Parkinson DiseasePD-UDNCT03917732
Cognitive Therapy for Urinary Dysfunction in Parkinson´s Disease
A study testing cognitive training and pelvic floor training in people with Parkinson Disease and Urinary Disease Other, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Parkinson Disease, Urinary Disease Other
- What is being tested?
- cognitive training and pelvic floor training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- consenting capacity (MOCA >17) and written consent
- idiopathic parkinson syndrome according to UK Brain Bank criteria
- female gender
Who cannot join
- missing consenting capacity (MOCA <18)
- current depressive episode (BDI > 18)
- current intake of medication for the treatment of bladder dysfunction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
Inken Rothkirch, Dr. phil., 0431 500 23985, i.rothkirch@neurologie.uni-kiel.de
Inken Rothkirch, Dr. phil.
About this study
Official title: Randomized Controlled Study to Evaluate the Efficacy of a Cognitive Training Approach to Improve Urinary Dysfunction in Parkinson's Disease
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.
- Conditions
- Parkinson Disease, Urinary Disease Other
- Being tested
- cognitive training, pelvic floor training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive trainingBehavioural
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.
pelvic floor trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| cognitive training | Experimental | 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. Receives: Behavioral: cognitive training |
| pelvic floor training | Active comparator | 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. Receives: Behavioral: pelvic floor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
Change in the Patient Perception of Bladder Condition (PPBC)
The PPBC is a single-item, global outcome measure for urinary incontinence.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
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).
Measured: 4 weeks before beginning and 4 weeks after completion of the training
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
Secondary outcomes (6)
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.
Measured: 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)
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).
Measured: 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
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
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.
Measured: 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
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
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.
Measured: 4 weeks before beginning and 4 weeks after completion of the training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study startApr 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel
- Responsible party
- Principal investigator, Daniela Berg, University Hospital Schleswig-Holstein
- Investigators
- Daniela Berg, Prof. Dr., Study director, Department of Neurology, University Hospital Schleswig- Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917732
- Sponsor's protocol ID
- D418/19
- Acronym
- PD-UD
- Status last verified
- Apr 2019
- First submitted
- 1 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study to Evaluate the Efficacy of a Cognitive Training Approach to Improve Urinary Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03917732
- Acronym / sponsor ID
- PD-UD / D418/19
- Conditions
- Parkinson Disease, Urinary Disease Other
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- University of Kiel
- Study start
- Apr 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cognitive training | Experimental | Behavioral: cognitive trainingThe 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. |
| pelvic floor training | Active comparator | Behavioral: pelvic floor trainingAt 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- consenting capacity (MOCA >17) and written consent
- idiopathic parkinson syndrome according to UK Brain Bank criteria
- female gender
Key exclusion criteria (3 listed)
- missing consenting capacity (MOCA <18)
- current depressive episode (BDI > 18)
- current intake of medication for the treatment of bladder dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive trainingThe 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. | Behavioural | cognitive training |
| pelvic floor trainingAt 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. | Behavioural | pelvic floor training |
Primary outcome
Change in the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB)
Time frame: 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)
Time frame: 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.
Change in the Patient Perception of Bladder Condition (PPBC)
Time frame: 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 International Prostate Symptom Score (I-PSS)
Time frame: 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 Uroflowmetric
Time frame: 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.
6 secondary outcomes
Change in the Verbal memory function through the Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 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)
Time frame: 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
Time frame: 4 weeks before beginning and 4 weeks after completion of the training
Change in the Response inhibition through the Stroop test
Time frame: 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
Time frame: 4 weeks before beginning and 4 weeks after completion of the training
Change in the Word fluency through the Regensburger Word Fluency Test
Time frame: 4 weeks before beginning and 4 weeks after completion of the training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Berg, Prof. Dr. study director
Department of Neurology, University Hospital Schleswig- Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive training and pelvic floor training in people with Parkinson Disease and Urinary Disease Other, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Inken Rothkirch, Dr. phil. (0431 500 23985, i.rothkirch@neurologie.uni-kiel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) (time frame: 4 weeks before beginning and 4 weeks after completion of the training). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2019.