Clinical trial NCT03917732: Cognitive Therapy for Urinary Dysfunction in Parkinson´s Disease
Official title: Randomized Controlled Study to Evaluate the Efficacy of a Cognitive Training Approach to Improve Urinary Dysfunction in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Urinary Disease Other
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: University of Kiel
First posted: 2019-04-17
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module (ICIQ-LUTSqol)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Patient Perception of Bladder Condition (PPBC)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the International Prostate Symptom Score (I-PSS)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Uroflowmetric
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
Secondary outcomes:
measure: Change in the Verbal memory function through the Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Visuomotor abilities and nonverbal memory Rey-Osterrieth complex figure test (ROCF)
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Verbal short term memory functions through the Digit Span test
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Response inhibition through the Stroop test
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Visual attention and task switching though the Trial Making Test
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
measure: Change in the Word fluency through the Regensburger Word Fluency Test
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
Other outcomes:
measure: Changes in functional magnet resonance imaging (fMRI) within a Go/NoGo paradigm
timeFrame: 4 weeks before beginning and 4 weeks after completion of the training
Locations:
city: Kiel
country: Germany
facility: Department of Neurology, University Hospital Schleswig-Holstein
state: Schleswig-Holstein
Study officials:
affiliation: Department of Neurology, University Hospital Schleswig- Holstein
name: Daniela Berg, Prof. Dr.
role: STUDY_DIRECTOR
References: