Pd54-06 a Prospective Randomized Clinical Trial Comparing Two Doses of Abobotulinumtoxina for Idiophatic Overactive Bladder

Abstract

Assessment (GRA), Interstitial Cystitis Symptom/Problem Index (ICSIPI) and Overactive Bladder symptom severity (OABq ss)/health related quality of life (HRQOL) collected at baseline, 3 and 6 months, and 1 and 2 years were analyzed with descriptive statistics and repeated measures over 1 year.RESULTS: Of 87 that had a lead placed, 72 (83%) had generator implantation and 65 had complete baseline data. 37/65 had a pudendal (12/37 had failed sacral stimulation) and 28 had a sacral lead. Group characteristics were similar except for pudendal had lower body mass index (median 24.8 vs. 28.6; p¼0.009) and fewer with primary urinary urgency/frequency (8.1% vs. 39.3%; p¼0.003). Pudendal patients more commonly had a primary diagnosis of pelvic pain that approached but was not statistically significantly (62.2% vs. 38.5%; p¼0.06). Median follow up was 1.2 vs. 2.6 years in the pudendal and sacral groups respectively (p¼0.0011). Median pelvic pain scores were similar between pudendal and sacral groups at baseline and each follow up, and both improved significantly over 1 year (p¼0.0003 and p<0.0001). The pudendal group had lower ISCIPI and OABq/ss scores at baseline (p¼0.007 and p¼0.035, respectively), but both groups improved over 1 year on the ICSIPI (p<0.0001 for both groups), OABq/ ss (p¼0.005 and p¼0.0002 respectively), and OABq HRQOL (p¼0.027 and p<0.0001, respectively). Similar proportions in the pudendal and sacral groups had pain at each follow up except for at 6 months (17/19; 90% vs. 8/14; 57%; p¼0.047); for those with pain, similar proportions (between 33% and 50%) had moderate/marked improved in pain on the GRA at each time point.CONCLUSIONS: Both groups experienced modest but similar improvements in pelvic pain. Pudendal was effective in those who failed sacral neuromodulation and was used preferentially in patients with a primary diagnosis of pain. Neuromodulation should be considered in the management of chronic pelvic pain.