To evaluate therapeutic success rate, changes in quality of life (QOL) and safety with sacral neuromodulation (SNM) at 5 years after InterStim™ implant. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) and/or urgency-frequency (UF), who had failed at least 1 anticholinergic medication and had at least 1 medication untried were included.
Therapeutic success was defined as a UI or UF response: ≥ 50% improvement in average leaks or voids/day or a return to normal voiding (<8 voids/day). QOL was evaluated using the International Consultation on Incontinence Modular Questionnaire (ICIQ-OABqol). Safety was evaluated through adverse events (AE).
Of the 340 subjects who completed test stimulation, 272 were implanted; 91% were female and mean age was 57 years. At baseline, UI subjects had 3.1±2.7 leaks/day (n=202); UF subjects had 12.6±4.5 voids/day (n=189). The 5 year therapeutic success rate was 67% (95% CI: 60%-74%) using the modified completers analysis and 82% (95% CI: 76-88%) using the completers analysis. UI subjects had a mean reduction from baseline of 2.0 ± 2.2 leaks/day; UF subjects had a mean reduction of 5.4 ± 4.3 voids/day (both p<0.0001, completers analysis). Subjects showed improvement in all measures of ICIQ-OABqol (p<0.0001). The most common device-related AEs were undesirable change in stimulation (60/272, 22%), implant site pain (40/272, 15%), and therapeutic product ineffective (36/272, 13%).
This multicenter study shows that SNM has sustained efficacy and QOL improvements and an acceptable safety profile through 5 years in OAB subjects.
The Journal of urology. 2017 Jul 11 [Epub ahead of print]
Steven Siegel, Karen Noblett, Jeffrey Mangel, Jason Bennett, Tomas L Griebling, Suzette E Sutherland, Erin T Bird, Craig Comiter, Daniel Culkin, Samuel Zylstra, Fangyu Kan, Kellie Chase Berg
Metro Urology, Woodbury, MN. Electronic address: ., University of California, Riverside, CA., MetroHealth Medical Center, Cleveland, OH., Female Pelvic Medicine, Grand Rapids, MI., University of Kansas, Kansas City, KS., University of Washington, Seattle, WA., Scott and White Healthcare, Temple, TX., Stanford University, Stanford, CA., University of Oklahoma HSC, Oklahoma City, OK., Milford Regional Medical Center, Whitinsville, MA., Medtronic, Minneapolis, MN.