Parkinson’s disease with lower urinary tract symptoms Nervous System Diseases
Conditions
Interventions
Current intervention as of 27/03/2019:
The settings of the device will be pre-set and locked by the clinician. The participant will be shown how to apply the two adhesive electrodes to the lower leg a
Sponsors
Glasgow Caledonian University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of Parkinson's disease with self-reported problematic LUT symptoms 2. Capacity to consent/complete self-report outcome measures 3. Ability to apply TTNS (or placebo) independently or has carer who can apply for duration 4. Stable Parkinson’s medication, treatment naïve, treatment failed or continuing treatment with anti-muscarinic medication (group allocation will be minimised to account for these groups).
Exclusion criteria
Exclusion criteria: 1. Pacemaker or implanted electrical device 2. Ulceration or broken skin in area of pad placement 3. History of gynaecological, urological cancer, prostate cancer 4. History of peripheral vascular disease, epilepsy or current urinary tract infection (as per dip stick analysis) 5. Pace-maker, sacral nerve stimulator, receipt of Botox or PTNS within the last year 6. Severe prostatic enlargement as determined by treating clinician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Urinary leakage assessed using ICIQ-UI Short Form questionnaire. The ICIQ-UI SF provides a brief and robust measure to assess the impact of symptoms of urinary incontinence (UI) on quality of life and outcome of treatment. It is validated in both males and females with 4 questions measuring frequency of UI, amount of leakage, overall impact of UI and a self-diagnostic item. Overall Grade A validity, reliability and responsiveness established with rigour on one data set. Scores range from 0-21 overall score with greater values indicating increased severity. 2. Bladder overactivity assessed using International Prostate Symptoms Score (IPSS). The IPSS is based on the answers to seven questions concerning urinary symptoms and has been validated for use in men and women. The questions refer to the following urinary symptoms: 2.1. Incomplete emptying 2.2. Frequency 2.3. Intermittency 2.4. Urgency 2.5. Weak stream 2.6. Straining 2.7. Nocturia 2.8. Patient’s perceived quality of life. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic). Although there are presently no standard recommendations into grading patients with mild, moderate or severe symptoms, patients can be tentatively classified as follows: 0-7 = mildly symptomatic; 8-19 = moderately symptomatic; 20-35 = severely symptomatic. The outcome measures are applied at baseline, at 6 weeks (following intervention period) and at 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Urinary symptom-related quality of life assessed using Qualiveen, an 8-item self-administered questionnaire validated in patients with neurological disorders at baseline, at 6 weeks (following intervention period) and at 12 weeks 2. Parkinson’s disease-specific quality of life assessed using PDQ-8 questionnaire at baseline, at 6 weeks (following intervention period) and at 12 weeks 3. Frequency of micturition, leakage episodes and urgency assessed using a 72-hour bladder diary recorded during the week post-randomisation before commencing the use of the device at home (Week 0), week 7 and week 11. Participants will be advised to start the diary in the morning (first void of that day) following their clinic visit 4. Compliance: Locked compliance within the stimulation unit will record how often and for how long the participant has used the unit during the 6 weeks of intervention and will be downloaded on at clinic on receipt of the unit 5. Concomitant medication assessed using a form completed at the weekly telephone interview and at week 12. All medications that are taken by the patients are considered as concomitant medications in clinical trials and they are critical for proper monitoring of patient safety and well-being 6. Resource use (including visits to the doctor/nurse/hospital, medications bought/prescribed or not prescribed, purchases such as incontinence pads) assessed using a questionnaire completed at 6 and 12 weeks 7. Participation experience and protocol fidelity assessed at 6 weeks using a brief self-completion questionnaire | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSusan;Jaclyn Stratton;McArthur
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Outcome results
None listed