Abstract: PD01-01
Sources of Funding: Allergan

Introduction

Pain relief is the key corner of Bladder Pain Syndrome/Interstitial cystitis (BPS/IC) management. The present prospective, randomized, double-blind, placebo-controlled (saline) clinical trial aims to evaluate the analgesic efficacy and safety of intra-trigonal injection of OnaBotA in patients with BPS/IC refractory to common treatment. _x000D_ _x000D_

Methods

Nineteen women with a pain score more than 4 in a 0-10 visual analogue scale (VAS) were enrolled. Patients were randomized to receive 100 Units (U) in 10 ml of saline (n=10) of OnaBotA (Botox) or the equivalent volume of saline (n=9) in 10 points of the bladder trigone under cystoscopic guidance and general anaesthesia. The primary outcome was VAS at 12 weeks (w). Secondary outcomes included VAS at 4 and 8w, day and night time frequency in a 3-day bladder diary, O’Leary-Sant score (OSS) and QoL 4, 8 and 12w after treatment. Treatment Benefit Scale (TBS) was evaluated at 12w. Side effects were registered, in particular post-void residual volumes (PVR) and urinary tract infections (UTIs)._x000D_ Results are presented as mean values ± standard deviation. T-test was used to compare the 2 arms at each time point._x000D_

Results

Mean age was identical (OnaBotA: 44±10y vs Saline: 48±11y). According to ESSIC classification each arm had 3 cases with Hunner lesions. At baseline the two groups were balanced for all clinical variables (table 1). _x000D_ At 12w VAS for pain was significantly lower in OnaBotA arm (3.1±2.8 versus 5±2.2, p<0.05). VAS was numerically lower in OnaBotA arm also at 4 and 8w (table 1). OSS, and QoL were significantly better in the OnabotA arm at 8 and 12w (table 1). Urinary frequency was numerically lower in OnaBotA arm (table 1). Treatment Benefit Scale was 1.9±0.9 in the OnabotA group versus 3.1±0.8 in the Saline group (p<0.05). _x000D_ Five UTIs occurred, 2 in Saline and 3 in the OnaBotA arms. No cases of voiding dysfunction were observed. _x000D_

Conclusions

This RCT demonstrates that intra-trigonal injection of 100U of OnaBotA is significantly better than placebo to reduce pain and to improve QoL in patients with refractory BPS/IC. Adverse events associated with intra-trigonal injection of 100U of OnaBotA were mild. No cases of urinary retention occurred._x000D_

Funding

Allergan