A prospective, multicenter study of a novel, miniaturized rechargeable sacral neuromodulation system: 12‐month results from the RELAX‐OAB study. Issue 2 (28th December 2018)

• Record Type: Journal Article
• Authors: Blok, Bertil; Van Kerrebroeck, Philip; de Wachter, Stefan; Ruffion, Alain; Van der Aa, Frank; Jairam, Ranjana; Perrouin‐Verbe, Marie Aimée; Elneil, Sohier
• Is Part Of: Neurourology and urodynamics. Volume 38:Issue 2(2019:Feb.)
• Page Start: 689
• Page End: 695
• Publication Date: 2018-12-28
• Subjects: overactive bladder -- rechargeable -- sacral neuromodulation -- single stage implant -- urgency frequency -- urinary incontinence; Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.23892
• Languages: English
• ISSNs: 0733-2467

Abstract

Abstract : Aims: Historically, providing SNM therapy required use of a non‐rechargeable implantable pulse generator (IPG) with an average device lifespan of 4.4 years. Multiple device replacement surgeries are necessary with this device for long‐term overactive bladder (OAB) management. A longer‐lived device can reduce and potentially eliminate the need for replacement surgeries, thereby improving the long‐term safety and cost‐effectiveness of SNM therapy. The objective of this study was to evaluate the safety and efficacy of a miniaturized, rechargeable SNM system. Methods: This prospective, multi‐center study implanted 51 subjects with the SNM system in a single stage procedure without an external trial period. Subjects had overactive bladder as demonstrated on a 3‐day voiding diary (≥8 voids/day and/or ≥2 incontinence episodes over 72‐h). Outcome measures at 1‐year follow‐up included quality of life (evaluated by ICIQ‐OABqol questionnaire), therapy responder rates (≥50% reduction in voids and/or leaks or <8 voids per day), subject satisfaction questionnaire, and adverse events (AEs). Results: At 1‐year, 94% of Test Responders continued to respond to r‐SNM therapy based on bladder diary criteria. Subjects experienced significant improvement of 21.1 points on the ICIQ‐OABqol. 84% of subjects were satisfied with r‐SNM therapy and 98% found their charging experience acceptable. Device‐related AEs occurred in 21% of subjects, with discomfort due to stimulation occurring in 20% of subjects. This AE was resolved with reprogramming in all instances. Conclusions: The Axonics r‐SNM System provides sustained clinically significant improvements in OAB subjects after 1‐year. Subjects were satisfied with r‐SNM therapy and reported an easy and acceptable recharging experience.