Lim Renly, Liong Men Long, Leong Wing Seng, Khan Nurzalina Abdul Karim, Yuen Kah Hay
School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, Malaysia.
School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, SA, Australia.
Int Urogynecol J. 2018 Jul;29(7):997-1004. doi: 10.1007/s00192-017-3425-1. Epub 2017 Jul 25.
We evaluated patients' perception and satisfaction with nonsurgical pulsed magnetic stimulation (PMS) for treatment of female stress urinary incontinence (SUI) in a randomized, double-blind, sham-controlled trial.
Women with SUI (n = 120) were randomized to either active or sham PMS for 8 weeks (twice/week). Patients answered seven questions on their perception and acceptability, each measured on a 5-point Likert scale. Treatment satisfaction was assessed using two parameters: (i) the single-item question "Overall, please rate how satisfied you are with the treatment" and (ii) Patient Global Impression of Improvement (PGI-I). All adverse events were documented.
A total of 115 patients completed treatments (active: n = 57, sham: n = 58). There were no significant differences between groups in all parameters regarding perception and acceptability (p > 0.05). In terms of treatment satisfaction, a significantly higher proportion of patients in the active group (n = 47/57, 82.4%) were either mostly or completely satisfied compared with those in the sham group (n = 27/58, 46.6%) ((p = 0.001). Similarly, a statistically significantly higher percentage of patients in the active group (n = 39/57, 68.4%) felt much or very much better compared with patients in the sham group (n = 11/58, 19.0%) as measured using the PGI-I (p < 0.001). Three (5.3%) patients in the active group and five (8.6%) in the sham group experienced adverse events (p = 0.72). Regardless of treatment arms, 109 (94.8%) patients would not consider surgical options even if they required further treatment for their condition.
PMS was well accepted, well tolerated, and resulted in a high treatment satisfaction among women with SUI.
在一项随机、双盲、假对照试验中，我们评估了患者对非手术脉冲磁刺激（PMS）治疗女性压力性尿失禁（SUI）的感知和满意度。
将120例SUI女性患者随机分为接受活性PMS或假PMS治疗组，为期8周（每周两次）。患者回答了7个关于其感知和可接受性的问题，每个问题采用5分李克特量表进行测量。使用两个参数评估治疗满意度：（i）单项问题“总体而言，请评价您对治疗的满意程度”；（ii）患者整体改善印象（PGI-I）。记录所有不良事件。
共有115例患者完成治疗（活性组：n = 57，假治疗组：n = 58）。两组在所有感知和可接受性参数方面均无显著差异（p > 0.05）。在治疗满意度方面，活性组中大部分或完全满意的患者比例（n = 47/57，82.4%）显著高于假治疗组（n = 27/他58，46.6%）（p = 0.001）。同样，使用PGI-I测量时，活性组中感觉好多了或非常好多了的患者百分比（n = 39/57，68.4%）在统计学上显著高于假治疗组（n = 11/58，19.0%）（p < 0.001）。活性组中有3例（5.3%）患者和假治疗组中有5例（8.6%）患者发生不良事件（p = 0.72）。无论治疗组如何，109例（94.8%）患者即使病情需要进一步治疗也不会考虑手术选择。
PMS被广泛接受，耐受性良好，并且在SUI女性患者中产生了较高的治疗满意度。
