Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

Purpose: We evaluated the therapeutic success rate, changes in quality of life and safety of sacral neuromodulation 5 years after InterStim (TM) implantation. Included in study were subjects with bothersome symptoms of overactive bladder, including urinary urge incontinence and/or urgency-frequency, in whom at least 1 anticholinergic medication failed and 1 medication had not been tried. Materials and Methods: Therapeutic success was defined as a urinary urge incontinence or urgency-frequency response of 50% or greater improvement in average leaks or voids per day, or return to normal voiding, defined as fewer than 8 voids per day. Quality of life was evaluated by ICIQ-OABqol (International Consultation on Incontinence Modular Questionnaire). Safety was evaluated through adverse events. Results: Of the 340 subjects who completed the test stimulation 272 had an implant, of whom 91% were female. Mean age was 57 years. At baseline 202 subjects with urinary urge incontinence had a mean +/- SD of 3.1 +/- 2.7 leaks per day and 189 with urgency-frequency had a mean of 12.6 +/- 4.5 voids per day. The 5-year therapeutic success rate was 67% ( 95% CI 60-74) using modified completers analysis and 82% (95% CI 76-88) using completers analysis. Subjects with urinary urge incontinence had a mean reduction from baseline of 2.0 +/- 2.2 leaks per day and subjects with urgency-frequency had a mean reduction of 5.4 +/- 4.3 voids per day (each completers analysis p < 0.0001). Subjects showed improvement in all ICIQ-OABqol measures (p < 0.0001). The most common device related adverse events were an undesirable change in stimulation in 60 of the 272 subjects (22%), implant site pain in 40 (15%) and therapeutic product ineffectiveness in 36 (13%). Conclusions: This multicenter study shows that sacral neuromodulation had sustained efficacy and quality of life improvements, and an acceptable safety profile through 5 years in subjects with overactive bladder.