The emergence of ITNM represents a trend toward less-invasive surgical approaches to treat UUI. Sacral systems involve multiple implanted components (lead + battery) and peripherals (programmers and rechargers when applicable), while current ITNM systems have one implanted component along with peripherals. Unlike all other ITNM systems, Revi does not have an implanted battery. Energy is transmitted from an ankle cuff to a receiver within the otherwise inert implant.
This prospective multicenter study evaluated the Revi System in 151 women with UUI. Safety and eOectiveness outcomes at 12 and 24 months for this patient cohort have been published.4,5 In this paper, QoL outcomes are reported, including: 1) Overactive Bladder Questionnaire (assessing QoL and symptom severity), Patient Global Impression of
Improvement (gauging the response to a therapy), and Treatment Benefit, Satisfaction, and Willingness to Continue (delineating the patient’s perception of ITNM in consideration of relative benefit, satisfaction, and intention or willingness to continue therapy). These assessments were completed 6 months, 12 months, and 24 months after treatment initiation. Significant improvements were reported in QoL measures.
This is the first in-depth evaluation of QoL improvement and perception of treatment benefit among patients in this study. Our findings demonstrate the clinically significant and sustained improvements in patient-reported subjective outcomes that ITNM can provide. Patient satisfaction rates exceeded 95% with the Revi System, surpassing even the primary eOicacy success rates of ~80%. Even among the ~20% of patients who did not meet the primary efficacy threshold (>50% improvement in UUI), 83% still noted treatment satisfaction, and all patients (100%) reported improvements that were deemed worthy of continued ITNM therapy. This indicates that subjective improvements may be more influential than absolute objective measures when patients consider treatment options, and the continuation thereof, for their bladder symptoms.
Written by: Suzette E. Sutherland, MD, MS,1 John PFA Heesakkers, MD,2 Kimberly L. Ferrante, MD,3 Roger R. Dmochowski, MD,4
- Arizona Urology Specialists - United Urology Group, Scottsdale, AZ.
- Department of Urology, Maastricht UMC, Maastricht, The Netherlands.
- Kaiser Permanente, San Diego, CA, USA.
- Vanderbilt University Medical Center, Nashville, TN, USA
- Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, Chapple CR. Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. Eur Urol. Jan 2012;61(1):88–95. doi:10.1016/j.eururo.2011.07.049
- Schmidt RA, Jonas U, Oleson KA, et al. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol. Aug 1999;162(2):352–7.
- van Balken MR, Vandoninck V, Gisolf KW, et al. Posterior tibial nerve stimulation as neuromodulative treatment of lower urinary tract dysfunction. J Urol. Sep 2001;166(3):914–doi:10.1097/00005392-200109000-00025
- Heesakkers J, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and safety of the BlueWind System in the treatment of patients diagnosed with urgency urinary incontinence. Neurourol Urodyn. Sep 2024;43(7):1491–1503. doi:10.1002/nau.25477
- Heesakkers J, Toozs-Hobson P, Sutherland SE, et al. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence. J Urol. Mar 2025;213(3):323–332. doi:10.1097/JU.0000000000004328