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• W2047813421 abstract "No AccessJournal of UrologyAdult Urology1 Nov 2010Percutaneous Tibial Nerve Stimulation Effects on Detrusor Overactivity Incontinence are Not Due to a Placebo Effect: A Randomized, Double-Blind, Placebo Controlled Trial Enrico Finazzi-Agrò, Filomena Petta, Francesco Sciobica, Patrizio Pasqualetti, Stefania Musco, and Pierluigi Bove Enrico Finazzi-AgròEnrico Finazzi-Agrò Department of Surgery/Urology, Tor Vergata University, Rome, Italy Financial interest and/or other relationship with Astellas, Uroplasty and Bioniche. More articles by this author , Filomena PettaFilomena Petta Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author , Francesco SciobicaFrancesco Sciobica Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author , Patrizio PasqualettiPatrizio Pasqualetti SeSMIT, Service for Medical Statistics and Information Technology, AFaR, Fatebenefratelli Hospital, Isola Tiberina, Rome, Italy More articles by this author , Stefania MuscoStefania Musco Fondazione S. Lucia, Rome, Italy More articles by this author , and Pierluigi BovePierluigi Bove Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2010.06.113AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: This is a prospective, double-blind, placebo controlled study, based on an original placebo technique, performed to evaluate the efficacy of percutaneous tibial nerve stimulation in female patients with detrusor overactivity incontinence. Materials and Methods: A total of 35 female patients presenting with detrusor overactivity incontinence that did not respond to antimuscarinic therapy were randomly assigned to percutaneous tibial nerve stimulation or to a control group. The percutaneous tibial nerve stimulation group (18 patients) was treated with 12 percutaneous tibial nerve stimulation sessions. The control group (17 patients) received an original placebo treatment using a 34 gauge needle placed in the medial part of the gastrocnemius muscle. The sessions lasted for 30 minutes and were performed 3 times weekly as percutaneous tibial nerve stimulation sessions. All patients were evaluated with bladder diaries as well as quality of life scores before and after treatment. Patients showing a reduction in urge incontinence episodes greater than 50% were considered responders. Results: Some patients (1 in the percutaneous tibial nerve stimulation group and 2 in the placebo group) did not complete the study for reasons not related to the technique. Of 17 patients in the percutaneous tibial nerve stimulation group 12 (71%) and of 15 in placebo group 0 were considered responders according to the previously reported definition (p <0.001). Improvement in the number of incontinence episodes, number of voids, voided volume and incontinence quality of life score were statistically significant in the percutaneous tibial nerve stimulation group but not in the placebo group. Conclusions: Percutaneous tibial nerve stimulation can be considered an effective treatment for detrusor overactivity incontinence with 71% of patients considered responders, while none of those treated with placebo was considered a responder. The relevance of a placebo effect seems to be negligible in this patient population. References 1 : Afferent nerve stimulation for pelvic floor dysfunction. Eur Urol1999; 35: 132. Google Scholar 2 : Is pulsed radiofrequency a neuromodulation technique?. Neuromodulation2003; 6: 1. Google Scholar 3 : Posterior tibial nerve stimulation in the treatment of urge incontinence. Neurourol Urodyn2003; 22: 17. 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Link, Google Scholar © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byRogers A, Bragg S, Ferrante K, Thenuwara C and Peterson D (2021) Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm TrialJournal of Urology, VOL. 206, NO. 2, (399-408), Online publication date: 1-Aug-2021.Jiang J, Leung A, Pettitt-Schieber B, Nabavizadeh R, Thomas R, Brown M, Hafford D, Lay A, Hammett J, Carney K, Filson C and Master V (2019) Efficacy of Percutaneous Tibial Nerve Stimulation for Overactive Bladder in Women and Men at a Safety Net HospitalJournal of Urology, VOL. 203, NO. 2, (385-391), Online publication date: 1-Feb-2020.Wein A (2019) Re: Tibial Nerve and Sacral Neuromodulation in the Elderly PatientJournal of Urology, VOL. 203, NO. 3, (469-469), Online publication date: 1-Mar-2020.Moazzam Z, Duke A and Yoo P (2016) Inhibition and Excitation of Bladder Function by Tibial Nerve Stimulation Using a Wirelessly Powered Implant: An Acute Study in Anesthetized CatsJournal of Urology, VOL. 196, NO. 3, (926-933), Online publication date: 1-Sep-2016.Peters K, Carrico D, Wooldridge L, Miller C and MacDiarmid S (2012) Percutaneous Tibial Nerve Stimulation for the Long-Term Treatment of Overactive Bladder: 3-Year Results of the STEP StudyJournal of Urology, VOL. 189, NO. 6, (2194-2201), Online publication date: 1-Jun-2013.Clemens J (2012) ConJournal of Urology, VOL. 187, NO. 6, (1963-1965), Online publication date: 1-Jun-2012.Chen H, Bercik R, Werner E and Thung S (2011) Cost-Effectiveness of Percutaneous Tibial Nerve Stimulation Versus Extended Release Tolterodine for Overactive BladderJournal of Urology, VOL. 187, NO. 1, (178-184), Online publication date: 1-Jan-2012. Volume 184Issue 5November 2010Page: 2001-2006 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.Keywordsurinary incontinenceelectric stimulation therapyplacebostibial nerveMetricsAuthor Information Enrico Finazzi-Agrò Department of Surgery/Urology, Tor Vergata University, Rome, Italy Financial interest and/or other relationship with Astellas, Uroplasty and Bioniche. More articles by this author Filomena Petta Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author Francesco Sciobica Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author Patrizio Pasqualetti SeSMIT, Service for Medical Statistics and Information Technology, AFaR, Fatebenefratelli Hospital, Isola Tiberina, Rome, Italy More articles by this author Stefania Musco Fondazione S. Lucia, Rome, Italy More articles by this author Pierluigi Bove Department of Surgery/Urology, Tor Vergata University, Rome, Italy More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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