Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome

Study Overview
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Brief Summary
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Only one study has evaluated the effect of TENS in LUTD in Parkinson's syndromes. It was reported at the congress of the Société Interdisciplinaire Francophone d'UroDynamique et de Pelvi-Perinéologie (SIFUD-PP) in 2011 by Ohanessian et al., and comprised 6 female patients with Parkinson's disease (PD) or multisystem atrophy (MSA), with overactive bladder. Transcutaneous electrical nerve stimulation, 20 minutes daily for 6 weeks, was associated with subjective improvement of LUTD assessed with the Patient Global Impression of Improvement (PGI-I) in 5 of the 6 patients. In view of the encouraging results of this pilot study, we hypothesize that TENS treatment may improve LUTD in patients with a Parkinson's syndrome, Parkinson's disease (PD) and multisystem atrophy (MSA).

Detailed Description
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The principal objective is to compare the efficacy of transcutaneous electrical nerve stimulation of the posterior tibial nerve with placebo stimulation, applied 20 minutes daily for 3 months, in Lower Urinary Tract Disorders (LUTD) in patients with Parkinson's disease or multisystem atrophy, evaluated using the PGI-I (Patient Global Impression of improvement) tool. The secondary objectives are to compare the efficacy of TENS with placebo stimulation on change before/after 3 months of treatment on: the intensity of urinary symptoms, evaluated using the Patient Global Impression of Severity (PGI-S) scale the number of voidings in 24 hours, number of episodes of urinary incontinence in 24 hours and maximum bladder capacity, evaluated by a voiding diary over 3 days urinary symptoms, evaluated with the urinary symptom profile (USP) questionnaire quality of life, assessed by the Qualiveen-SF® questionnaire post-void residual volume measured by bladder ultrasound and effect on the development of infectious complications, by comparing the number of urinary infections over 3 months in each group. Lastly, the safety of TENS will be compared with that of placebo stimulation by the occurrence of adverse events during the 3 months of treatment.

Official Title
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Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: TENS
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electrical nerve stimulation (TENS)<br>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. | Device: TENS<br>* Two electrodes are attached around the internal malleolus and connected to the TENS unit. 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.<br>* Other names: UROSTIM 2 by SchwaMedica;|
| Placebo Comparator: Control group<br>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. | Device: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Impression of Improvement Score Measure | The score is measured after 3 months treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global Impression of severity score measure | the patient self-assesses the severity of his lower urinary tract disorders | december 1, 2014 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary disorders, Parkinson's disease