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Background <p>Overactive bladder (OAB) is commonly managed with antimuscarinic agents, although tolerability limits long-term adherence. Tibial nerve stimulation (TNS) has emerged as a non-pharmacologic alternative. This study compared the efficacy and safety of TNS versus solifenacin in women with OAB.</p> Methods <p>In this randomized controlled clinical trial, 118 patients met OAB diagnostic criteria, who presented to Qaem Hospital (Mashhad, Iran, 2023). Participants were randomly assigned to receive 12 weeks of either TNS (two 30-minute sessions weekly) or oral solifenacin (5&#xa0;mg daily). Primary outcomes included changes in OAB symptom severity, urinary incontinence, and quality of life scores, using validated questionnaires at baseline and week 12. Statistical analysis was conducted using SPSS version 22, with significance set at <i>p</i> &lt; 0.05.</p> Results <p>Both treatments led to significant improvement in OAB symptoms, urinary incontinence severity, and quality of life (all <i>p</i> &lt; 0.001). TNS produced slightly greater improvement in OAB symptom severity (<i>p</i> = 0.016) and significantly greater reduction in urinary incontinence severity (<i>p</i> = 0.015). Quality of life improved substantially in both groups (<i>p</i> &lt; 0.001), with comparable post-treatment scores. Adverse effects occurred in 88.1% of solifenacin users, whereas no side effects were reported with TNS.</p> Conclusion <p>TNS is an effective and well-tolerated treatment for OAB, offering superior improvement in urinary incontinence and a markedly better safety profile compared with solifenacin. TNS may represent a preferable non-pharmacologic alternative for patients who cannot tolerate or do not respond adequately to anticholinergic medications. Future studies with larger cohorts and extended follow-up durations would be beneficial to validate and expand upon our findings.</p> Trial registration <p>The study protocol was officially registered in the Iranian Registry of Clinical Trials under the identifier IRCT20190618043934N25 on 2024-05-13.</p>

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Comparative efficacy of transcutaneous tibial nerve stimulation (TTNS) versus solifenacin in female patients with overactive bladder

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月17日

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  • MohammadJavad Safaie Yazdi,
  • Salman Nazary-Moghadam,
  • Bagher Soleimani,
  • Seyyed Parham Ahmadi,
  • Fatemeh Sadabadi,
  • Zhila Sheikhi

摘要

Background

Overactive bladder (OAB) is commonly managed with antimuscarinic agents, although tolerability limits long-term adherence. Tibial nerve stimulation (TNS) has emerged as a non-pharmacologic alternative. This study compared the efficacy and safety of TNS versus solifenacin in women with OAB.

Methods

In this randomized controlled clinical trial, 118 patients met OAB diagnostic criteria, who presented to Qaem Hospital (Mashhad, Iran, 2023). Participants were randomly assigned to receive 12 weeks of either TNS (two 30-minute sessions weekly) or oral solifenacin (5 mg daily). Primary outcomes included changes in OAB symptom severity, urinary incontinence, and quality of life scores, using validated questionnaires at baseline and week 12. Statistical analysis was conducted using SPSS version 22, with significance set at p < 0.05.

Results

Both treatments led to significant improvement in OAB symptoms, urinary incontinence severity, and quality of life (all p < 0.001). TNS produced slightly greater improvement in OAB symptom severity (p = 0.016) and significantly greater reduction in urinary incontinence severity (p = 0.015). Quality of life improved substantially in both groups (p < 0.001), with comparable post-treatment scores. Adverse effects occurred in 88.1% of solifenacin users, whereas no side effects were reported with TNS.

Conclusion

TNS is an effective and well-tolerated treatment for OAB, offering superior improvement in urinary incontinence and a markedly better safety profile compared with solifenacin. TNS may represent a preferable non-pharmacologic alternative for patients who cannot tolerate or do not respond adequately to anticholinergic medications. Future studies with larger cohorts and extended follow-up durations would be beneficial to validate and expand upon our findings.

Trial registration

The study protocol was officially registered in the Iranian Registry of Clinical Trials under the identifier IRCT20190618043934N25 on 2024-05-13.