OAB / Urinary Incontinence Treatment Updates (2025–2026)
- Catherine Song, PhD.
- Feb 10
- 5 min read
Updated: Mar 6
At a Glance
Gemtesa became the first β3-agonist approved for men with OAB + BPH (Dec 2024)
Battery-free sacral neuromodulation (Neuspera) approved with 84% responder rate
Three implantable tibial neuromodulation platforms are now available
2024 AUA/SUFU guideline eliminates step therapy in favor of shared decision-making
CMS reimbursement is improving, including 40% ASC increase for iTNM
Digital bladder diaries are increasingly recognized for better adherence and outcomes
What Changed in OAB/UI Management Over the Last 18 Months?
The past 18 months have brought significant innovation to overactive bladder (OAB) and urinary incontinence (UI) management.
Key areas of change include:
Clinical guidelines
Pharmacotherapy approvals
Neuromodulation technologies
Reimbursement and coverage
Digital health adoption
Industry consolidation
Executive Summary
Pharmacotherapy: Gemtesa becomes the first β3-agonist approved for men with OAB+BPH (Dec 2024)
Neuromodulation - Sacral: Neuspera's battery-free iSNM system approved (June 2025) with an 84% responder rate
Neuromodulation - Tibial: Three distinct iTNM platforms now available: Medtronic ALTAVIVA (automatic therapy), BlueWind REVI (patient-controlled, 40% CMS reimbursement increase), Valencia eCoin (acquired by Boston Scientific)
Clinical Guidelines: 2024 AUA/SUFU guideline eliminates step therapy in favor of a shared decision-making approach
Digital Health: Growing evidence supports digital bladder diaries for improved patient adherence and data-driven care
Industry Consolidation: Boston Scientific acquires Axonics ($3.7B) + Valencia, positioning as a dominant neuromodulation player
Permanent Retention: VesiFlow inFlow receives CMS national pricing (Jan 2026) for catheter-free bladder emptying
Clinical Practice Paradigm Shift
What Changed in the 2024 AUA/SUFU OAB Guideline?
Published: April 2024
The AUA and SUFU released a transformative guideline update that fundamentally changes treatment planning for OAB.
Key change
Rigid stepwise therapy is replaced by shared decision-making and personalized treatment selection.
Treatments are presented as a “menu,” not sequential steps, with patient preferences and lifestyle driving therapy choice.
Earlier use of advanced therapies may be appropriate for individual patients based on shared decision-making.
Expanded scope
Now includes the impact of non-urological factors (obesity, constipation, medical comorbidities).
Emphasizes patient-reported outcomes as critical to management.
Pharmacotherapy Update
What Is New in Drug Therapy for OAB + BPH?
Gemtesa® (Vibegron) – First β3-Agonist for OAB+BPH
FDA approval: December 18, 2024
First and only β3-adrenergic receptor agonist approved for men with OAB symptoms receiving BPH pharmacologic therapy.
Pivotal trial (COURAGE) demonstrated statistically significant reductions in micturition and urgency episodes with favorable tolerability.
Addresses a critical treatment gap for men with persistent OAB despite alpha-blocker or 5-ARI treatment.
Neuromodulation: Major Advances
Sacral Neuromodulation (SNM)
Neuspera® iSNM System - Battery-Free SNM
FDA Approval: June 18, 2025
First integrated sacral neuromodulation system eliminates implanted batteries entirely.
Miniaturized neurostimulator paired with an external wireless disc worn for about 2 hours daily at the lower back.
No battery replacement surgeries required.
Clinical results (SANS-UUI trial)
84% responder rate.
42% achieved complete dryness.
Implantable Tibial Neuromodulation (iTNM)
Medtronic ALTAVIVA™
FDA Approval: September 19, 2025
Implanted near the ankle with therapy activated immediately post-procedure.
Automatic therapy delivery - no daily patient intervention required.
500+ physicians trained since launch.
BlueWind Medical REVI® Enhanced Wearable
FDA Clearance: December 16, 2025
Patient-controlled therapy via external ankle wearable (30 min, 1-2x daily).
79% responder rate, 97% patient satisfaction at 2 years.
40% CMS reimbursement increase in ASC setting (CPT 0817T: $19,839).
Only iTNM device approved without mandating prior conservative therapy failure.
Valencia eCoin®
Acquired by Boston Scientific: January 12, 2026
Coin-sized leadless implant with automatic tibial nerve stimulation.
68% responder rate in pivotal trial.
Boston Scientific acquisition signals major strategic investment in iTNM.
Industry Consolidation
Boston Scientific
- Acquired Axonics ($3.7B, Nov 2024) and Valencia Technologies (Jan 2026), positioning as a dominant player across SNM and iTNM spectrum.
