Research article summary (published 16 Jul 2009):

Randomized trial of percutaneous tibial nerve stimulation versus extended-release tolterodine: results from the overactive bladder innovative therapy trial.

Full 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.

Author information

Author/s: Peters, Kenneth M (KM); Macdiarmid, Scott A (SA); Wooldridge, Leslie S (LS); Leong, Fah Che (FC); Shobeiri, S Abbas (SA); Rovner, Eric S (ES); Siegel, Steven W (SW); Tate, Susan B (SB); Jarnagin, Barry K (BK); Rosenblatt, Peter L (PL); Feagins, Brian A (BA);

Affiliation: William Beaumont Hospital, Royal Oak, Michigan, USA. kmpeters(-atsign-)beaumont.edu

Journal and publication information

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

Journal: The Journal of urology (J Urol), published in United States. (Language: eng)

Reference: 2009-Sep; vol 182 (issue 3) : pp 1055-61

Dates: Created 2009/08/13; Completed 2009/09/08;

PMID: 19616802, status: MEDLINE (last retrieval date: 9/8/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Adult Aged Aged, 80 and over Benzhydryl Compounds - therapeutic use Cresols - therapeutic use Delayed-Action Preparations Electric Stimulation Therapy Female

Humans Male Middle Aged Muscarinic Antagonists - therapeutic use Phenylpropanolamine - therapeutic use Tibial Nerve Urinary Bladder, Overactive - drug therapy; therapy Young Adult

Associated Chemicals: Benzhydryl Compounds (0) ; Cresols (0) ; Delayed-Action Preparations (0) ; Muscarinic Antagonists (0) ; tolterodine (124937-51-5) ; Phenylpropanolamine (14838-15-4)

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