Efficacy and safety of an implantable tibial neuromodulation system for overactive bladder with urgency urinary incontinence: an open-label, single arm trial - Report - MDSpire

Efficacy and safety of an implantable tibial neuromodulation system for overactive bladder with urgency urinary incontinence: an open-label, single arm trial

  • By

  • Fuyuan Zheng

  • Yongjun Guan

  • Weilin Fang

  • Tingting Lv

  • Jin Huang

  • Xin Song

  • Jianwei Lv

  • July 15, 2026

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Clinical Report: Assessment of Safety and Effectiveness of iTNS for OAB

Overview

This study evaluates the safety and efficacy of an implantable tibial neuromodulation system (iTNS) for treating overactive bladder (OAB) with urgency urinary incontinence (UUI).

Background

Overactive bladder (OAB) is a prevalent condition that significantly impacts quality of life. Traditional treatments have limitations, and third-line options like tibial neuromodulation offer a minimally invasive alternative.

Data Highlights

Outcome6 Months
Response Rate (≥50% reduction in UUI episodes)90% (9/10 patients)
Consecutive Dry Days40% (4/10 patients)
UUI Episodes per Day3.235 to 0.632
OAB-Q Score Improvement69.5 to 44.4
OABSS Score Improvement9 to 6.2
Patient Satisfaction80%

Key Findings

  • 90% response rate at 6 months.
  • 40% of participants experienced ≥3 consecutive dry days.
  • UUI episodes per day decreased from 3.235 to 0.632.
  • OAB-Q scores improved from 69.5 to 44.4.
  • 80% of patients reported satisfaction at 6 months.

Clinical Implications

The iTNS system shows efficacy in reducing UUI symptoms in patients with OAB.

Conclusion

The iTNS system is effective for managing UUI in OAB patients.

Related Resources & Content

  1. Techniques in Coloproctology, 2025 -- Efficacy of Sacral Neuromodulation Using Ultra-Low Stimulation for Treating Faecal Incontinence
  2. Techniques in Coloproctology, 2024 -- Impact of External Neuromuscular Electrical Stimulation on Women Experiencing Urgency Urinary Incontinence
  3. Techniques in Coloproctology, 2025 -- Bilateral Stimulation of the Posterior Tibial Nerve as a Neuromodulatory Approach for Obstructed Defecation
  4. EAU Guidelines on Non-neurogenic Female LUTS - DISEASE MANAGEMENT, 2026
  5. Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis, PMC
  6. Prolonged Transcutaneous Tibial Nerve Stimulation for Pediatric Overactive Bladder: A Six-Month Prospective Single-Group Investigation
  7. eCoin Peripheral Neurostimulator – P200036 | FDA
  8. Three-year efficacy and safety of Revi® implantable tibial neuromodulation from the pivotal OASIS study
  9. EAU Guidelines on Non-neurogenic Female LUTS - DISEASE MANAGEMENT
  10. Sacral and Implantable Tibial Neuromodulation for the Management of Overactive Bladder: A Systematic Review and Meta-analysis - PMC
  11. Impact of Revi® Implantable Tibial Neuromodulation on Quality of Life in Patients with Urgency Urinary Incontinence | International Urogynecology Journal | Springer Nature Link
  12. PD24-15 SAFETY OF THE ECOIN IMPLANTABLE TIBIAL NERVE STIMULATOR – AN INTERIM ANALYSIS OF CLINICAL DATA AND REAL-WORLD EXPERIENCE | Journal of Urology
  13. Two-Year Efficacy and Safety Outcomes of the Pivotal OASIS Study Using the Revi System for Treatment of Urgency Urinary Incontinence - PubMed

Original Source(s)

Efficacy and safety of an implantable tibial neuromodulation system for overactive bladder with urgency urinary incontinence: an open-label, single arm trial

  • by Fuyuan Zheng, Yongjun Guan, Weilin Fang, Tingting Lv, Jin Huang, Xin Song, Jianwei Lv

  • July 15, 2026

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