Novel, rechargeable sacral neuromodulation system improves quality of life in overactive bladder subjects at three-month followup in a global, prospective, post-market study
Dean Elterman1, Colin Goudelocke2, Keith Xavier3, Barry Pecha4, Kimberly Burgess5, Marie-Aimée Perrouin-Verbe6, Ryan Krlin7, Jodi Michaels8, Sagar Shah9, Benoît Peyronnet10, Stanley Zaslau11, Bianca Papi12, Katie Bittner12, Victor Nitti13.
1Division of Urology, University of Toronto, Toronto, ON, Canada; 2Department of Urology, Ochner Medical Center, New Orleans, LA, United States; 3Urology Partners of North Texas, Arlington, TX, United States; 4First Urology, Jeffersonville, IN, United States; 5Prisma Health, Greenville, SC, United States; 6Department of Urology, Centre Hospitalier Universitaire de Nantes, Nantes , France; 7Department of Urology, Louisiana State University Health Sciences Center, New Orleans , LA, United States; 8Center for Continence Care, Minnesota Urology, Woodbury, MN, United States; 9East Coast Institute for Research LLC, Jacksonville, FL, United States; 10Department of Urology, Centre Hospitalier Universitaire de Rennes, Rennes , France; 11Department of Urology, West Virginia University, Morgantown, WV, United States; 12Medtronic, Minneapolis, MN, United States; 13Female Pelvic Medicine and Reconstructive Surgery, University of California Los Angeles, Los Angeles , CA, United States
Introduction: Sacral neuromodulation (SNM) is a therapy for overactive bladder (OAB). ELITE is an ongoing global, prospective, post-market study to confirm the clinical performance and safety of a novel, rechargeable SNM system for OAB, fecal incontinence, and non-obstructive urinary retention. We report the three-month quality of life results from the OAB cohort.
Methods: Subjects were enrolled following a successful therapy evaluation (physician discretion, recommended 50% improvement in symptoms) and neurostimulator implant. Subjects completed the OAB Quality of Life Questionnaire (OAB-q) and voiding diaries at baseline and at three months. Safety was evaluated by the collection of reportable adverse events.
Results: Sixty-eight subjects were enrolled with the full system implanted. Enrolled subjects met all inclusion and no exclusion criteria. The mean age was 62±13 years, body mass index was 32±7, and years since diagnosis was 10±8. Most subjects were female (90%) and 71% had a primary diagnosis of both urinary urge incontinence and urgency frequency. Mean baseline Health-Related Quality of Life score (HRQL) was 44±22. HRQL demonstrated significant improvement from baseline to three months, with a mean increase of 33±24 points (n=67, p<0.001). Eighty-two percent of subjects achieved the minimally important difference (MID, ≥10 points) in HRQL score. The change in score for all other OABq domains (concern, coping, sleep, social) was 2–3x the MID. The cumulative incidence of device-, procedure-, or therapy-related adverse events was 2.9% (2/68). There was one serious adverse event (1.5%, neurostimulator implant site pain).
Conclusions: These data confirm the safety and clinical performance of a novel, rechargeable SNM system for subjects with OAB. These data fortify the established SNM evidence with data from the rechargeable SNM system by demonstrating improvement of OAB-q scores at three months post-implant. The incidence of adverse events is favorable compared to previous reports for SNM.
