Effectiveness of Magnetic Stimulation in Patients With Urinary Incontinence After Radical Prostatectomy: a Prospective Randomized Sham Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incontinence episodes
研究概览
简要总结
MS is a technology developed to non-invasively stimulate the central and peripheral nervous system, is applied in the treatment of UI. The MS technique aims to directly stimulate the pelvic floor muscles and sacral roots in the treatment of UI (3,4).
MS is a more acceptable, relatively painless, non-invasive and suitable electrical treatment method for patients with UI (5).
Data from studies suggest that MS may be beneficial for patients with UI after RP (1,2,5,6,7). In the literature, there are only 3 randomized controlled trials evaluating MS efficacy using a magnetic chair in patients with UI after RP (1,6,8) and one of them was published in Korean (6) and two of them in English(1,8). In these studies, MS was compared with pelvic floor muscle exercises (PFME) or electrical stimulation (ES) (intra-anal).Yokoyama et al.reported that MS and ES treatments had shown to provide earlier continence compared to the control group after RP. MS and ES are recommended as options for patients who want rapid recovery of postoperative UI(1).
Liu et al reported that MS was more effective than PTKE on incontinence symptoms and quality of life (8). However, as far as we know, there is no prospective randomized sham-controlled study evaluating the effectiveness of MS in patients with post-RP UI. In addition, there are no suggestions regarding MS in the guidelines on urinary incontinence management due to insufficient data (9). In this study, sham-controlled efficacy of MS will be evaluated in patients with UI after RP.
Our study is the first prospective randomized controlled trial comparing MS and Sham MS efficacy in patients with UI after RP. In this study, we aimed to evaluate the effectiveness of MS on incontinence related clinical parameters, quality of life, sexual functions, depression and anxiety in patients with UI after RP.
详细描述
This study is a prospective randomized sham-controlled study. The research will be carried out between January 2021 and June 2022 in XXX Physical Medicine and Rehabilitation (PMR) Department Urogynecological Rehabilitation Unit.
After the approval of XXX Faculty of Medicine Ethics Committee, 40 patients who admitted to XXX PMR Polyclinic with RP complaints after UI and who accepted the inclusion criteria directed to the Urogynecological Rehabilitation Unit, will be included in the study.
Patients will be informed about the content, purpose and application of the study and their written consent will be obtained.
Treatment Protocol 40 men with UI after RP who meet the exclusion and inclusion criteria will be divided into 2 groups using a table of random numbers. MS will be applied to the first group and sham MS will be applied to the second group.
Group 1: Magnetic stimulation (Active MS) Group 2: Sham MS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Men with RP with incontinence over ≥50 g / 24 hours
- •Patients within 1 month to 1 year after catheter removal
- •Willingness to complete and do the quality of life scale
- •Understanding procedures, benefits, and possible side effects
- •Being able to give written, informed consent
排除标准
- •History of conservative treatment after RP including MS
- •Previous urological surgery history
- •UI history before RP
- •Transurethral resection of the prostate due to benign prostatic hyperplasia
- •Patients receiving radiotherapy
- •Presence of urinary tract infection
- •Heart failure, presence of a pacemaker, implanted defibrillator
- •Continuing treatment for arrhythmias
- •Undiagnosed lower abdominal pain
- •Electronic device or metallic implant applied to the areas between the lumbar region and lower extremities
- •Use of drugs that may affect bladder function (antimuscarinic, duloxetine, tricyclic antidepressant, etc.)
- •History of neurogenic bladder, peripheral or central neurological pathology
结局指标
主要结局
Incontinence episodes
时间窗: 6 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider improvement
次要结局
- Cure (Dry) and Improvement Rate(6 weeks)
- Level of Anxiety and Depression - Hospital Anxiety and Depression Scale (HAD)(6 weeks)
- Treatment Success (Continence rate)(6 weeks)
- Quality of Life - Incontinence Impact Questionnaire (IIQ-7)(6 weeks)
- Three-day Bladder Diary(6 weeks)
- Level of sexual function - International Index of Erectile Function (IIEF)(6 weeks)
- Treatment satisfaction - Likert scale (1-5 )(6 weeks)
- Severity of incontinence(6 weeks)
研究者
Necmettin Yildiz
PAU
Pamukkale University