Department of Urology, China Rehabilitation Research Centre, China Rehabilitation Science Institute, Rehabilitation School of Capital Medical University, Beijing, China.
University of Health and Rehabilitation Sciences, Qingdao, Shandong, China.
BJU Int. 2024 Jun;133(6):760-769. doi: 10.1111/bju.16330. Epub 2024 Mar 11.
To evaluate the efficacy and safety of a wearable, smartphone-controlled, rechargeable transcutaneous tibial nerve stimulation (TTNS) device in patients with overactive bladder (OAB).
This multicentre, prospective, single-blind, randomised clinical trial included eligible patients with OAB symptoms who were randomly assigned to the stimulation group or sham group. The primary efficacy outcome was change from baseline in voiding frequency/24 h after 4 weeks of treatment. The secondary efficacy outcomes included changes in bladder diary outcomes (urgency score/void, nocturia episodes/day, micturition volume/void, and incontinence episodes/day), questionnaires on Overactive Bladder Symptom Score (OABSS), Patient Perception of Bladder Condition (PPBC), and American Urological Association Symptom Index Quality of Life Score (AUA-SI-QoL) at baseline and after 4 weeks of treatment. Device-related adverse events (AEs) were also evaluated.
In the full analysis set (FAS), the mean (sd) change of voiding frequency/24 h in the stimulation group and sham group at 4 weeks were -3.5 (2.9) and -0.6 (2.4), respectively (P < 0.01). Similar results were obtained in the per-protocol set (PPS): -3.5 (2.9) vs -0.4 (2.3) (P < 0.01). In the FAS and PPS, micturition volume/void significantly improved at 4 weeks (P = 0.01 and P = 0.02). PPBC improvement almost reached significance in the FAS (P = 0.05), while it was significant in the PPS (P = 0.02). In the FAS and PPS, AUA-SI-QoL significantly improved at 4 weeks in the two groups (P < 0.01 and P < 0.01), whereas there were no significant differences in urgency score/void, nocturia episodes/day or OABSS between the groups. Also, no device-related serious AEs were reported.
The non-invasive neuromodulation technique using the novel ambulatory TTNS device is effective and safe for treating OAB. Its convenience and easy maintenance make it a new potential home-based treatment modality. Future studies are warranted to confirm its longer-term efficacy.
评估一种可穿戴、智能手机控制、可充电的经皮胫神经刺激（TTNS）设备在膀胱过度活动症（OAB）患者中的疗效和安全性。
这项多中心、前瞻性、单盲、随机临床试验纳入了符合条件的 OAB 症状患者，他们被随机分配到刺激组或假刺激组。主要疗效终点是治疗 4 周后，与基线相比，排尿频率/24 小时的变化。次要疗效终点包括膀胱日记结果（尿急评分/排尿、夜间排尿次数/天、排尿量/次和失禁次数/天）、OAB 症状评分（OABSS）、患者对膀胱状况的感知（PPBC）和美国泌尿协会症状指数生活质量评分（AUA-SI-QoL）的变化，分别在基线和治疗 4 周后进行评估。还评估了与设备相关的不良事件（AE）。
在全分析集（FAS）中，刺激组和假刺激组在治疗 4 周时的平均（标准差）排尿频率/24 小时变化分别为-3.5（2.9）和-0.6（2.4）（P<0.01）。在符合方案集（PPS）中也得到了类似的结果：-3.5（2.9）与-0.4（2.3）（P<0.01）。在 FAS 和 PPS 中，排尿量/次在 4 周时显著改善（P=0.01 和 P=0.02）。在 FAS 中，PPBC 的改善几乎达到了统计学意义（P=0.05），而在 PPS 中则具有统计学意义（P=0.02）。在 FAS 和 PPS 中，两组患者在治疗 4 周时 AUA-SI-QoL 均显著改善（P<0.01 和 P<0.01），而两组之间的尿急评分/排尿、夜间排尿次数/天或 OABSS 无显著差异。此外，未报告与设备相关的严重不良事件。
新型可移动 TTNS 设备的非侵入性神经调节技术治疗 OAB 有效且安全。其便利性和易于维护使其成为一种新的潜在家庭治疗方式。未来需要进一步研究来证实其长期疗效。
