Bladder Complaints in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Participants may have direct benefits of participating in this study. Participants included in the study will have two additional visits to a research PPT that will last one hour each, at baseline and after treatment. During this visit, a digital pelvic floor muscle (PFM) assessment and an EMG measurement of the PFM will be performed. EMG measurement will be done with a small anal- or vaginal probe. No risks are associated with the use of this probe. Participants will be referred to local PPT's close to the subjects home address for the treatment sessions. Intervention: eight treatment sessions of 30 minutes pelvic physical therapy over a 10-week period. The intervention consists of bladder- and behavioral advice, pelvic floor muscle exercises (PFME), urge suppression techniques, biofeedback and ES with an intra anal or intra vaginal probe. The group is divided into three groups. Group 1: ES with small pulse duration, group 2: ES with broad pulse duration, group 3: (control group) receiving sham ES. No adverse events are expected since pelvic physical therapy and ES in LUTS is usual care in the general population in the Netherlands. Expected burden for the participants is very low.

Official Title
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Lower Urinary Tract Symptoms in Parkinson's Disease Effectiveness of Pelvic Floor Muscle Exercises and Electrical Stimulation, a Randomized Control Trial

Conditions
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Lower Urinary Tract Symptoms, Parkinson Disease

Intervention / Treatment
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* Other: pelvic physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Patients with other neurological diseases Surgery in the pelvic region 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to three parallel arms for the duration of the study.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: electrical stimulation small phase duration<br>phase duration 200 microseconds, frequency 20 Hertz, 20 minutes | Other: pelvic physical therapy<br>* Pelvic floor muscle exercises, biofeedback, bladder training<br>|
| Active Comparator: electrical stimulation broad pulse duration<br>phase duration 1000 microseconds, frequency 8 Hertz, 20 minutes | Other: pelvic physical therapy<br>* Pelvic floor muscle exercises, biofeedback, bladder training<br>|
| Sham Comparator: electrical stimulation inactive 100Hz<br>phase duration 200 microseconds, frequency 100 Hertz, 2 seconds active 20 seconds no output, 20 minutes | Other: pelvic physical therapy<br>* Pelvic floor muscle exercises, biofeedback, bladder training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Prostate Symptom Score (IPSS) | 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. | Change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in International Consultation on Incontinence Questionnaire-Urinary Incontinence Short form (ICIQ-UI SF) | The validated ICIQ-UI SF measures frequency, severity and, impact on QoL in men and women. The ICIQ-UI SF consists of 4 questions on: frequency or urinary incontinence, amount of leakage, overall impact of urinary incontinence, self-diagnostic item. The score ranges between 0-21. A higher score represents worse QoL. | 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) | The validated ICIQ-LUTSqol measures QoL with particular reference to social effects.The ICIQ-LUTSqol consists of 20 questions. Total score ranges between 19-76 with greater values indicating increased impact on QoL. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient. | Change from baseline at 12 weeks; at 24 weeks; at one year | 
| Change in 24 hour bladder diary, bladder volume | 24 hour bladder diary: change in mean of bladder volume. Normal bladder volume ranges between: 250-500ml. | Change from baseline at 12 weeks | 
| Change in 24 hour bladder diary, frequency of micturition | 24 hour bladder diary, change in frequency of micturition. Number of micturition's in 24 hours. Normal frequency with fluid intake of 1.5-2 liters is 6-8 times in 24 hour. | Change from baseline at 12 weeks | 
| Change in 24 hour bladder diary, urgency | 24 hour bladder diary change in urgency scale: patient perception of intensity of urgency scale(PPIUS). 0 No urgency I felt no need to empty my bladder, but did so for other reasons. Mild urgency I could postpone voiding as long as necessary, without fear of wetting myself. Moderate urgency I could postpone voiding for a short while, without fear of wetting myself. Severe urgency I could not postpone voiding, but had to rush to the toilet in order not to wet myself. Urge incontinence I leaked before arriving to the toilet. A higher score on the PPIUS implicates more severe urgency complaints. | Change from baseline at 12 weeks | 
| Change in 24 hour bladder diary, urinary incontinence | 24 hour bladder diary change in urinary incontinence episodes. Number of urinary incontinence episodes in 24 hours. | Change from baseline at 12 weeks | 
| Change in International Prostate Symptom Score (IPSS) | 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. | Change from baseline at 24 weeks and at one year. | 
| Change in International Consultation on Incontinence Questionnaire-Overactive Bladder Short form (ICIQ-OAB) | The validated ICIQ-OAB evaluating overactive bladder and related impact on quality of life (QoL) and outcome of treatment in men and women, measure the impact of urinary frequency, urgency, urge incontinence and nocturia symptoms. It consist of 6 questions. The scores range from 0-16, overall score with greater values indicating increased symptom severity. | Change from baseline at 12 weeks; at 24 weeks; at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson disease, Lower urinary tract symptoms, Electrical simulation, Pelvic floor muscle exercises, Bladder training, Biofeedback