Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder - A Systematic Review and Meta-analysis

Sep 7, 2026

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Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US and provide a neurostimulation option for overactive bladder (OAB). In the absence of head-to-head trials, this meta-analysis indirectly compared the efficacy and safety of sacral neuromodulation (SNM) and iTNM for OAB. Searches used terms for OAB and neuromodulation. Twenty studies (1416 SNM, 350 iTNM) used single-arm evidence to assess urgency urinary incontinence, OAB response, device-related adverse events, and quality-of-life outcomes.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages26

Reading Time1 h 6 min

AccessFree to download

Abstract

Introduction

Methods

Results

Conclusions

Key Summary Points

Why carry out this study?

What was learned from this study?

Introduction

Adv Ther (2025) 42:10–35 [https://doi.org/10.1007/s12325-024-03019-0](https://doi.org/10.1007/s12325-024-03019-0) REVIEW Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta‑analysis Cindy L. Amundsen · Suzette E. Sutherland · Stephanie J. Kielb · Roger R. Dmochowski Received: August 22, 2024 / Accepted: October 2, 2024 / Published online: October 30, 2024 © The Author(s) 2024 ABSTRACT Introduction: Implantable tibial neuromodulation (iTNM) systems have recently become commercially available in the US, and offer a new method of neurostimulation for the treatment of overactive bladder (OAB). In the absence of headto-head studies, the aim of this meta-analysis was to indirectly compare the efficacy and safety of sacral neuromodulation (SNM) and implantable tibial neuromodulation (iTNM) for the treatment of OAB. Methods: A comprehensive search was performed using terms for OAB and neuromodulation. Supplementary Information The online version contains supplementary material available at [https://doi.org/10.1007/s12325-024-03019-0](https://doi.org/10.1007/s12325-024-03019-0) . C. L. Amundsen (*) Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetricsand Gynecology, Duke University, Durham, NC, USA e-mail: [cindy.amundsen@duke.edu](cindy.amundsen@duke.edu) S. E. Sutherland Arizona Urology Specialists/United Urology Group, Scottsdale, AZ, USA S. J. Kielb Department of Urology, University of Michigan, Ann Arbor, MI, USA R. R. Dmochowski BlueWind Medical, Inc, Park City, UT, USA Primary efficacy measures included a ≥ 50% reduction in urgency urinary incontinence (UUI) episodes, urinary frequency, and/or OAB symptoms. Primary safety measures included the rate of device-related adverse events (AEs). Results: A total of 20 studies met selection criteria, encompassing 1416 patients treated with SNM and 350 patients treated with iTNM. No comparative or placebo-controlled studies for SNM and iTNM were identified, and therefore the analysis was completed using single-arm results. Weighted averages showed that the UUI responder rate was similar for both SNM and iTNM (71.8% and 71.3%, respectively) . Similarly, weighted averages of OAB responder rates were 73.9% for SNM and 79.4% for iTNM. Similar rates of device-related AEs were also observed. Conclusions: This meta-analysis found similar efficacy and safety of SNM and iTNM for the treatment of OAB and UUI, including UUI and OAB symptom response rates, reduction in UUI episodes, significant improvements in quality-oflife (QoL), and low rates of procedure and devicerelated adverse events. Notably, this comparable efficacy was seen without the use of a trial phase of neuromodulation in the iTNM studies versus SNM studies. Keywords: Implantable neurostimulators; Meta-analysis; Systematic review; Urinary bladder; Overactive; Urinary incontinence; Urge; Sacral neuromodulation; Tibialneuromodulation Key Summary Points Why carry out this study? In the past two years, implantable tibial neuromodulation (iTNM) systems have become available in the US, offering a less invasive implantable neuromodulation treatment option for overactive bladder (OAB) and its significant impact on quality of life. This analysis indirectly compares the clinical efficacy and safety of iTNM with sacral neuromodulation (SNM), the most common implantable neuromodulation option for OAB treatment, to provide healthcare providers and patients with additional decisionmaking information. What was learnedfrom this study? This analysis demonstrated that iTNM appears to have similar efficacy and safety to SNM, offering patients with OAB a valuable additional treatment choice. In the future, randomized comparative studies will be important to further establish similarities and differences in efficacy and safety between iTNM and SNM. INTRODUCTION Overactive bladder (OAB) affects million

FAQs

What was the aim of this meta-analysis for OAB treatment?

To indirectly compare the efficacy and safety of sacral neuromodulation (SNM) versus implantable tibial neuromodulation (iTNM) for overactive bladder when no head-to-head studies were available.

How many studies and patients were included, and how was the analysis performed?

Twenty studies met inclusion criteria, covering 1416 patients treated with SNM and 350 treated with iTNM. No comparative or placebo-controlled SNM vs iTNM studies were found, so the meta-analysis relied on single-arm results.

What did the results show about efficacy and safety between SNM and iTNM?

UUI responder rates were similar (71.8% for SNM vs 71.3% for iTNM), and OAB responder rates were comparable (73.9% vs 79.4%). Device-related adverse event rates were also similar, supporting broadly comparable efficacy and safety.

Sep 7, 2026

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