Steven Siegel1, Karen Noblett2, Jeffrey Mangel3, Tomas L Griebling4, Suzette E Sutherland5, Erin T Bird6, Craig Comiter7, Daniel Culkin8, Jason Bennett9, Samuel Zylstra10, Fangyu Kan11, Elizabeth Thiery11. 1. Metro Urology, Woodbury, MN. Electronic address: siegel.steven@gmail.com. 2. University of California, Riverside, CA. 3. MetroHealth Medical Center, Cleveland, OH. 4. University of Kansas, Kansas City, KS. 5. University of Washington, Seattle, WA. 6. Scott and White Healthcare, Temple, TX. 7. Stanford University, Stanford, CA. 8. University of Oklahoma HSC, Oklahoma City, OK. 9. Female Pelvic Medicine, Grand Rapids, MI. 10. Milford Regional Medical Center, Whitinsville, MA. 11. Medtronic, Inc., Minneapolis, MN.
Abstract
OBJECTIVE: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. 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 untried medication were included. METHODS: Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS: A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION: The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.
OBJECTIVE: To evaluate the therapeutic success rate, and changes in quality of life (QOL) and safety in subjects using sacral neuromodulation (InterStim System) at 36 months. 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 untried medication were included. METHODS: Subjects with successful test stimulation received an InterStim implant. Therapeutic success and quality of life through 36 months was evaluated in implanted subjects with data at baseline and follow-up. Safety was evaluated using reported adverse events. RESULTS: A total of 340 subjects received test stimulation resulting in 272 implanted subjects. Demographics include 91% female, mean age of 57 years, and baseline symptom severity of 3.1 ± 2.7 leaks/day (UI) and 12.6 ± 4.5 voids/day (UF). The analysis showed an OAB therapeutic success rate of 83% (95% confidence interval: 78%-88%). UI subjects had a mean reduction from baseline of 2.3 ± 2.3 leaks/day whereas UF subjects had a mean reduction of 5.3 ± 4.0 voids/day (both P < .0001). Statistically significant improvements were observed in all measures of the International Consultation on Incontinence Modular Questionnaire-OABqol (all P < .0001). Eighty percent of subjects reported improvements in their urinary symptom interference. Device-related adverse events occurred in 47% (127/272) of subjects post-implant; 91% were resolved at the time of this analysis. CONCLUSION: The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications.
Authors: Ethan M Balk; Gaelen P Adam; Katherine Corsi; Amanda Mogul; Thomas A Trikalinos; Peter C Jeppson Journal: J Gen Intern Med Date: 2019-05-06 Impact factor: 5.128
Authors: Cindy L Amundsen; Yuko M Komesu; Christopher Chermansky; W Thomas Gregory; Deborah L Myers; Emily F Honeycutt; Sandip P Vasavada; John N Nguyen; Tracey S Wilson; Heidi S Harvie; Dennis Wallace Journal: Eur Urol Date: 2018-02-24 Impact factor: 20.096
Authors: Pedro Simoes de Oliveira; José Palma Reis; Tiago Ribeiro de Oliveira; David Martinho; Ricardo Pereira E Silva; Joao Marcelino; Sandro Gaspar; Francisco Martins; Tome Lopes Journal: Curr Urol Date: 2019-07-20