Results of a Prospective, Multicenter Study Evaluating Quality of Life, Safety, and Efficacy of Sacral Neuromodulation at Twelve Months in Subjects With Symptoms of Overactive Bladder
"This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications."
Noblett K, Siegel S, Mangel J, et al. Neurourol Urodyn. 2014. doi:10.1002/nau.22707
Results of a Prospective, Randomized, Multicenter Study Evaluating Sacral Neuromodulation with InterStim Therapy Compared to Standard Medical Therapy at 6-Months in Subjects with Mild Symptoms of Overactive Bladder
"This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms."
Siegel S, Noblett K, Mangel J, et al. Neurourol Urodyn. 2014 Jan 10. doi: 10.1002/nau.22544
"This article summarizes the epidemiology and symptomatology, office evaluation, and treatment of overactive bladder with particular emphasis on sacral nerve stimulation (SNS). SNS technique, results, and future applications are also reviewed."
Kohli N, Patterson D. Rev Obstet Gynecol. 2009;2(1):18-27.
Results of Sacral Neuromodulation Therapy for Urinary Voiding Dysfunction: Outcomes of a Prospective, Worldwide Clinical Study
"This long-term study demonstrates that InterStim® Therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment."
van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, et al. Journal of Urology. 2007;178:2029-2034.
"Oral anticholinergic therapy and onabotulinumtoxinA by injection were associated with similar reductions in the frequency of daily episodes of urgency urinary incontinence. The group receiving onabotulinumtoxinA was less likely to have dry mouth and more likely to have complete resolution of urgency urinary incontinence but had higher rates of transient urinary retention and urinary tract infections."
Visco AG, Brubaker L, et al. N Engl J Med. 2012 Nov 8;367(19):1803-13.
Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results from the Overactive Bladder Innovative Therapy Trial
"This multicenter, randomized trial demonstrates that percutaneous tibial nerve stimulation is safe with statistically significant improvements in patient assessment of overactive bladder symptoms, and with objective effectiveness comparable to that of pharmacotherapy. Percutaneous tibial nerve stimulation may be considered a clinically significant alternative therapy for overactive bladder."
Peters KM, Macdiarmid SA, et al. J Urol. 2009 Sep;182(3):1055-61
"Our objective was to evaluate the burden of sacral neuromodulation (SNM) reprogramming and the reasons for reprogramming, and to correlate these with the underlying diagnosis. . . . There was no correlation with number of reprogramming events and patient age, sex, reason for implantation, or diagnosis. These data suggest that the number of reprogramming episodes is small, and the majority is done as part of routine follow-up."
Burks FN, Ananais C, Lajiness MJ, et al. International Urogynecology Journal. 2008;19(8):1137-1140.
In patients undergoing neuromodulation for intractable urge incontinence a reduction in 24-hr pad weight after the initial test stimulation best predicts long-term patient satisfaction
"To evaluate long-term patient satisfaction of sacral neuromodulation and to correlate satisfaction with incontinence parameters. . . . Eighty-four percent of patients were satisfied with sacral neuromodulation at a mean of 27 months. An 84.5% reduction in 24-hr pad weight correlated with long-term patient satisfaction. In addition to lack of efficacy, device pain was a contributing factor to dissatisfaction."
Foster RT Sr., Anoia EJ, Webser GD, Amundsen CL. Neurourol Urodyn. 2007;26(2):213-217.
"The objective of this study was to determine the variables that affect the cure rate in patients with urge incontinence treated with sacral neuromodulation."
Amundsen CL, Romero AA, Jamison MG, Webster GD. Urology. 2005 Oct;66(4): 746–750.
"The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed...The therapeutic effect and improved quality of life for fecal incontinence is maintained 5
years after sacral nerve stimulation implantation and
Hull T, Giese C., Wexner SD, Mellgren A., et al. Dis Colon Rectum. 2013 Feb;56(2):234-45.
Sacral Nerve Stimulation Is More Effective Than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study
"Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation or best supportive therapy, which consisted of pelvic floor exercises, bulking agent, and dietary manipulation....In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group."
Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Dis Colon Rectum. 2008 May;51(5):494-502.
"Our data demonstrate that SNS significantly improves patients' QOL, including their physical and psychological well-being."
Hetzer FH, Hahnloser D, Clavien PA, Demartinex N. Arch Surg. 2007
Efficacy of Sacral Nerve Stimulation for Fecal Incontinence: Results of a Multicenter Double-blind Crossover Study
"This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients....The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo."
Leroi AM, Parc Y, Lehur PA, et al. Annals of Surgery, 2005