Abstract
BACKGROUND: To evaluate the efficacy and safety of a novel remote programming sacral neuromodulation (SNM) system (BetterStim system) in the treatment of patients with refractory overactive bladder (OAB) for 3 years. METHODS: A total of 8 centers in China enrolled 84 patients with OAB. Following test stimulation 70 patients underwent implantation using BetterStim. All patients returned for follow-up at 3 and 6 months postoperatively. After that, the visits were conducted by telephone. Outcomes of voiding diaries, the overactive bladder symptom score (OABSS), questionnaires regarding OAB-related quality of life (OAB-qol), and adverse events (AEs) were evaluated at each visit. The clinical therapeutic success was defined as ≥50% improvement from baseline in any of the voiding diary variables or average voids/day return to normal voiding (<8 voids/day). The analysis is a modified Completers analysis. RESULTS: At the 36-month follow-up, the success rate was 79% for overall OAB symptoms, 69% for urge urinary incontinence (UUI) and 42% for urgency frequency (UF). The average number of voids/day decreased from 29.2±14.9 at baseline to 17.6±11.2 at 3 years, the average volume/void increased from 94.7±54.2 to 151.4±80.8 mL, the urgency reduced from 3.0±1.4 to 1.8±1.7 (all P<0.001). For patients with urge incontinence, mean leaking episodes/day decreased from 8.1±7.6 at baseline to 2.1±3.5 at three years (P<0.05). The devices were explanted in 8 (11.4%) patients. There were no remote programming-related AEs or device-related serious AEs that occurred. CONCLUSIONS: The Intermediate-term results demonstrated that BetterStim SNM system with remote programming is safe and effective for patients with refractory OAB.