Medtronic
- First company with a complete SNM + iTNM portfolio; 500+ physicians trained on ALTAVIVA in the first 3 months.
What Does This Mean for Clinical Practice?
Treatment Selection: The 2024 AUA/SUFU guideline formally endorses a personalized approach over step therapy. iTNM offers an intermediate option between conservative therapy and SNM. Battery-free technologies address patient concerns about revision surgeries. Patient preference drives choice: automatic therapy (ALTAVIVA) vs. patient-controlled (REVI) vs. passive (eCoin).
Reimbursement: CMS increasingly recognizes neuromodulation value with favorable payment adjustments (40% ASC increase for REVI signals broader iTNM acceptance).
Pharmacotherapy: Gemtesa fills the treatment gap for men with OAB+BPH receiving alpha-blocker or 5-ARI therapy.
Permanent Urinary Retention
Vesiflo inFlow™ Voiding Prosthesis
CMS national pricing: November 12, 2024
Effective: January 1, 2026
National pricing established for physician CPT procedure codes.
Ensures consistent nationwide coverage.
First catheter-free solution for women with permanent urinary retention due to neurological conditions (MS, SCI, spina bifida, MSA).
Clinical outcomes
Fewer UTIs.
Improved quality of life compared to clean intermittent catheterization.
Digital Health & Patient Monitoring
The 2024 AUA/SUFU guideline emphasizes patient-reported outcomes as critical to OAB management. Digital bladder diary applications improve patient adherence and data completeness compared to paper diaries, enabling more accurate symptom tracking and data-driven treatment decisions.
Tools like Bladderly leverage smartphone technology to streamline voiding diary collection while reducing patient burden.
Looking Ahead
Key developments to watch in 2026:
Real-world implementation of the shared decision-making framework from the 2024 guideline.
Comparative effectiveness data between iTNM platforms.
Long-term durability and revision rates for battery-free technologies.
Combination therapy strategies (pharmacotherapy + neuromodulation).
Digital health integration for remote monitoring and patient-reported outcomes collection.
Patient-reported outcomes research aligned with guideline emphasis.
Additional market entrants and technology refinements.
The urology community has more evidence-based options than ever to offer patients with OAB and UUI. The 2024 AUA/SUFU guideline's endorsement of shared decision-making, combined with rapid technological innovation and favorable reimbursement trends, enables truly personalized treatment pathways aligned with patient preferences, lifestyle, and clinical needs.
This educational update is provided by the team at Soundable Health. We're committed to supporting the urology community with timely, evidence-based clinical information.
[1] Neuspera Medical, Inc. (2025, June 18). Neuspera Medical receives FDA approval for the first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence. PR Newswire.
[2] Medtronic plc. (2025, September 19). Medtronic secures FDA approval for the Altaviva™ device for urge urinary incontinence. PR Newswire.
[3] BlueWind Medical, Ltd. (2025, December 16). BlueWind Medical receives FDA 510(k) clearance for enhanced Revi® wearable supporting long-term treatment of urgency urinary incontinence. Business Wire.
[4] Sumitomo Pharma America, Inc. (2024, December 23). U.S. FDA approves GEMTESA® (vibegron) for men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. PR Newswire.
[5] American Urological Association, & Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction. (2019). Overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. American Urological Association.
[6] American College of Obstetricians and Gynecologists. (2015/2025). Practice Bulletin No. 210: Urinary incontinence in women. Obstetrics & Gynecology. (Reaffirmed 2025).
[7] Heesakkers, J. P. F. A., et al. (2025). Two-year efficacy and safety outcomes of the pivotal OASIS trial using the Revi® system for treatment of urgency urinary incontinence. Journal of Urology, 213(3), 323–332.
[8] Padron, O., et al. (2025). Six-month results from the SANS-UUI trial of an ultra-miniaturized sacral neuromodulation system. Abstract 46. Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) Winter Meeting.
[9] Staskin, D., Frankel, J., Varano, S., et al. (2020). International phase III randomized, double-blind, placebo- and active-controlled study to evaluate the efficacy and safety of vibegron in patients with overactive bladder (EMPOWUR). Journal of Urology, 204(2), 316–324.
[10] Staskin, D., Owens-Grillo, J., Thomas, E., et al. (2024). Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men receiving pharmacological therapy for benign prostatic hyperplasia: Results from the phase III COURAGE trial. Journal of Urology, 212(2), 256–266.
[11] MacDiarmid, S. A., Peters, K. M., Chen, A., et al. (2021). Pivotal study of leadless tibial nerve stimulation with eCoin® for urgency urinary incontinence: An open-label, single-arm trial. Journal of Urology, 206(5), 1099–1107.