INTRODUCTION AND OBJECTIVES: Overactive bladder syndrome (OAB) affects the lives of millions of people. Neuromodulation therapy uses electrical stimulation to target specific nerves in the sacral plexus that control bladder function. Urgent® PC percutaneous tibial nerve stimulation (PTNS) targets the sacral plexus from an accessible, minimally invasive entry point into the nervous system at the posterior tibial nerve. The objective of this review is to evaluate the clinical outcomes of PTNS in the 23-center SUmiT Trial.
METHODS: 220 subjects were randomized 1:1 to PTNS or validated sham as part of their participation in the SUmiT Trial. Subjects received 12 PTNS or sham treatments during 30-minute weekly sessions. Subjects completed questionnaires and 3-day voiding diaries during their participation.
RESULTS: In an intent-to-treat analysis, the Global Response Assessment (GRA) found 54.5% were responders (moderately or markedly improved) in the PTNS group compared to 20.9% in the sham group (p<0.001). All GRA outcomes were statistically significant at 13 weeks compared to baseline, but outcomes were not significant at 7 weeks, see table. Similarly, OAB-q quality of life questionnaires were statistically significant for improvement at 13 weeks, but not significant at 7 weeks between treatment groups. GRA outcomes at 13 weeks in those previously treated with an OAB medication were higher than those naive to pharmacotherapy, 62.9% compared to 48.5% for the PTNS arm. When results are stratified by age, <65yrs vs. ≥65 yrs, no significant difference in efficacy was found in either study arm. The mean age was 62.5 years and 60.2 years, PTNS and sham, respectively. No significant changes in sexual function indices were reported by either study arm or gender (174 females, 46 males). No serious treatment related adverse events were reported.
CONCLUSIONS: Based upon the GRA and OAB-q quality of life response outcomes at 7 and 13 weeks, 12 weekly sessions of PTNS treatments are needed for the treatment to be efficacious for those suffering with OAB syndrome. PTNS therapy is an efficacious treatment for those suffering with OAB syndrome, regardless of age.
Source: Original Poster
