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Device-Related Reoperations 8 Years Following Sacral Neuromodulation Implantation in Older Women

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Abstract

Introduction and Hypothesis

The objective was to describe long-term device-related reoperations at 8 years following sacral neuromodulation (SNM) in women older than 65 years for the indications of overactive bladder (OAB), fecal incontinence (FI), and/or idiopathic urinary retention (UR).

Methods

The 2010–2019 Medicare 100% Outpatient Limited Dataset was used to identify women aged 65 years and older who underwent SNM to treat OAB, FI, and/or UR. The primary study outcome was any device-related reoperation within 8 years following initial implantable pulse generator (IPG) implantation defined as: IPG revision or removal; IPG replacement; or neuro-electrode revision or removal. Kaplan–Meier survival analysis was also performed to evaluate time to adverse event.

Results

The cohort included 32,454 women with a mean age of 74 years. The most common indication for SNM was OAB (71%) followed by UI and FI (13%) and FI only (8%). Staged SNM procedures were performed more frequently (60%) than percutaneous nerve evaluation/full implants. The overall rate of device-related reoperations was 24% over 8 years: 12% of patients underwent removal or revision of the neuro-electrode, 11% underwent removal or revision of the IPG, and 13% underwent replacement of the IPG. The mean follow-up was 3.9 ± 2.4 years. The cumulative incidence of any device-related reoperations was 9.4% at 1 year, 20% at 3 years, and 43% at 8 years.

Conclusions

In the 8 years following SNM implantation, the rate of device-related reoperation among female Medicare beneficiaries was 43%, and staged implants were associated with a 17% lower likelihood of undergoing any device-related reoperations.

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Data Availability

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

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Funding

Research reported in this publication was supported, in part, by the National Institutes of Health's National Institute on Aging, Grant Number P30AG059988. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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Authors and Affiliations

  1. Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

    C. Emi Bretschneider

  2. Division of Female Pelvic Medicine and Reconstructive Surgery, Urology Institute, University Hospitals, Cleveland, OH, USA

    David Sheyn

  3. Biostatistics Collaboration Center, Northwestern University, Chicago, IL, USA

    Nicola Lanki

  4. Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Lena Volpe

  5. Division of Female Pelvic Medicine and Reconstructive Surgery, University of Louisville Health, Louisville, KY, USA

    Ankita Gupta

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  1. C. Emi Bretschneider
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Contributions

C.E.B.: concept development, data analysis, manuscript writing and editing; D.S.: concept development, data analysis, manuscript writing and editing; N.L.: data analysis, manuscript writing and editing; L.V.: manuscript writing and editing; A.G.: concept development, data analysis, manuscript writing and editing.

Corresponding author

Correspondence to C. Emi Bretschneider.

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Ethical/Institutional Review Board Approval

Northwestern’s IRB deemed this study exempt.

Conflicts of Interest

C.E.B. is a consultant for Boston Scientific. D.S. received research funding from Renalis, Axonics, Metronic, Vikor Scientific, Revi, NIA, NICHD, and AHRQ; is a consultant for Caldera Medical; and holds stock in CollaMedix. The other authors have no conflicts of interest to report.

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Handling Editor: Jaromir Masata

Editor in Chief: Maria A. Bortolini

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Bretschneider, C.E., Sheyn, D., Lanki, N. et al. Device-Related Reoperations 8 Years Following Sacral Neuromodulation Implantation in Older Women. Int Urogynecol J (2024). https://doi.org/10.1007/s00192-024-05891-4

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  • DOI: https://doi.org/10.1007/s00192-024-05891-4

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