Parkinson Disease Clinical Trial
— PD-UDOfficial title:
Randomized Controlled Study to Evaluate the Efficacy of a Cognitive Training Approach to Improve Urinary Dysfunction in Parkinson`s Disease
NCT number | NCT03917732 |
Other study ID # | D418/19 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2019 |
Est. completion date | December 2020 |
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.
Status | Recruiting |
Enrollment | 45 |
Est. completion date | December 2020 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - consenting capacity (MOCA >17) and written consent - idiopathic parkinson syndrome according to UK Brain Bank criteria - female gender Exclusion Criteria: - missing consenting capacity (MOCA <18) - current depressive episode (BDI > 18) - current intake of medication for the treatment of bladder dysfunction |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Neurology, University Hospital Schleswig-Holstein | Kiel | Schleswig-Holstein |
Lead Sponsor | Collaborator |
---|---|
University of Schleswig-Holstein | University of Kiel |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in functional magnet resonance imaging (fMRI) within a Go/NoGo paradigm | The investigators aim to answer the question whether there are different activity patterns in Parkinson's patients with bladder dysfunction compared to Parkinson's patients without bladder dysfunction in the areas involved in bladder function regulation while concerning a Go/NoGo paradigm. | 4 weeks before beginning and 4 weeks after completion of the training | |
Primary | Change in the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) | 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. | 4 weeks before beginning and 4 weeks after completion of the training | |
Primary | Change in the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol) | 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. | 4 weeks before beginning and 4 weeks after completion of the training | |
Primary | Change in the Patient Perception of Bladder Condition (PPBC) | The PPBC is a single-item, global outcome measure for urinary incontinence. | 4 weeks before beginning and 4 weeks after completion of the training | |
Primary | Change in the International Prostate Symptom Score (I-PSS) | 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). | 4 weeks before beginning and 4 weeks after completion of the training | |
Primary | Change in the Uroflowmetric | 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. | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Verbal memory function through the Rey Auditory Verbal Learning Test (RAVLT) | Participants are given a list of 15 unrelated words repeated over five different trials and are asked to repeat. Another list of 15 unrelated words are given and the client must again repeat the original list of 15 words and then again after 30 minutes. | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Visuomotor abilities and nonverbal memory Rey-Osterrieth complex figure test (ROCF) | The Rey-Osterrieth complex figure test (ROCF) is a neuropsychological assessment in which patients are asked to reproduce a complicated line drawing, first by copying it freehand (recognition; measures visuomotor abilities), and then drawing from memory (recall; measures nonverbal memory). | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Verbal short term memory functions through the Digit Span test | Verbal short term memory span measures the number of discrete units over which the patient can successively distribute his attention and still organize them into a working unit. To generalize, it refers to the ability of the patient to reproduce immediately, after one presentation, a series of discrete stimuli in their original order. | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Response inhibition through the Stroop test | The Stroop test is a widely used measure of selective attention that requires interference resolution, response inhibition, and response selection. | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Visual attention and task switching though the Trial Making Test | The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as quickly as possible while still maintaining accuracy. | 4 weeks before beginning and 4 weeks after completion of the training | |
Secondary | Change in the Word fluency through the Regensburger Word Fluency Test | In the Regensburger Word Fluency Test patients have to produce as many words as possible from a given category or beginning with a specific letter within 2 minutes. | 4 weeks before beginning and 4 weeks after completion of the training |
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