Six-Month Outcomes of Reimplantation of a Coin-Sized Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome With Urgency Urinary Incontinence

Bilal Kaaki, Sharon English, Peter Gilling, Patrick Meffan, Vincent Lucente, Scott MacDiarmid, Matthew Clark, Subhro K Sen, Bilal Kaaki, Sharon English, Peter Gilling, Patrick Meffan, Vincent Lucente, Scott MacDiarmid, Matthew Clark, Subhro K Sen

Abstract

Objective: The eCoin (Valencia Technologies Corporation, Valencia, CA) is a battery-powered, nickel-sized and shaped neuromodulation device for the treatment of overactive bladder, and it is implanted in the lower leg in a short office or outpatient procedure under local anesthesia. A follow-on trial was conducted to evaluate the feasibility, safety, and efficacy of eCoin reimplantation.

Methods: This was a prospective, single-arm, open-label study, including 23 participants with refractory urgency urinary incontinence (UUI) who were previously participants in the eCoin clinical feasibility trial. This follow-on study was conducted at 7 sites in the United States and New Zealand. Participants were reimplanted with a new eCoin device and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 12 weeks and 24 weeks postactivation, were compared with baseline.

Results: Participants of the study were considered responders if they reported a ≥ 50% reduction from baseline in episodes of UUI on a 3-day voiding diary. At 12 weeks of treatment, 74% (95% confidence interval [CI], 52%-90%) of participants were considered responders. At 24 weeks of treatment, 82% (95% CI, 60%-95%) of participants were considered responders with 36% (95% CI, 20%-57%) of participants achieving complete continence. There were no device-related serious adverse events reported during the study.

Conclusions: The reimplantation of eCoin was both safe and effective in treating UUI associated with overactive bladder syndrome. The demonstrated significant reduction or resolution of symptoms with no serious safety concern suggests that eCoin is a convenient and maintainable therapeutic device.

Trial registration: ClinicalTrials.gov NCT03655054 NCT03029624.

Conflict of interest statement

B.K. declares that he serves as a consultant for Valencia Technologies, was an investigator on this Valencia-sponsored clinical trial, and owns minor equity interest in the company. S.K.S. declares that he has been compensated as a consultant for Valencia Technologies, and owns stock options representing less than 0.01% of the company. The remaining authors have declared they have no conflicts of interest. The authors who own a minor equity interest in the company constitute a very small percentage; all authors constitute less than 0.1% of the company. Furthermore, this potential conflict of interest was addressed according to the recommendations of the local and central IRBs including: (i) Having a statement in the informed consent stating the PI own a minority stake, and disclosing the potential conflict of interest for which the participant has to sign. (ii) The data collected for this study come from a voiding diary and quality of life questionnaires, which are filled out by the participants. The PIs and Clinical Research Coordinators (CRCs) were not allowed to revise or write on these forms. If any formatting edits were made, the participants were asked to change and initial the change themselves. (iii) Clinical Research Coordinators had no conflict of interest and they were the individuals who scanned and sent the raw data.

Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.

Figures

FIGURE 1
FIGURE 1
Average improvement in urgency urinary incontinence (UUI) in all participants with implants at 12 weeks of therapy (n = 23) and at 24 weeks of therapy (n = 22), showing sustained continuous improvement in therapy over duration of study.

References

    1. Choo MS Ku JH Lee JB, et al. . Cross-cultural differences for adapting overactive bladder symptoms: results of an epidemiologic survey in Korea. World J Urol 2007;25:505–511. doi:10.1007/s00345-007-0183-6.
    1. Corcos J, Schick E. Prevalence of overactive bladder and incontinence in Canada. Can J Urol 2004;11:2278–2284.
    1. Coyne KS Sexton CC Vats V, et al. . National community prevalence of overactive bladder in the United States stratified by sex and age. Urology 2011;77:1081–1087. doi:10.1016/j.urology.2010.08.039.
    1. Herschorn S Gajewski J Schulz J, et al. . A population-based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey. BJU Int 2008;101:52–58. doi:10.1111/j.1464-410X.2007.07198.x.
    1. Irwin DE Milsom I Hunskaar S, et al. . Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol 2006;50:1306–1314. doi:10.1016/j.eururo.2006.09.019.
    1. Milsom I Abrams P Cardozo L, et al. . How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int 2001;87:760–766. doi:10.1046/j.1464-410x.2001.02228.x.
    1. Stewart WF Van Rooyen JB Cundiff GW, et al. . Prevalence and burden of overactive bladder in the United States. World J Urol 2003;20:327–336. doi:10.1007/s00345-002-0301-4.
    1. Tikkinen KA Auvinen A Tiitinen A, et al. . Reproductive factors associated with nocturia and urinary urgency in women: a population-based study in Finland. Am J Obstet Gynecol 2008;199:153.e1–153.e12. doi:10.1016/j.ajog.2008.03.054.
    1. Reynolds WS, Fowke J, Dmochowski R. The burden of overactive bladder on US public health. Curr Bladder Dysfunct Rep 2016;11:8–13. doi:10.1007/s11884-016-0344-9.
    1. Du C Berg WT Siegal AR, et al. . A retrospective longitudinal evaluation of new overactive bladder patients in an FPMRS urologist practice: are patients following up and utilizing third-line therapies? Neurourol Urodyn 2021;40:391–396. doi:10.1002/nau.24573.
    1. McPherson A. The effects of somatic stimuli on the bladder in the cat. J Physiol 1966;185:185–196. doi:10.1113/jphysiol.1966.sp007980.
    1. Vandoninck V Van Balken MR Finazzi Agró E, et al. . Posterior tibial nerve stimulation in the treatment of urge incontinence. Neurourol Urodyn 2003;22:17–23. doi:10.1002/nau.10036.
    1. MacDiarmid S Staskin DR Lucente V, et al. . Feasibility of a fully implanted, nickel sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence. J Urol 2019;201:967–972. doi:10.1016/j.juro.2018.10.017.
    1. Patrick DL Martin ML Bushnell DM, et al. . Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology 1999;53:71–76. doi:10.1016/s0090-4295(98)00454-3.
    1. Yalcin I Patrick DL Summers K, et al. . Minimal clinically important differences in incontinence quality-of-life scores in stress urinary incontinence. Urology 2006;67:1304–1308. doi:10.1016/j.urology.2005.12.006.
    1. Te Dorsthorst MJ, Heesakkers JPFA, van Balken MR. Long-term real-life adherence of percutaneous tibial nerve stimulation in over 400 patients. Neurourol Urodyn 2020;39:702–706. doi:10.1002/nau.24254.
    1. Peters KM Killinger KA Gilleran JP, et al. . Predictors of reoperation after sacral neuromodulation: a single institution evaluation of over 400 patients. Neurourol Urodyn 2017;36:354–359. doi:10.1002/nau.22929.
    1. Shih C Miller JL Fialkow M, et al. . Reoperation after sacral neuromodulation therapy: a single-institution experience. Female Pelvic Med Reconstr Surg 2013;19:175–178. doi:10.1097/SPV.0b013e31828ab3c9.
    1. Yazdany T, Bhatia N, Nguyen J. Determining outcomes, adverse events, and predictors of success after sacral neuromodulation for lower urinary disorders in women. Int Urogynecol J 2011;22:1549–1554. doi:10.1007/s00192-011-1512-2.

Source: PubMed

Szponzorok és közreműködők

Egészségi állapot

Kábítószer-beavatkozások

3
Iratkozz fel