Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Extended-Release Tolterodine: Results From the Overactive Bladder Innovative Therapy Trial
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- 30 September 2009
- journal article
- research article
- Published by Ovid Technologies (Wolters Kluwer Health) in Journal of Urology
- Vol. 182 (3), 1055-1061
- https://doi.org/10.1016/j.juro.2009.05.045
Abstract
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. 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. 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. 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.Keywords
This publication has 20 references indexed in Scilit:
- Relationships between improvements in symptoms and patient assessments of bladder condition, symptom bother and health-related quality of life in patients with overactive bladder treated with tolterodineInternational Journal of Clinical Practice, 2008
- Impact of overactive bladder on women in the United States:results of a national surveyCurrent Medical Research and Opinion, 2006
- Management of refractory urinary urge incontinence following urogynecological surgery with sacral neuromodulationNeurourology and Urodynamics, 2006
- Current opinion on the working mechanisms of neuromodulation in the treatment of lower urinary tract dysfunctionCurrent Opinion in Urology, 2006
- How sacral nerve stimulation neuromodulation worksUrologic Clinics of North America, 2005
- The Unstable DetrusorUrologia Internationalis, 2004
- Describing bladder storage function: overactive bladder syndrome and detrusor overactivityUrology, 2003
- Neuromodulation Techniques for the Treatment of the Overactive BladderClinical Obstetrics and Gynecology, 2002
- PERCUTANEOUS AFFERENT NEUROMODULATION FOR THE REFRACTORY OVERACTIVE BLADDER: RESULTS OF A MULTICENTER STUDYJournal of Urology, 2001
- SACRAL NERVE STIMULATION FOR TREATMENT OF REFRACTORY URINARY URGE INCONTINENCEJournal of Urology, 1999