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Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.
J Urol. 2009 Sep; 182(3):1055-61.JU

Abstract

PURPOSE

The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated.

MATERIALS AND METHODS

A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy.

RESULTS

The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions.

CONCLUSIONS

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.

Authors+Show Affiliations

William Beaumont Hospital, Royal Oak, Michigan, USA. kmpeters@beaumont.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19616802

Citation

Peters, Kenneth M., et al. "Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial." The Journal of Urology, vol. 182, no. 3, 2009, pp. 1055-61.
Peters KM, Macdiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol. 2009;182(3):1055-61.
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., & Feagins, B. A. (2009). Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. The Journal of Urology, 182(3), 1055-61. https://doi.org/10.1016/j.juro.2009.05.045
Peters KM, et al. Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial. J Urol. 2009;182(3):1055-61. PubMed PMID: 19616802.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. AU - Peters,Kenneth M, AU - Macdiarmid,Scott A, AU - Wooldridge,Leslie S, AU - Leong,Fah Che, AU - Shobeiri,S Abbas, AU - Rovner,Eric S, AU - Siegel,Steven W, AU - Tate,Susan B, AU - Jarnagin,Barry K, AU - Rosenblatt,Peter L, AU - Feagins,Brian A, Y1 - 2009/07/18/ PY - 2009/02/04/received PY - 2009/7/21/entrez PY - 2009/7/21/pubmed PY - 2009/9/9/medline SP - 1055 EP - 61 JF - The Journal of urology JO - J. Urol. VL - 182 IS - 3 N2 - PURPOSE: The Overactive Bladder Innovative Therapy trial was a randomized, multicenter, controlled study that compared the effectiveness of percutaneous tibial nerve stimulation to extended-release tolterodine. The reduction in overactive bladder symptoms along with global response assessments was evaluated. MATERIALS AND METHODS: A total of 100 adults with urinary frequency were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or to 4 mg daily extended-release tolterodine. Voiding diaries and an overactive bladder questionnaire were completed at baseline and at the end of therapy to compare 24-hour voiding frequency, urinary urge incontinence episodes, voids causing waking, volume voided, urgency episodes and quality of life indices. Global response assessments were completed by subjects and investigators after 12 weeks of therapy. RESULTS: The global response assessment demonstrated that subject assessment of overactive bladder symptoms compared to baseline was statistically significant in the percutaneous tibial nerve stimulation arm with 79.5% reporting cure or improvement compared to 54.8% of subjects on tolterodine (p = 0.01). Assessments by investigators were similar but did not reach statistical significance (p = 0.05). After 12 weeks of therapy objective measures improved similarly in both groups for reductions in urinary frequency, urge urinary incontinence episodes, urge severity and nighttime voids, as well as for improvement in voided volume. There were no serious adverse events or device malfunctions. CONCLUSIONS: 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. SN - 1527-3792 UR - https://www.unboundmedicine.com/medline/citation/19616802/Randomized_trial_of_percutaneous_tibial_nerve_stimulation_versus_extended_release_tolterodine:_results_from_the_overactive_bladder_innovative_therapy_trial_ L2 - https://www.jurology.com/doi/full/10.1016/j.juro.2009.05.045?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -