Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in International Prostate Symptom Score (IPSS)
研究概览
简要总结
The goal of this clinical trial is to compare the effect of pelvic physical therapy with different types of electrical stimulation(ES) for bladder complaints in people with Parkinson's disease.
The main question it aims to answer is:
What is the effect of pelvic physical therapy with ES for bladder complaints in people with Parkinson's disease.
Secondary question:
What is the most effective type of ES on bladder complaints in people with Parkinson's disease.
Participants will be randomized into three groups. Two different kinds of ES and a sham group. Participants will receive eight session of pelvic physical therapy. Pelvic physical therapy consists of e.g. bladder training, pelvic floor muscle exercises and biofeedback.
详细描述
Parkinson's disease (PD) is the second most common degenerative neurological disease in the elderly. PD is predominantly a movement disorder. In addition, PD is associated with non-motor and autonomic symptoms. Over 75% of PD patients, experience lower urinary tract symptoms (LUTS), one of the most common autonomic symptoms. LUTS consists of urgency, frequency and nocturia with or without urinary incontinence (UI). More than 60% of PD patients experience nocturia. LUTS have a negative impact on Quality of Life(QoL), increases the risk of falls are a barrier to exercise and may lead to early admission into care. Therefore, this potentially increases healthcare related costs. First treatment options for LUTS in the general population are conservative therapy and medication. Conservative therapy consists of e.g., behavioral advice, bladder training, pelvic floor muscle exercises provided by a pelvic physical therapist(PPT) and, electrical stimulation(ES). Knowledge of the effectiveness of conservative treatment options for LUTS in PD is limited. Although ES is used effectively in patients with LUTS, it has not yet been studied in PD patients. ES has hardly any side effects, but there is uncertainty about optimal ES parameters.
Objective: to study the effectiveness of pelvic physical therapy and ES in patients with PD suffering from LUTS.
Study design: Randomized Controlled Trial (RCT).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Questionnaires are online, allowing participants to complete the questionnaires at home at a convenient time.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson's disease
- •≥ 18 years of age
- •Self-reported LUTS
- •Stable Parkinson's medication for at least three months
- •Able and willing to independently read and fill in questionnaires in the Dutch language, sufficient understanding of Dutch language
- •Able to independently visit a pelvic physical therapy practice
排除标准
- •Patients with other neurological diseases
- •Surgery in the pelvic region in the last year
- •Cancer or cancer treatment in the pelvic region
- •Pregnancy
- •Current urinary tract infection
- •Pure stress urinary incontinence without urgency, frequency, nocturia
- •Botox, PTNS or pelvic physical therapy in the last year
- •Sacral neuromodulator
- •Pacemaker and Implantable cardioverter defibrillator (ICD)
- •Deep Brain stimulation (DBS)
结局指标
主要结局
Change in International Prostate Symptom Score (IPSS)
时间窗: Change from baseline at 12 weeks
Questionnaire of bladder function and urination, of last month, validated for men and women, 6-point-scale; contains 8 items, 3 about storage of urine, 4 about urination and 1 of quality of life. Total score of 0-35, with a minimal important difference(MID) of 3, validated in the Netherlands (MID 5.2) A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms. The IPSS is the most prevalent patient-administered questionnaire used in urology.
次要结局
- Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF)(Change from baseline at 12 weeks; at 24 weeks; at one year)
- Change International Consultation on Incontinence Questionnaire-Lower Urinary Tract quality of life (ICIQ-LUTSqol)(Change from baseline at 12 weeks; at 24 weeks; at one year)
- Change in International Prostate Symptom Score (IPSS)(Change from baseline at 24 weeks and at one year.)
- Change in 24 hour bladder diary, bladder volume(Change from baseline at 12 weeks)
- Change in 24 hour bladder diary, frequency of micturition(Change from baseline at 12 weeks)
- Change in 24 hour bladder diary, urgency(Change from baseline at 12 weeks)
- Change in 24 hour bladder diary, urinary incontinence(Change from baseline at 12 weeks)
- Change in International Consultation on Incontinence Questionnaire-Overactive Bladder Short form (ICIQ-OAB)(Change from baseline at 12 weeks; at 24 weeks; at one year)
研究者
Dorien Bennink
Principal Investigator, clinical epidemiologist MSc, of the department of urology,
Leiden University Medical Center