Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome (UROPARKTENS)
Parkinson's Disease
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring urinary disorders, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Established diagnosis of Parkinson disease or multisystem atrophy
- Refractory lower urinary tract disorders or contra-indications or intolerance to the usual oral treatments
- Patient capable of completing the questionnaires
- Patient whose written informed consent has been obtained
- Patient registered with a social security scheme
Exclusion Criteria:
- Pregnancy and breast-feeding
- Contra-indications to TENS (local skin problems, metal ankle joint replacement, cardiac pacemaker, peripheral neuropathy, subthalamic deep brain stimulation)
- Associated neurological disorders (stroke, dementia, multiple sclerosis, spinal cord lesions, peripheral neuropathy) or urological disorders (bladder outlet obstruction, cancer, pelvic organ prolapse, interstitial cystitis)
- Unilateral neurological disability
- Legally incompetent patient, patient under legal protection
- Participation in another study during the present study
Sites / Locations
- Clinique Saint Augustin
- Hospital Chenevier
- Hospital Poincare
- Huriez Hospital
- University Hospital
- Uiversity hospital
- University hospital
- Hospital Dubos
- Pontchaillou Hospital
- University hospital
- UHToulouse
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
electrical nerve stimulation (TENS)
Control group
Two electrodes are attached around the internal malleolus and connected to the TENS unit, by UROSTIM 2. The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months.
The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.