Use of Sacral Neuromodulation in the Management of ... - SUNA

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Clinical Results: 5-Year Efficacy Purpose This post-approval, non-randomized, multicenter study provided data on the longterm effects of sacral nerve stimulation for the treatment of urinary urge incontinence, urinary urgency-frequency, and urinary retention in patients who had failed or could not tolerate more conservative treatments. The study took place at 17 centers in the United States, Canada, and Europe. Results The study demonstrated that InterStim Therapy can be a long-term solution for patients with overactive bladder or non-obstructive urinary retention. Based on the subset of study subjects for whom both baseline and five-year data were available (i.e., the evaluable sample), improvement ranged from 39% to 78%, depending on the outcome assessed. If all implanted study subjects are considered (i.e., the intent-to-treat sample) and missing five-year data are imputed using baseline values (or, in the absence of baseline values, from the mean baseline of all subjects with baseline values), the results range from 28% to 58%, depending on the outcome assessed. See InterStim Therapy Clinical Summary for complete details.
5-Year Clinical Efficacy Urge Incontinence – 60 month post-implant results Patients % 80 70 60 50 40 30 20 10 0 Intent to Treat 37% 42% 59% ≥ 50% Reduction in Leaks/Day Evaluable Patients 71% n = 96 n = 84 n = 61 n = 49 ≥ 50% Reduction in Heavy Leaks/Day 1 1 Excludes patients who reported no heavy leaks at baseline and at 60 months post-implant Intent to Treat Patients – defined as all implanted study subjects, including those who dropped out and were imputed as no change from baseline. Evaluable Patients – defined as the subset of subjects for whom both baseline and 5- year data were available.
Page 1 and 2: Use of Sacral Neuromodulation in th
Page 3 and 4: Program Goal To discuss the prevale
Page 5 and 6: Voiding Dysfunction: A Hidden Probl
Page 7 and 8: Filling Phase • Automatic Actions
Page 9 and 10: Abnormal Micturition Voiding dysfun
Page 11 and 12: Overview Sacral Nerve Stimulation (
Page 13 and 14: SNS - Therapy SNS utilizes mild ele
Page 15: Pharmacotherapy vs. SNS Therapy Pha
Page 19 and 20: 5-Year Clinical Efficacy Urinary Re
Page 21 and 22: Treatment Algorithm For Urinary Urg
Page 23 and 24: Other Issues Influencing Patient Se
Page 25 and 26: Test & Implant Procedures • 1 st
Page 27 and 28: Voiding Diary Documentation 3 days
Page 29 and 30: 2 nd Stage Implant Procedure 2 nd S
Page 31 and 32: Benefits of SNS Potential Adverse E
Page 33 and 34: Case Studies Retention with frequen
Page 35 and 36: Voiding Diary • Pt voids 2-4 oz q
Page 37 and 38: Strains to Void
Page 39 and 40: Urodynamic Results • Normal stora
Page 41 and 42: Post InterStim Implant • Doing ex
Page 43 and 44: Utilization of Multiple Modalities
Page 45 and 46: Management of Care • Life choices
Page 47 and 48: Summary • SNS is an effective tre
Page 49 and 50: Revision for SUNA Oct 2010 - Lisa Z

Use of Sacral Neuromodulation in the Management of ... - SUNA

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