Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome
NCT ID: NCT02190851
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2015-04-30
2020-10-21
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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electrical nerve stimulation (TENS)
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.
TENS
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.
Control group
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.
Control
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.
Interventions
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TENS
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.
Control
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Xavier GAME, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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Clinique Saint Augustin
Bordeaux, , France
Hospital Chenevier
Créteil, , France
Hospital Poincare
Garches, , France
Huriez Hospital
Lille, , France
University Hospital
Lyon, , France
Uiversity hospital
Marseille, , France
University hospital
Paris, , France
Hospital Dubos
Pontoise, , France
Pontchaillou Hospital
Rennes, , France
University hospital
Rouen, , France
UHToulouse
Toulouse, , France
Countries
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References
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Castel-Lacanal E, Game X, Clanet M, Gasq D, De Boissezon X, Guillotreau J, Bourg V, Viala F, Rischmann P, Marque P. Urinary complications and risk factors in symptomatic multiple sclerosis patients. Study of a cohort of 328 patients. Neurourol Urodyn. 2015 Jan;34(1):32-6. doi: 10.1002/nau.22495. Epub 2013 Sep 23.
Castel-Lacanal E, Peyronnet B, Karsenty G, Loche CM, Phe V, Chartier-Kastler E, Cornu JN, Biardeau X, Even A, Denys P, Guinet-Lacoste A, Ruffion A, Bart S, Berard E, Game X. Evaluation of transcutaneous electrical tibial nerve stimulation in lower urinary tract dysfunction secondary to a parkinsonian syndrome: Uroparktens-a multicenter randomized placebo-controlled study. World J Urol. 2025 Apr 7;43(1):214. doi: 10.1007/s00345-025-05597-2.
Other Identifiers
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13-0147
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
13 7047 01
Identifier Type: -
Identifier Source: org_study_id
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