Introduction

The “first-line” interventions for the treatment of overactive bladder (OAB) encompass non-invasive options such as dietary modifications, pelvic floor electrical stimulation etc. However, due to inconsistent results, these have to be combined with OAB medications. There are safety concerns with the long-term use of anticholinergics. Minimally invasive procedures such as percutaneous and implantable tibial nerve stimulation, sacral neuromodulation (SNM) have reported good efficacy and high patient satisfaction.  The new implantable tibial neuromodulation (iTNM) systems have become commercially available in the US, which are less invasive than the currently available SNM. However, there are no studies that compare the two modalities.

Aim

To indirectly compare the similarities and differences in patient outcomes undergoing SNM and iTNM for the treatment of OAB, since there are no head-to-head studies

Method

Study Design

• Systematic literature review and meta-analysis

Treatment Strategy

• A comprehensive literature search was conducted to identify studies that evaluated the safety and efficacy of SNM and iTNM for the treatment of OAB and/or urgency urinary incontinence (UUI)
• Key inclusion criteria included permanent implantation of SNM or iTNM, prospective or retrospective studies, or randomized trial with >15 patients and adult patient population
• Weighted averages were calculated for the primary efficacy and safety measures

  Endpoints

  Primary Efficacy Outcomes

• A ≥ 50% reduction in urgency urinary incontinence (UUI) episodes, urinary frequency, and/or OAB symptoms

  Primary Safety Outcomes

• Incidence of device-related adverse events (AEs)

Results

• The meta-analysis included 20 studies with 1766 patients; 1416 patients treated with SNM, and 350 patients treated with iTNM
• Single-arm results were considered as there were no comparative or placebo-controlled studies for SNM and iTNM
• At baseline, UUI was prevalent in majority of these patients; weighted average of 98.9% for iTNM and 83.3% for SNM
• Weighted average number of UUI episodes were similar at baseline
• UUI responder rate was similar for both SNM and iTNM (71.8% and 71.3%, respectively)
• OAB response rates were also similar; weighted averages demonstrated OAB responder rates of 73.9% for SNM and 79.4% for iTNM
• Assessment of health-related quality-of-life (HRQoL) scores revealed an average increase of 34.5 points for iTNM and 35.1 points for SNM
• Higher proportion of patients reported higher patient global impression of improvement ( PGI-I) score with iTNM; 88.5% vs 74.9%
• Safety profile of both devices was good with similar rates of device-related AEs weighted average of 9.6% vs 12.7% for iTNM and SNM respectively

Conclusion

• The comparable efficacy of sacral neuromodulation and implantable tibial neuromodulation for the treatment of overactive bladder was noted without the use of a trial phase of neuromodulation in the iTNM studies vs SNM studies
• Both the devices had similar UUI and OAB symptom response rates, reduction in UUI episodes, notable improvements in QoL, with low rates of procedure and device-related adverse events

Adv Ther. 2025;42:10-35. Doi: 10.1007/s12325-024-03019-0.