Validation of a Sham for Percutaneous Tibial Nerve Stimulation (PTNS)
Beaumont Hospital, Department of Urology, Royal Oak, Michigan 48073, USA. Neurourology and Urodynamics
(Impact Factor: 2.87).
01/2009; 28(1):58-61. DOI: 10.1002/nau.20585
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.
Available from: Peter L Rosenblatt
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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.
The Journal of urology 08/2009; 182(3):1055-61. DOI:10.1016/j.juro.2009.05.045 · 4.47 Impact Factor
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ABSTRACT: The use of neuromodulation in the treatment of voiding dysfunction and other disorders has become an important mode of therapy
in urology. As use of this therapy has increased, the body of knowledge about the physiology of micturition has grown and
the technology in nerve stimulation has improved. Sacral nerve stimulation is the most frequently used form of neuromodulation,
although other nerve stimulation modalities continue to be developed. Although neuromodulation is an effective treatment,
the exact mechanism of action is unknown. As more light is shed on the appropriate patient selection and eventual treatment
factors that best respond to neuromodulation, this therapy likely will be used earlier in the treatment course and with greater
success. Use of pharmacologic agents such as botulinum toxin type A for chemical neuromodulation may also play an important
role in the management of voiding dysfunction.
Current Bladder Dysfunction Reports 09/2009; 4(3):139-144. DOI:10.1007/s11884-009-0020-4
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ABSTRACT: Overactive bladder (OAB) affects millions of people in the United States, and as the population ages, the prevalence of OAB will invariably increase. Conventional therapy for OAB includes behavioral modification and anticholinergic medication. OAB treatment comes with significant economic impact. With anticholinergic medications often resulting in significant adverse effects and treatment failures, neuromodulation offers an effective treatment modality that is durable and minimally invasive. We argue that neuromodulation, with its high rate of success and significant rate of patient satisfaction, should be offered early in the course of OAB treatment. In addition to sacral neuromodulation, tibial nerve stimulation and chemical neuromodulation offer effective alternative methods of neuromodulation. Neuromodulation is a well-established treatment for "refractory" OAB that deserves a place among traditional treatments for OAB.
Current Urology Reports 10/2009; 10(5):342-6. DOI:10.1007/s11934-009-0054-3 · 1.51 Impact Factor
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