植入式胫神经刺激系统治疗老龄难治性OAB有效性的初步探索

Efficacy of implantable tibial nerve stimulation system in the treatment of refractory overactive bladder among geriatric patients

摘要

目的 初步评估植入式胫神经刺激（iTNS）系统治疗老龄中重度难治性膀胱过度活动症（OAB）的临床有效性、安全性和器械可用性。方法 前瞻性分析2025-2026年在北京医院泌尿外科接受iTNS系统治疗的5例老龄中重度难治性OAB患者的临床资料。术中均在下肢高频超声引导下精确定位胫神经并植入刺激电极。主要结局指标为OAB症状评分量表（OABSS）总分及72 h排尿日记中日均排尿频次较基线的变化;次要结局指标为感知膀胱症状量表（PPBC-S）评分、夜尿症生活质量量表（N-QoL）评分、尿急及尿失禁分项评分、平均单次尿量和设备使用体验;安全性指标包括围手术期及随访期间局部和器械相关不良事件。结果 5例患者均顺利完成电极植入手术。超声影像可清晰分辨胫后动静脉及紧邻的胫神经。随访期间，多数患者的OAB相关症状（尿急、尿频、急迫性尿失禁）较基线均有不同程度的改善。其中3例患者在术后改善明显，末次随访时其OABSS总分分别由基线的11分、12分、13分降至1分（12周）、4分（12周）和3分（4周），日均排尿频次分别由8.7次、11.3次、7.7次减少至5.0次、7.0次、7.0次，且N-QoL评分显著提升。1例患者改善效果中等，术后4周虽OABSS总分未变（11分），但主观困扰（PPBC-S评分）由5分降至2分，日均排尿频次降至6.7次。1例患者疗效局限，12周时OABSS评分由14分仅微降至12分。安全性方面，仅1例患者在术后早期出现局部轻度肿胀、疼痛及异物感，数日后自行缓解，未发生严重器械相关不良事件或切口感染。结论 高频超声引导下iTNS系统治疗老龄中重度难治性OAB显示出良好的初步疗效，操作便捷性及患者满意度均较高，但其长期疗效与安全性仍有待大样本、多中心临床试验进一步验证。

Abstract

Objective To preliminarily evaluate the clinical efficacy, safety and device usability of the implantable tibial nerve stimulation (iTNS) system in the treatment of moderate to severe overactive bladder (OAB). Methods A prospective analysis was performed on the clinical data of 5 geriatric patients with moderate to severe refractory OAB who underwent iTNS system implantation at Beijing Hospital during 2025 and 2026. During the procedure, the tibial nerve was precisely located under high-frequency ultrasound guidance in the lower limb, and the stimulation electrode was implanted accordingly. The primary outcomes included changes from baseline in total overactive bladder symptom score (OABSS) and average daily voiding frequency based on 72-hour voiding diaries. Secondary outcomes included perception of bladder condition score (PPBC-S), nocturia quality of life questionnaire (N-QoL), urgency and incontinence subscores, mean voided volume and device usability. Safety outcomes included local and device-related adverse events during the perioperative and follow-up periods. Results All 5 patients successfully completed the electrode implantation procedure. High-frequency ultrasound clearly visualized the posterior tibial arteries, veins and the adjacent tibial nerves. During the follow-up, OAB-related symptoms (urinary urgency, frequency and urge urinary incontinence) improved to varying degrees in most patients compared with baseline. Three patients achieved remarkable improvement: at the last follow-up, their total OABSS decreased from 11, 12 and 13 points at baseline to 1 (12 weeks), 4 (12 weeks) and 3 (4 weeks) respectively. Their average daily voiding frequency reduced from 8.7, 11.3 and 7.7 times to 5.0, 7.0 and 7.0 times respectively, with a significant elevation in N-QoL scores. One patient had moderate improvement: at week 4 postoperatively, the total OABSS remained unchanged (11 points), but the subjective distress (PPBC-S score) dropped from 5 to 2 points, and daily voiding frequency decreased to 6.7 times. One elderly patient had limited therapeutic response, with OABSS slightly declining from 14 to 12 points at week 12. For safety outcomes, only 1 patient developed mild local swelling, pain and foreign body sensation in the early postoperative stage, which resolved spontaneously within days; no severe device-related adverse events or incision infections occurred. Conclusion The iTNS system guided by high-frequency ultrasound presents favorable efficacy for moderate to severe refractory OAB in geriatric patients, with simple operation and high patient satisfaction. However, its long-term efficacy and safety remain to be verified by large-sample, multicenter clinical trials.

关键词

膀胱过度活动症 / 植入式胫神经刺激 / 超声引导

Key words

overactive bladder / implantable tibial nerve stimulation / ultrasound guidance

参考文献

[1] EUROPEAN ASSOCIATION OF UROLOGY. EAU guidelines on the diagnosis and management of female non-neurogenic lower urinary tract symptoms. Part 1: diagnostics, overactive bladder, stress urinary incontinence, and mixed urinary incontinence[J]. Eur Urol, 2022, 82(1): 49-59.

[2] CAMERON AP, CHUNG DE, DIELUBANZA EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder[J]. J Urol, 2024, 212(1): 11-20.

[3] KAPUR A, AALAMI HARANDI A, HARTMAN-KENZLER J, et al. Shifts in patient preference of third-line overactive bladder therapy after introduction of the implantable tibial nerve stimulator[J]. Neurourol Urodyn, 2024, 43(4): 959-966.

[4] 王建业， 许克新， 谢克基， 等. 膀胱过度活动症诊断治疗指南//黄健，张旭，魏强， 等. 中国泌尿外科和男科疾病诊断治疗指南（2022版）[M]. 北京: 科学出版社， 2022: 523-527.

[5] YAMASHIRO J, DE RIESE W, DE RIESE C. New implantable tibial nerve stimulation devices: review of published clinical results in comparison to established neuromodulation devices[J]. Res Rep Urol, 2019, 11: 351-357.

[6] 万小萍. 可植入式胫神经刺激器治疗膀胱过度活动症的研究进展[J]. 临床泌尿外科杂志， 2022，37（2）: 150-155.

[7] SMITH AL. Implantable tibial nerve stimulation (iTNS): opportunities and challenges[J]. J Urol, 2026, 215(6): 667-669.

[8] 周文倩， 江文瑞， 刘玉杰， 等. 膀胱过度活动症的神经调控及与情绪关联性的机制[J]. 神经解剖学杂志， 2024，40（6）: 768-772.

[9] PEYRONNET B, MIRONSKA E, CHAPPLE C, et al. A comprehensive review of overactive bladder pathophysiology: on the way to tailored treatment[J]. Eur Urol, 2019, 75(6): 988-1000.

[10] GAZIEV G, TOPAZIO L, IACOVELLI V, et al. Percutaneous tibial nerve stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review[J]. BMC Urol, 2013, 13: 61.

[11] PETERS KM, CARRICO DJ, PEREZ-MARRERO RA, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial[J]. J Urol, 2010, 183(4): 1438-1443.

[12] HANYU-DEUTMEYER A, PRITZLAFF SG. Peripheral nerve stimulation for the 21st century: sural, superficial peroneal, and tibial nerves[J]. Pain Med, 2020, 21(Suppl 1): S64-S67.

[13] HUNTOON MA, HUNTOON EA, OBRAY JB, et al. Feasibility of ultrasound-guided percutaneous placement of peripheral nerve stimulation electrodes in a cadaver model: part one, lower extremity[J]. Reg Anesth Pain Med, 2008, 33(6): 551-557.

基金资助

北京“高创计划”-青年人才托举工程项目(BJ-2025-371)