Ramon Perez-Marrero

Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial

PURPOSE The Study of Urgent PC vs Sham Effectiveness in Treatment of Overactive Bladder Symptoms (SUmiT) was a multicenter, double-blind, randomized, controlled trial comparing the efficacy of percutaneous tibial nerve stimulation to sham through 12 weeks of therapy. The improvement in global response assessment, voiding diary parameters, and overactive bladder and quality of life questionnaires was evaluated. MATERIALS AND METHODS A total of 220 adults with overactive bladder symptoms were randomized 1:1 to 12 weeks of treatment with weekly percutaneous tibial nerve stimulation or sham therapy. Overactive bladder and quality of life questionnaires as well as 3-day voiding diaries were completed at baseline and at 13 weeks. Subject global response assessments were completed at week 13. RESULTS The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p <0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported. CONCLUSIONS This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.

THE EFFECTS OF TRANSURETHRAL NEEDLE ABLATION AND RESECTION OF THE PROSTATE ON PRESSURE FLOW URODYNAMIC PARAMETERS: ANALYSIS OF THE UNITED STATES RANDOMIZED STUDY

PURPOSE We evaluated the effects of transurethral needle ablation and prostate resection on pressure flow urodynamic parameters in men with benign prostatic hyperplasia (BPH), compared symptomatic and objective parameters of efficacy 6 months after initial treatment, and determined whether urodynamic assessment may predict symptomatic improvement. MATERIALS AND METHODS We enrolled 121 patients with clinical BPH, American Urological Association symptom index of 13 or greater and maximum urinary flow of 12 ml. per second or less in a randomized study comparing transurethral needle ablation to prostate resection at 7 institutions in the United States. Patients underwent baseline and followup assessments at 6 months, including pressure flow studies. RESULTS Patients who underwent each procedure had statistically and clinically significant improvement in symptom index, BPH impact index and quality of life score. After needle ablation and prostate resection maximum flow improved from 8.8 to 13.5 (p<0.0001) and 8.8 to 20.8 ml. per second (p<0.0001), detrusor pressure at maximum flow decreased from 78.7 to 64.5 (p = 0.036) and 75.8 to 54.9 cm. water (p<0.001), and the Abrams-Griffiths number decreased from 61.2 to 37.2 (p<0.001) and 58.3 to 10.9 (p<0.001), respectively. At 6 months the differences in transurethral needle ablation and prostate resection were significant in terms of maximum flow (p<0.001) and the Abrams-Griffiths number (p<0.001) but not detrusor pressure at maximum flow or symptom assessment tools. The presence or absence of urinary obstruction at baseline did not predict the degree of symptomatic improvement in either treatment group. CONCLUSIONS Transurethral needle ablation and prostate resection induce statistically and clinically significant improvement in various quantitative symptom assessment questionnaires at 6 months. The parameters of free flow rates and invasive pressure flow studies also significantly improve after each treatment. However, transurethral prostate resection induces a significantly greater decrease in the parameters of obstruction. Baseline urodynamic parameters do not predict the degree of symptomatic improvement and they may not be helpful in patient selection for transurethral needle ablation.