Which researchers or companies are leading efforts to use neuromodulation for urinary incontinence?
Executive summary
Major clinical and commercial leaders in neuromodulation for urinary incontinence include long-established sacral neuromodulation practice and device makers and a wave of newer companies developing percutaneous or pudendal stimulators. Sacral neuromodulation (SNM) is an established therapy used in over 300,000 patients worldwide and is recommended for refractory overactive bladder and fecal incontinence [1]. Recent commercial activity includes FDA clearance for an integrated percutaneous sacral neuromodulation system reported in 2025 and investigational programs such as Amber‑UI (pudendal) and other next‑gen devices noted in industry pipeline reviews [2] [3].
1. The incumbent: sacral neuromodulation as clinical standard
Sacral neuromodulation (SNM) has been practiced for decades, with origins in the 1980s and FDA approval in 1997; clinical reviews describe SNM as “well‑established, safe, effective, and minimally invasive” for refractory overactive bladder, urgency urinary incontinence and some neurogenic bladder presentations [1]. Clinical guidelines and single‑center cohort reports continue to frame SNM as a durable treatment option for refractory overactive bladder and urinary retention [4] [1].
2. Device makers in the headlines: regulatory wins and new entrants
Commercial momentum accelerated in 2025 when regulators approved an “integrated sacral neuromodulation system” for urinary urge incontinence, based on the SANS‑UUI pivotal trial and promoted by Neuspera Medical in industry reporting [2]. Industry analyses and urology trade coverage also flag that the first three quarters of 2025 saw at least one major approval for an integrated SNM system, signaling active competition and evolving hardware [5] [2].
3. Next‑gen targets: pudendal and percutaneous systems
Researchers and companies are exploring alternative nerve targets and form factors to address limits of SNM. The Amber‑UI® therapy — described as an implantable, “adaptive” pudendal neuromodulation system — has been tested for safety and feasibility in early studies and was highlighted as a novel approach in reviews of future neuromodulation advancements [3]. Percutaneous, battery‑free miniaturized systems have also been presented in trials (SANS‑UUI) and reported as milestone innovations in 2025 coverage [2] [6].
4. Academic centers and clinical adopters: hospitals offering newer devices
Major academic urology and urogynecology programs remain active adopters and clinical evaluators of new neuromodulation offerings; for example, Johns Hopkins highlighted a new patient‑controlled neuromodulation device option in its clinical program in 2025, emphasizing practical, outpatient‑friendly alternatives to surgery [7]. Leading hospitals such as NYU Langone and UChicago Medicine continue to describe SNM as a go‑to third‑line therapy and offer implant programs, showing the academic conduit between trials and patient care [8] [9].
5. The research base: trials, protocols, and pipeline reports
Randomized protocols and feasibility trials are active worldwide. A 2025 randomized controlled trial protocol in Spain tests peripheral tibial nerve stimulation combined with therapeutic exercise, demonstrating academic interest in non‑implant peripheral neuromodulation [10]. Industry pipeline analyses project a robust expansion of next‑generation neuromodulation devices alongside pharmacologic and regenerative strategies for overactive bladder [11].
6. Efficacy, uptake, and unresolved questions
Published figures show broad effectiveness but variable response rates: some practice summaries report 70–85% symptom relief with sacral neurostimulation in selected cohorts, while older systematic reports list cure/improvement ranges for pelvic floor neuromodulation of roughly 30–90% depending on modality and outcome measure [12] [13]. Long‑term superiority over conservative options such as pelvic‑floor training remains debated in older literature, and current reporting emphasizes that innovations aim to reduce morbidity, improve targeting, and expand candidacy [13] [6].
7. What sources emphasize and what they leave out
Academic reviews and specialty society reports stress SNM’s established status and newer device feasibility studies, with industry press and trade outlets highlighting regulatory approvals—Neuspera’s SANS‑UUI results being cited as pivotal in 2025 coverage [1] [2]. Available sources do not mention specific venture investors, comprehensive head‑to‑head trial outcomes comparing all new entrants, or detailed long‑term comparative safety data for the newest percutaneous and pudendal implants; those gaps matter for clinicians and patients weighing options [2] [3].
Bottom line: sacral neuromodulation remains the clinical backbone with major academic and hospital programs delivering care, while a new generation of companies (percutaneous, battery‑free, and pudendal systems) led by commercial entrants such as Neuspera and investigational platforms like Amber‑UI are actively pushing approvals and early trials in 2024–2025 [1] [2] [3].