Division of Urogynecology and Reconstructive Pelvic Surgery, University of Alabama at Birmingham, Bldg. 176F, Suite10382, 619 19th, Street South, Birmingham, AL, 35249, USA.
Int Urogynecol J. 2024 Aug;35(8):1709-1717. doi: 10.1007/s00192-024-05835-y. Epub 2024 Aug 5.
To compare change in urgency urinary incontinence episodes (UUIEs) in women undergoing posterior tibial nerve stimulation (PTNS) plus mirabegron versus PTNS plus placebo for the treatment of refractory urgency urinary incontinence (UUI). The primary hypothesis was that combination therapy is superior to monotherapy.
A randomized controlled trial was performed in individuals identifying as female aged ≥ 18 years with UUI symptoms refractory to second-line treatment or who could not tolerate antimuscarinic medications. Both participants and providers were blinded to medication treatment allocation. Participants were randomized (1:1) to PTNS plus mirabegron or PTNS plus placebo. Participants completed a 3-day bladder diary prior to and after 12-week treatment. Validated symptom distress and impact questionnaires were obtained pre- and post-treatment. The primary outcome was change in mean number of UUIEs on a 3-day bladder diary pre- versus post-treatment between arms. Primary and secondary outcomes were analyzed via sample t tests.
Fifty-four subjects were randomized, mean ± SD baseline age 56.2±15.6 years and body mass index 35.0±9.4 (kg/m); no differences were noted in any clinical-demographic characteristics. There was a significant difference between arms in mean pre- to post-treatment UUIEs, 9.4±3.9, mirabegron versus 5.3±5.5, placebo (p=0.007). Significant differences were found pre- compared with post-treatment in urinary frequency, Overactive Bladder Questionnaire Short Form Symptom Bother and Symptom Health-Related Quality of Life scores.
In subjects undergoing PTNS treatment for refractory UUI and OAB-wet symptoms, the addition of a β-3 agonist produced significant improvement in both objective and subjective overactive bladder symptom outcomes compared with PTNS plus placebo.
比较接受胫骨后神经刺激（PTNS）加米拉贝隆与 PTNS 加安慰剂治疗难治性急迫性尿失禁（UUI）的女性中急迫性尿失禁发作（UUIE）的变化。主要假设是联合治疗优于单药治疗。
对年龄≥18 岁、有 UUI 症状且对二线治疗无效或不能耐受抗毒蕈碱药物的女性个体进行了一项随机对照试验。参与者和提供者均对药物治疗分配不知情。参与者以 1:1 的比例随机分为 PTNS 加米拉贝隆或 PTNS 加安慰剂组。参与者在治疗前和治疗后 12 周完成了为期 3 天的膀胱日记。在治疗前后获得了经过验证的症状困扰和影响问卷。主要结局是治疗前后 3 天膀胱日记中 UUIE 的平均数量变化，手臂之间的差异。通过样本 t 检验分析主要和次要结局。
54 名受试者被随机分配，平均基线年龄±标准差为 56.2±15.6 岁，体重指数 35.0±9.4（kg/m）；任何临床人口统计学特征均无差异。与安慰剂相比，米拉贝隆组的 UUIE 从治疗前到治疗后有显著差异，9.4±3.9 比 5.3±5.5（p=0.007）。在治疗前与治疗后相比，尿频率、膀胱过度活动症问卷短表症状困扰和症状健康相关生活质量评分均有显著差异。
在接受 PTNS 治疗难治性 UUI 和 OAB 湿症状的受试者中，与 PTNS 加安慰剂相比，添加 β-3 激动剂可显著改善客观和主观过度膀胱症状结局。
