESULTS

The average pain score was not statistically significant between groups (2; interquartile range, 1-4 for the 5 injection group vs 3; interquartile range, 2-4 for the 20 injection group; P = 0.27). Patients who received 5 injections experienced significantly shorter mean procedure time as compared with patients who received 20 injections (76 seconds vs 176 seconds; P < 0.001). There were no differences in subjective efficacy or adverse events between groups.

CONCLUSIONS

Perceived pain, efficacy, and postprocedure complications did not significantly differ between patients receiving 5 injections and 20 injections, but procedure time was significantly shorter.