Validation of a Sham for Percutaneous Tibial Nerve Stimulation (PTNS)
ABSTRACT Percutaneous tibial nerve stimulation (PTNS) supposedly demonstrates 50-60% improvement in OAB symptoms with no sham-controlled trials reported. This study determined the efficacy of a sham for PTNS.
Thirty healthy volunteers (15 women; 15 men) in this blinded pilot study were randomized into two equal groups: one group had PTNS on the right and sham on the left; the other group had PTNS on the left and sham on the right. A drape obscured their lower extremities. The sham utilized a placebo needle placed at the PTNS site along with a transcutaneous electrical nerve stimulator (TENS) pad on the ipsilateral foot. The unit was activated until stimulation was felt. PTNS was performed on the opposite leg, with the grounding pad mimicking the sham pad placement. PTNS stimulation was given until the subject felt stimulation in the foot. Subjects had 1 simultaneous 15 min testing of the PTNS vs. sham. Subjects then completed a questionnaire stating which leg they thought had the sham and PTNS (or "unknown"). The primary endpoint of the study was the ability to accurately identify the sham.
In total, 10/30 (33%) of the shams were identified correctly. We would expect 50% to be identified by guessing, but only 33% were correctly identified. Females identified the sham correctly more often than males (40% vs. 27%). This procedure was validated as a feasible sham for PTNS.
This is the first validation of a sham for PTNS that may be used in future placebo-controlled research.
SourceAvailable from: Luca Topazio[Show abstract] [Hide abstract]
ABSTRACT: Percutaneous Tibial Nerve Stimulation (PTNS) has been proposed for the treatment of overactive bladder syndrome (OAB), non-obstructive urinary retention (NOUR), neurogenic bladder, paediatric voiding dysfunction and chronic pelvic pain/painful bladder syndrome (CPP/PBS). Despite a number of publications produced in the last ten years, the role of PTNS in urinary tract dysfunctions remains unclear. A systematic review of the papers on PTNS has been performed with the aim to better clarify potentialities and limits of this technique in the treatment of OAB syndrome and in other above mentioned urological conditions. A literature search using MEDLINE and ISI web was performed. Search terms used were "tibial nerve" and each of the already mentioned conditions, with no time limits. An evaluation of level of evidence for each paper was performed. PTNS was found to be effective in 37-100% of patients with OAB, in 41-100% of patients with NOUR and in up to 100% of patients with CPP/PBS, children with OAB/dysfunctional voiding and patients with neurogenic pathologies. No major complications have been reported.Randomized controlled trials are available only for OAB (4 studies) and CPP/PBS (2 studies). Level 1 evidence of PTNS efficacy for OAB is available. Promising results, to be confirmed by randomized controlled studies, have been obtained in the remaining indications considered. PTNS is an effective and safe option to treat OAB patients. Further studies are needed to assess the role of PTNS in the remaining indications and to evaluate the long term durability of the treatment. Further research is needed to address several unanswered questions about PTNS.BMC Urology 11/2013; 13(1):61. DOI:10.1186/1471-2490-13-61 · 1.94 Impact Factor
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ABSTRACT: Overactive bladder is a significant health problem for individuals of all ages. Posterior tibial nerve stimulation for overactive bladder is not a new concept, but providers and some third party payers have been slow to embrace it. Until recently, lack of level 1 evidence had raised questions as to its efficacy and duration of benefit. Level 1 evidence now exists to support its use for the treatment of overactive bladder. However, questions remain as to the durability of the benefit. It is likely that chronic maintenance therapy will be necessary in most cases. Emerging evidence may expand the indications for posterior tibial nerve stimulation to include multiple sclerosis, Parkinson’s disease, childhood voiding dysfunction, fecal incontinence, interstitial cystitis, and chronic prostatitis. New methods for stimulating this nerve without needles may someday replace current techniques.Current Bladder Dysfunction Reports 03/2011; 7(1). DOI:10.1007/s11884-011-0113-8
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ABSTRACT: Overactive bladder (OAB) is one of the most common bothersome urological diseases. It also has a negative economic impact. Pathophysiology entails changes in neurogenic and myogenic factors, as well as urinary biomarkers such as nerve growth factor (NGF) and prostaglandins (PGs). With symptoms from OAB-Dry to OAB-Wet, the urodynamic pattern of OAB bladder is often characterized by idiopathic detrusor overactivity with lower threshold of sensation, diminished compliance and capacity. Treatment ranges from a combination of behavioral modifications (BM)/ pelvic floor muscle training (PFMT) to combinations of antimuscarinics, Botox injection, nerve stimulation and augmentation cystoplasty. Herein, a contemporary review on the different aspects of management of refractory OAB in patients without neuropathic disorders is presented.Current Urology Reports 09/2014; 15(9):438. DOI:10.1007/s11934-014-0438-x