PD27-07 EVALUATION OF QUALITY OF LIFE IMPROVEMENTS AT 36 MONTHS IN SUBJECTS WITH OVERACTIVE BLADDER TREATED WITH SACRAL NEUROMODULATION USING THE INTERSTIM® SYSTEM

Abstract

INTRODUCTION AND OBJECTIVES: Changes in quality of life (QOL) at 36 months for subjects treated with sacral neuromodulation (SNM) using the InterStim System were assessed as part of the InSite study, a prospective, multicenter, post-approval study. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least 1, but not all, anticholinergic medications were included. METHODS: Subjects with successful test stimulation received an SNM implant. QOL from baseline through 36 months was evaluated for all implanted subjects using the validated disease-specific International Consultation on Incontinence Modular Questionnaire (ICIQOABqol) and Female/Male Lower Urinary Tract Symptom sexual function (FLUTSsex and MLUTSsex), Beck Depression Inventory II (BDI-II) and Visual Analogue Scale (VAS) for Pelvic Pain associated with urgency instruments. RESULTS: Of the 340 subjects who completed test stimulation, 272 subjects were implanted; 91% were female and the mean age was 57 years. At baseline, UI subjects had a mean of 3.1 2.7 leaks/day; UF subjects had a mean of 12.6 4.5 voids/day. At 36 months, UI subjects had a mean reduction from baseline of 2.3 2.4 leaks/day; UF subjects had a mean reduction of 5.3 4.0 voids/day (both p<0.0001). Subjects showed statistically significant improvement from baseline to 36 months in all measures of ICIQ-OABqol (Concern, Coping, Sleep, Social, Health Related Quality Life total score, and Interference; all p<0.0001). Results from the Interference measure show that 80% of subjects had improvements in their urinary symptom interference. A reduction in the severity of depression (BDI-II) and pelvic pain (VAS) were demonstrated (both p<0.0001). Improvements in sexual function were found for female subjects (p<0.0001). Device-related adverse events occurred in 44% (121/272) of subjects post-implant (one event of implant site erosion was serious); 89% of these were resolved at the time of this analysis. CONCLUSIONS: This multicenter study shows that SNM results in improved quality of life through 36 months of follow-up when offered to subjects with OAB symptoms without requiring failure of all medications.