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

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ClinicalTrials.gov Identifier: NCT02190851
Recruitment Status : Recruiting
First Posted : July 15, 2014
Last Update Posted : November 27, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: TENS Device: Control Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve for Lower Urinary Tract Disorders in Parkinson's Syndrome
Study Start Date : April 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.

Device: 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.

Other Name: UROSTIM 2 by SchwaMedica
Placebo Comparator: 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.
Device: 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.



Primary Outcome Measures :
  1. Patient Global Impression of Improvement Score Measure [ Time Frame: 3 months ]
    The score is measured after 3 months treatment


Secondary Outcome Measures :
  1. Patient global Impression of severity score measure [ Time Frame: december 1, 2014 ]
    the patient self-assesses the severity of his lower urinary tract disorders



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190851


Contacts
Contact: Xavier GAME, MD 0561323301 game.x@chu-toulouse.fr
Contact: Evelyne CASTEL-LACANAL, MD 0562322801 castel-lacanal.e@chu-toulouse.fr

Locations
France
Clinique Saint Augustin Suspended
Bordeaux, France, 33074
Hospital Chenevier Recruiting
Creteil, France, 94000
Contact: Catherine-Marie LOCHE, MD    0149813253    catherine-marie.loche@ach.aphp.fr   
Hospital Poincare Recruiting
Garches, France, 92380
Contact: Alexia EVEN, MD    0147107072    alexia.even@rpc.aphp.fr   
Huriez Hospital Not yet recruiting
Lille, France, 59037
Contact: BIARDEAU, MD         
University Hospital Recruiting
Lyon, France, 69310
Contact: Alain RUFFION, MD    0472678808    alain.ruffion@chu-lyon.fr   
Uiversity hospital Recruiting
Marseille, France, 13385
Contact: Gilles KARSENTY, MD    0491435502    gilles.karsenty@ap-hm.fr   
University hospital Recruiting
Paris, France, 75013
Contact: Véronique PHE, MD    0142177129    veronique.phe@gmail.com   
Hospital Dubos Recruiting
Pontoise, France, 95300
Contact: Stéphane BART, MD    0130754902    stephane.bart2@orange.fr   
Pontchaillou Hospital Recruiting
Rennes, France, 35
Contact: Benoit PEYRONNET, MD         
University hospital Recruiting
Rouen, France, 76038
Contact: Romain CAREMEL, MD    0232880341    romaincaremel@orange.fr   
University Hospital Withdrawn
Strasbourg, France, 67091
UHToulouse Recruiting
Toulouse, France, 31059
Contact: Xavier GAME, MD    0561323301    game.x@chu-toulouse.fr   
Contact: Evelyne CASTEL-LACANAL, MD    0561322801    castel-lacanal.e@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Xavier GAME, MD University Hospital, Toulouse

Publications:
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02190851     History of Changes
Other Study ID Numbers: 13 7047 01
13-0147 ( Other Grant/Funding Number: French Ministry of Health, PHRC 2013 )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Toulouse:
urinary disorders
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Urologic Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases