Randomized Controlled Study to Evaluate the Efficacy of a Cognitive Training Approach to Improve Urinary Dysfunction in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in the Patient Perception of Bladder Condition (PPBC)
研究概览
简要总结
Idiopathic Parkinson's syndrome (IPS) is one of the most common neurodegenerative diseases. The prevalence and significance of this disease is continuously increasing in the course of demographic change. For many decades, the focus of diagnostics and therapy was on the motor symptoms of IPS. Only in recent years, it has been recognized that Parkinson's patients also suffer from a variety of non-motor symptoms. These have a decisive influence on the patient's quality of life. As one of the most common non-motor symptoms, 55 to 80% of IPS patients suffer from urinary dysfunction. This is associated with a very high impairment of quality of life due to a high degree of stigmatization and impairment of social participation. In clinical everyday life, Parkinson's patients regularly report the occurrence of a strong imperative urge to urinate, which occurs suddenly and is usually triggered by a certain external stimuli. Specific cognitive processing and reflection of these external stimuli seems to help overcome the imperative urge to urinate. From this clinical observation, it can be assumed that the imperative urge to urinate is subject to a certain cognitive control in the sense of targeted inhibition.
The pharmacological therapy of urinary dysfunction in IPS patients is severely restricted and characterized by insufficient proof of efficacy as well as a high potential for side effects. In clinical practice, alpha-blockers and anticholinergics are frequently used, but the evidence base for IPS is inadequate. In addition, there is a highly relevant risk for Parkinson's patients of specific side effects such as orthostatic dysregulation or deterioration of cognition up to psychoses and hallucinations. This greatly limits their use especially in older IPS patients. While the use of dopaminergic medication is essential for the treatment of motor symptoms in Parkinson's patients, a large number of studies have not confirmed sufficient evidence for the efficacy of dopaminergic medication in urinary dysfunction. In addition, non-pharmacological therapy options, in particular pelvic floor training, are used to treat bladder dysfunction. Due to the lack of risk of side effects, pelvic floor training is currently recommended as a first-line therapy option for IPS patients. Initial studies have shown positive effects, but due to the lack of randomized controlled trials, a sufficient evidence base for this has not yet been established.
The aim of the study is to examine whether a purely cognitive therapy approach is suitable to improve subjective and objective symptoms of urinary dysfunction in IPS patients. This therapeutic approach will be compared with the gold standard of pelvic floor training in terms of efficacy.
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
- Single (Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •consenting capacity (MOCA >17) and written consent
- •idiopathic parkinson syndrome according to UK Brain Bank criteria
- •female gender
排除标准
- •missing consenting capacity (MOCA <18)
- •current depressive episode (BDI > 18)
- •current intake of medication for the treatment of bladder dysfunction
研究组 & 干预措施
cognitive training
The cognitive training the investigators are planning consists of three modules which, in their entirety, are intended to help improve bladder dysfunction, which leads to psychological distress in patients: psychoeducation, training of cognitive functions and training in behavioural therapeutic techniques.
The training will take place over six weeks, with two sessions per week in the first three weeks. In the following three weeks the frequency will be reduced to once a week so that there will be 9 sessions. The duration of each training session is 90 minutes.
干预措施: cognitive training (Behavioral)
pelvic floor training
At the beginning of the training, perception of the pelvic floor is the most important factor. The patients should learn the motor skills to consciously perceive and feel the pelvic floor muscles. This requires a lot of concentration and movement control. After this perception phase, the learned movements are internalized. The fine coordination of the pelvic floor muscles is more harmonious and the tensing and relaxing of the muscles becomes easier over time. In the last phase of the training, the movements and muscle activations should be internalised in such a way that they are anchored as automated movement patterns.
The training will take place over six weeks, with two sessions per week in the first three weeks. In the following three weeks the frequency will be reduced to once a week so that there will be 9 sessions. The duration of each training session is 90 minutes.
干预措施: pelvic floor training (Behavioral)
结局指标
主要结局
Change in the Patient Perception of Bladder Condition (PPBC)
时间窗: 4 weeks before beginning and 4 weeks after completion of the training
The PPBC is a single-item, global outcome measure for urinary incontinence.
Change in the Uroflowmetric
时间窗: 4 weeks before beginning and 4 weeks after completion of the training
Uroflowmetry measures the flow of urine. It tracks how fast urine flows, how much flows out, and how long it takes. It's a diagnostic test to assess how well the urinary tract functions.
Change in the International Prostate Symptom Score (I-PSS)
时间窗: 4 weeks before beginning and 4 weeks after completion of the training
The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).
Change in the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
时间窗: 4 weeks before beginning and 4 weeks after completion of the training
The ICIQ-OAB is a questionnaire for evaluating overactive bladder and related impact on quality of life (QoL) and outcome of treatment in men and women in research and clinical practice across the world. The ICIQ-OAB is derived from the fully validated ICSmale and BFLUTS questionnaires and provides a measure to assess the impact of urinary frequency, urgency, urge incontinence and nocturia symptoms.
Change in the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol)
时间窗: 4 weeks before beginning and 4 weeks after completion of the training
The ICIQ-LUTSqol is a psychometrically robust patient-completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients for use in research and clinical practice across the world. The ICIQ-LUTSqol is the King's Health Questionnaire (KHQ) adapted for use within the ICIQ structure and provides a measure to assess the impact of urinary incontinence on quality of life with particular reference to social effects. It is an ideal research tool as it explores in detail the impact on patients' lives of urinary incontinence and can be used as an outcome measure to assess impact of different treatment modalities.
次要结局
- Change in the Verbal memory function through the Rey Auditory Verbal Learning Test (RAVLT)(4 weeks before beginning and 4 weeks after completion of the training)
- Change in the Visuomotor abilities and nonverbal memory Rey-Osterrieth complex figure test (ROCF)(4 weeks before beginning and 4 weeks after completion of the training)
- Change in the Response inhibition through the Stroop test(4 weeks before beginning and 4 weeks after completion of the training)
- Change in the Visual attention and task switching though the Trial Making Test(4 weeks before beginning and 4 weeks after completion of the training)
- Change in the Word fluency through the Regensburger Word Fluency Test(4 weeks before beginning and 4 weeks after completion of the training)
- Change in the Verbal short term memory functions through the Digit Span test(4 weeks before beginning and 4 weeks after completion of the training)
研究者
Daniela Berg
Director of the Department of Neurology
University Hospital Schleswig-Holstein