Department of Urology Beaumont Health System, Royal Oak, MI 48073, USA.
Neurourol Urodyn. 2013 Jan;32(1):24-9. doi: 10.1002/nau.22266. Epub 2012 Jun 5.
To evaluate the safety, sustained effectiveness, and treatment interval for percutaneous tibial nerve stimulation (PTNS) for overactive bladder (OAB) therapy through 24 months.
A prospective study following treatment success after 12 weekly PTNS treatments, subjects were prescribed a 14-week tapering protocol, followed by ongoing therapy with a Personal Treatment Plan determined by the investigator and subject to sustain subject OAB symptom improvement. Questionnaires were completed every 3 months, voiding diaries every 6 months; adverse events were reported throughout.
Of 50 subjects enrolled, 35 remained in the study at 24 months. During the 24 months following initial treatment success and a 14-week tapering protocol, mean treatments per month was 1.3. Voiding diary and OAB-q data demonstrate sustained improvement reported at 13 weeks through 24 months. Improvements in frequency, urge incontinence episodes, night-time voids and moderate-to-severe urgency episodes from voiding diaries at 6, 12, 18, and 24 months were statistically significant compared to baseline (prior to initial 12 weekly treatments). Compared to baseline, OAB-q symptom severity scores and health related quality of life scores were statistically significant for improvement at each tested time point. Five mild adverse events of unknown relation to treatment were reported.
Sustained safety and efficacy of PTNS were demonstrated over 24 months with initial success after 12 weekly treatments, followed by a 14-week prescribed tapering protocol and a Personalized Treatment Plan. With an average of 1.3 treatments per month, PTNS therapy is a safe, durable, and valuable long-term OAB treatment option to sustain clinically significant OAB symptom control.
通过 24 个月评估经皮胫神经刺激（PTNS）治疗膀胱过度活动症（OAB）的安全性、持续有效性和治疗间隔。
在 12 周每周一次的 PTNS 治疗后评估治疗成功的前瞻性研究中，受试者被规定了 14 周的逐渐减少方案，然后根据研究者和受试者确定的个人治疗计划继续进行治疗，以维持受试者的 OAB 症状改善。每 3 个月完成一次问卷调查，每 6 个月完成一次排尿日记；报告了整个治疗过程中的不良事件。
在 50 名入组的受试者中，35 名受试者在 24 个月时仍留在研究中。在初始治疗成功和 14 周逐渐减少方案后的 24 个月期间，每月平均治疗次数为 1.3 次。排尿日记和 OAB-q 数据表明，从第 13 周到 24 个月，持续改善得到了报告。与基线（在最初的 12 周治疗之前）相比，6、12、18 和 24 个月时的排尿日记中的频率、急迫性尿失禁发作、夜间排尿次数和中重度急迫性发作的改善具有统计学意义。与基线相比，OAB-q 症状严重程度评分和健康相关生活质量评分在每个测试时间点都有统计学意义的改善。报告了 5 例与治疗无关的轻度不良事件。
在初始 12 周每周治疗成功后，经过 14 周的规定逐渐减少方案和个人化治疗计划，PTNS 在 24 个月内显示出持续的安全性和有效性。每月平均治疗 1.3 次，PTNS 治疗是一种安全、持久和有价值的长期 OAB 治疗选择，可维持临床显著的 OAB 症状控制。
