Efficacy and safety of intradetrusor abobotulinumtoxinA and incobotulinumtoxinA in women with overactive bladder and the value of local anesthesia: a randomized clinical study.

Abstract

Background: A non-inferiority clinical study evaluated the efficacy and safety of abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections in women with overactive bladder and urge urinary incontinence. Also, the effect of local anesthesia on the pain level of the procedure was assessed.

Methods: Patients were randomized to receive 20 intradetrusor injections of either 300 U abobotulinumtoxinA or 100 U incobotulinumtoxinA. They were further randomized to receive either local anesthesia (40 ml 1% lidocaine solution) or placebo before botulinum toxin injection. Before the procedure and 4 months after the procedure each patient reported urinary incontinence episodes, frequency, nocturia, completed the Urogenital Distress Inventory (UDI-6) score, Incontinence Impact Questionnaire (IIQ-7), and Incontinence Quality of Life (I-QOL) questionnaire. Each patient completed a patient satisfaction survey 4 months after the procedure. During the procedure, the patients graded the pain intensity of every injection on a visual analog scale (VAS). The total score of each questionnaire was considered.

Results: A total of 54 patients with a mean age of 66 ± 13 (SD) years completed the study. Total scores of UDI‑6, IIQ‑7, I‑QOL, patient satisfaction, urinary incontinence episodes, frequency, nocturia and VAS questionnaires did not show differences between the abobotulinumtoxinA (n = 26) or incobotulinumtoxinA (n = 28) group. Urinary retention requiring catheterization was noted in five patients. The VAS and patient satisfaction questionnaire values did not show significant differences between the group receiving bladder instillation with lidocaine solution (n = 28) or the group receiving placebo (n = 26).

Conclusion: In women with overactive bladder and urge urinary incontinence where conservative treatment failed, abobotulinumtoxinA vs. incobotulinumtoxinA intradetrusor injections showed comparable results regarding improved clinical outcome and patient satisfaction. Local anesthesia before the procedure did not reduce the pain level in comparison with the placebo.