度洛西汀与创新盆底肌训练治疗女性压力性尿失禁的评估（DULOXING）：研究方案临床试验（符合SPIRIT标准）
Evaluation of duloxetine and innovative pelvic floor muscle training in women with stress urinary incontinence (DULOXING): Study protocol clinical trial (SPIRIT Compliant).
作者信息
Hagovska Magdalena, Svihra Jan
机构信息
Department of Physiatry, Balneology, and Medical Rehabilitation, Institution - Faculty of Medicine, PJ Safarik University, Kosice.
Department of Urology, Institution - Jessenius Faculty of Medicine, Martin, Comenius University Bratislava, Slovak Republic.
出版信息
Medicine (Baltimore). 2020 Feb;99(6):e18834. doi: 10.1097/MD.0000000000018834.
INTRODUCTION
There is a lack of published studies about the combination of duloxetine and pelvic floor muscle training (PFMT) in women with stress urinary incontinence (SUI). The aim of our work will be to evaluate the effect of this intervention by assessing whether there is a change in the incontinence episode frequency (IEF), Incontinence Quality of Life (I-QoL), Patient Global Impression of Improvement score (PGI-I) and mean time between voids (MTBV). Combined therapy with duloxetine and PFMT will be compared to duloxetine treatment alone with respect to its efficacy and side effects.
METHODS
This study will be a randomized intervention, parallel, multicenter study in collaboration with 45 urological outpatient clinics at the national level. Patients will be assigned in a 1:1 ratio to the experimental and control groups using simple randomization according to odd and even numbers assigned sequentially to the patients at each clinic. The experimental intervention will be 12 weeks. The experimental group will receive oral treatment with duloxetine at a daily dose of 2 × 40 mg and will be required to perform innovative PFMT. The control group will receive the same oral duloxetine treatment (2 × 40 mg a day) but will not perform PMFT. Data will be collected from both groups before intervention and after the 12-week intervention is completed.
DISCUSSION
The study protocol presents the starting points, design and randomization of an interventional multicenter study to monitor the effect of the combination of duloxetine with innovative PFMT compared to duloxetine treatment alone in women with SUI. This study may provide evidence of the efficacy of this combined treatment for SUI and highlight benefits associated with active approaches to treatment through exercise.
REGISTRATION
This study was retrospectively registered in the ClinicalTrials.go NCT04140253. Protocol version 1.0. date 11.1.2019.
引言
关于度洛西汀与盆底肌训练（PFMT）联合治疗女性压力性尿失禁（SUI）的研究尚无发表。我们这项工作的目的是通过评估失禁发作频率（IEF）、尿失禁生活质量（I-QoL）、患者总体改善印象评分（PGI-I）和平均排尿间隔时间（MTBV）是否发生变化，来评估这种干预措施的效果。将度洛西汀与PFMT联合治疗与单独使用度洛西汀治疗的疗效和副作用进行比较。
方法
本研究将是一项随机干预、平行、多中心研究，与全国45家泌尿外科门诊合作开展。根据各诊所依次分配给患者的奇数和偶数，采用简单随机化的方法将患者按1:1的比例分配到实验组和对照组。实验干预为期12周。实验组将接受每日剂量为2×40mg的度洛西汀口服治疗，并需进行创新性PFMT。对照组将接受相同的度洛西汀口服治疗（每日2×40mg），但不进行PFMT。在干预前和12周干预结束后，从两组收集数据。
讨论
该研究方案介绍了一项干预性多中心研究的起点、设计和随机化情况，以监测与单独使用度洛西汀治疗相比，度洛西汀与创新性PFMT联合治疗对女性SUI的效果。本研究可能为这种联合治疗SUI的疗效提供证据，并突出通过运动采取积极治疗方法的益处。
注册情况
本研究已在ClinicalTrials.gov上进行回顾性注册，注册号为NCT04140253。方案版本1.0，日期为2019年1月11日。
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