Sacral Neuromodulation Still Seen as OAB Gold Standard in Review

Sacral neuromodulation (SNM) is still considered the gold standard neuromodulation option for refractory overactive bladder (OAB), according to a narrative review in Autonomic Neuroscience: Basic and Clinical.¹ Tibial nerve stimulation serves as a less invasive second- or third-line option, while peroneal, pudendal, and transcranial magnetic stimulation remain experimental.

Investigators from the University of Rome Tor Vergata searched PubMed, Scopus, and EMBASE for studies from the past decade. They noted that antimuscarinics are often limited by adverse effect-related discontinuation and β3-adrenergic agonists by moderate efficacy and possible cardiovascular risks, making neuromodulation a second- or third-line option for patients who do not respond. Guidelines recommend SNM and percutaneous tibial nerve stimulation (PTNS) as second-line (European Association of Urology) and third-line (American Urological Association) options, alongside onabotulinumtoxinA.

Tibial Nerve Stimulation Outperformed Placebo and Tolterodine

In a randomized, double-blind, placebo-controlled trial, 12 of 17 patients with detrusor overactivity incontinence (71%) who received PTNS were responders, vs none of 15 on placebo (P < .001).^1,2 In the OAB Innovative Therapy trial, PTNS efficacy was 79.5% vs 54.8% for tolterodine (Detrol; Pfizer; P = .01).¹

In a randomized trial of 120 patients, transcutaneous tibial nerve stimulation (TTNS) and PTNS both significantly reduced symptoms, but TTNS offered home administration and fewer adverse events (5% vs 15%). A home-based TTNS device, TENSI+, reported a 67% success rate at 3 months in a postmarket study. The review does not define success or report a comparator.

In the French multicenter SOUNDS (NCT02186041) registry, 72% of patients had at least a 50% improvement in urgency urinary incontinence at 3 years, declining to 68% at 5 years. Revision and removal rates rose from 33% and 13% at 3 years to 39% and 15% at 5 years.

The review reported that in the ROSETTA (NCT01502956) trial of 386 women with refractory urgency urinary incontinence, SNM and onabotulinumtoxinA (Botox; AbbVie) produced no significant difference in symptom improvement at 2 years. Patients reported higher satisfaction with onabotulinumtoxinA, which carried a higher rate of recurrent urinary tract infection (24% vs 10%), while SNM had a 9% removal rate and a 3% revision rate.

A network meta-analysis of 21 randomized trials with 1433 patients found SNM superior to PTNS for reducing urgency and frequency episodes, while PTNS and TTNS were more effective for urgency incontinence.

Peroneal Stimulation Comparable to Solifenacin by Week 8

Peroneal nerve stimulation reduced urgency episodes by 50% or more in 86% of patients at week 4 and 79% at week 7. In a randomized comparison of 77 patients, solifenacin 5 mg (Vesicare; Astellas Pharma US) produced a faster initial response (P = .009), but peroneal stimulation provided comparable symptom relief by week 8 and better quality-of-life scores. The review identified no studies comparing peroneal stimulation with PTNS or SNM and called pudendal and transcranial magnetic stimulation investigational.

The review highlighted machine learning models built from ROSETTA data that predicted response with an area under the curve, a measure of predictive accuracy, of 0.95 for onabotulinumtoxinA and 0.88 for SNM. The authors said AI could also help build closed-loop systems that adjust treatment using real-time physiological feedback, a step toward more personalized care.

The authors listed surgical implantation and cost as barriers to SNM use and frequent sessions and limited coverage as drawbacks of PTNS. They noted that mid- and long-term outcomes for TENSI+ are not yet available.

References

1. Rosato E, Di Rocco F, Cerrelli G, Mollo L, Bianchi D, Finazzi Agrò E. Neuromodulation techniques for managing overactive bladder. Auton Neurosci. 2026;266:103439. doi:10.1016/j.autneu.2026.103439
2. Finazzi-Agrò E, Petta F, Sciobica F, Pasqualetti P, Musco S, Bove P. Percutaneous tibial nerve stimulation effects on detrusor overactivity incontinence are not due to a placebo effect: a randomized, double-blind, placebo controlled trial. J Urol. 2010;184(5):2001-2006. doi:10.1016/j.juro.2010.06.113