The DOI matches its Crossref record; 20 of the 20 references it cites were found in a registry or an index.
Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial
Abstract
PURPOSE: The Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy. The improvement in global response assessment, voiding diary parameters, and overactive bladder and quality of life questionnaires was evaluated. MATERIALS AND METHODS: A total of 220 adults with overactive bladder symptoms were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder and quality of life questionnaires as well as 3-day voiding diaries were completed at baseline and at 13 weeks. Subject global response assessments were completed at week 13. RESULTS: The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p <0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported. CONCLUSIONS: This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.
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Cites
SF-36 health survey: Manual and interpretation guide
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Criterion validity and reliability of the SF-36 in a population sample
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Peters, K. M., MacDiarmid, S. A., Wooldridge, L. S., Leong, F. C., Shobeiri, S. A., Rovner, E. S., Siegel, S. W., Tate, S. B., Jarnagin, B. K., Rosenblatt, P. L., et al. (2009) · Journal of Urology · doi:10.1016/j.juro.2009.05.045 · Cited by 373
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MacDiarmid, S. A., Peters, K. M., Shobeiri, S. A., Wooldridge, L. S., Rovner, E. S., Leong, F. C., Siegel, S. W., Tate, S. B., & Feagins, B. A. (2010) · Journal of Urology · doi:10.1016/j.juro.2009.08.160 · Cited by 222
Self-citationPOSTERIOR TIBIAL NERVE STIMULATION AS NEUROMODULATIVE TREATMENT OF LOWER URINARY TRACT DYSFUNCTION
van BALKEN, M. R., VANDONINCK, V., GISOLF, K. W. H., VERGUNST, H., KIEMENEY, L. A. L. M., DEBRUYNE, F. M. J., & BEMELMANS, B. L. H. (2001) · Journal of Urology · doi:10.1016/s0022-5347(05)65863-6 · Cited by 214
Cited by
Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline
Gormley, E. A., Lightner, D. J., Burgio, K. L., Chai, T. C., Clemens, J. Q., Culkin, D. J., Das, A. K., Foster, H. E., Scarpero, H. M., Tessier, C. D., et al. (2012) · Journal of Urology · doi:10.1016/j.juro.2012.09.079 · Cited by 710
Lower urinary tract dysfunction in the neurological patient: clinical assessment and management
Panicker, J. N., Fowler, C. J., & Kessler, T. M. (2015) · The Lancet Neurology · doi:10.1016/s1474-4422(15)00070-8 · Cited by 586
Posterior tibial nerve stimulation and faecal incontinence: a review
Findlay, J. M., & Maxwell-Armstrong, C. (2011) · International Journal of Colorectal Disease · doi:10.1007/s00384-010-1085-4 · Cited by 61
Clinical guideline for female lower urinary tract symptoms
TAKAHASHI, S., TAKEI, M., NISHIZAWA, O., YAMAGUCHI, O., KATO, K., GOTOH, M., YOSHIMURA, Y., TAKEYAMA, M., OZAWA, H., SHIMADA, M., et al. (2016) · LUTS: Lower Urinary Tract Symptoms · doi:10.1111/luts.12111 · Cited by 47
Pena, A. E., Kuntaegowdanahalli, S. S., Abbas, J. J., Patrick, J., Horch, K. W., & Jung, R. (2017) · Journal of Neural Engineering · doi:10.1088/1741-2552/aa814d · Cited by 22
Metadata
- Authors
- Peters, K. M., Carrico, D. J., Perez-Marrero, R. A., Khan, A. U., Wooldridge, L. S., Davis, G. L., & MacDiarmid, S. A.
- Venue
- Journal of Urology
- Published
- 2010-04
- Volume
- 183
- Issue
- 4
- Pages
- 1438-1443
- ISSN
- 0022-5347 (ISSN-L)
- 1527-3792
- OpenAlex
- W2154268224
- Cited by
- 489
- References
- 20
- FWCI
- 45.07
- Type
- journal article
- Language
- en
- Open access
- closed
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- Peters, K. M., Carrico, D. J., Perez-Marrero, R. A., Khan, A. U., Wooldridge, L. S., Davis, G. L., & MacDiarmid, S. A. (2010). Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial. Journal of Urology. https://doi.org/10.1016/j.juro.2009.12.036
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