A Prospective Study to Evaluate Efficacy Using the Nuro Percutaneous Tibial Neuromodulation System in Drug-Naïve Patients With Overactive Bladder Syndrome

Objective: To evaluate changes from baseline in urgency urinary incontinence episodes, urinary frequency and quality of life through 12 weeks of percutaneous tibial neuromodulation (PTNM) therapy using NURO in drug-naïve overactive bladder syndrome (OAB) subjects. Methods: Eligible subjects underwent 12 weekly PTNM sessions with the NURO system. Changes in voiding symptoms were evaluated with bladder diaries from baseline through 12 weeks. Analyses were conducted for subjects with data at baseline and follow-up visits (sessions 1, 4, 8, and 12). Safety was evaluated through adverse events (AE) related to the device, procedure, and therapy. Results: Of 154 subjects enrolled in the study,120 subjects met study criteria and received PTNM. The mean age was 64.8 years, mean duration of OAB diagnosis was 3.4 years and 86% female subjects. No subjects tried OAB medication prior to enrollment. At baseline, patients had 3.5 ± 2.5 (mean ± SD) UUI episodes/day. Statistically significant improvement in urgency urinary incontinence episodes from baseline was observed at each follow-up visit (P < .0001), with a reduction of 2.4 ± 2.1 episodes after session 12 from baseline. Subjects with urinary frequency at baseline had 11.5 ± 2.9 voids/day. After session 12, a statistically significant reduction of 1.7 ± 2.5 voids/day was observed (P < .0001). Ninety-six percent (116/120) of subjects completed the study with diary data for the primary objective with an average of 11.6 sessions. There were no serious or unanticipated AEs. The most common AEs were medical device site pain (3.3%, 4/121) and extremity pain (3.3%, 4/121). Conclusion: PTNM using NURO is an effective and safe treatment for drug-naïve patients with OAB.