POST VOID RESIDUAL VOLUME AND RATES OF CLEAN INTERMITTENT CATHETERIZATION WITH SPONTANEOUS AND NON-SPONTANEOUS VOIDING AFTER ONABOTULINUMTOXINA TREATMENT

INTRODUCTION AND OBJECTIVE: OnabotulinumtoxinA (onabotA) is a well-tolerated, effective treatment for overactive bladder (OAB); transient increases in post void residual volume (PVR) have been reported following treatment with some cases requiring clean intermittent catheterization (CIC). Increases in PVR may be a driver for follow-up and CIC initiation in real-world practice. The rate of the complete inability to void has not previously been reported. This analysis evaluated maximum PVR (maxPVR) after onabotA 100U treatment, CIC use, and rates of spontaneous/non-spontaneous voiding. METHODS: This was a pooled post hoc analysis of two phase 3 studies. Patients were stratified based on maxPVR measured during the 12 weeks after initial onabotA 100U treatment into groups of 100 mL increments (0-100 mL, 101-200 mL, 201-300 mL, 301-400 mL, 401-500 mL, 501-600 mL, and ≥601 mL). Rates of clean intermittent catheterization (CIC) were assessed at each maxPVR category and rates of spontaneous and non-spontaneous voiding were calculated in patients who initiated CIC. Per phase 3 protocols, CIC was initiated if PVR was ≥200 to <350 mL with relevant associated symptoms assessed by the investigator, or if PVR was ≥350 mL regardless of symptoms. RESULTS: This analysis included 551 onabotA-treated patients. Most patients had a maxPVR ≤200 mL (494/551, 89.7%) and few patients had a maxPVR ≥201 mL (57/551, 10.3%). Most episodes of significantly raised PVR occurred within the first 6 weeks. In total, 36/551 (6.5%) patients receiving onabotA required CIC throughout the study and was highest in patients with maxPVR >300 mL (25/30, 83.3%) versus ≤300 mL (11/521, 2.1%). No consistent trend in mean CIC duration was observed across the maxPVR subgroups (39-106 days). Only one patient (0.2%) with a maxPVR in the ≥601 mL category was unable to spontaneously void (Figure). CONCLUSIONS: This analysis suggests the vast majority of onabotA-treated patients (99.8%) do not develop a complete inability to void; seen here in only one patient. All other patients that initiated CIC were able to spontaneously void and so did not meet the International Continence Society’s definition of urinary retention (inability to pass urine despite persistent effort).Source of Funding: Allergan plc.