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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TENS
Control
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring urinary disorders, Parkinson's disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

electrical nerve stimulation (TENS)

Control group

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient Global Impression of Improvement Score Measure
The score is measured after 3 months treatment

Secondary Outcome Measures

Patient global Impression of severity score measure
the patient self-assesses the severity of his lower urinary tract disorders

Full Information

First Posted
July 8, 2014
Last Updated
November 9, 2020
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02190851
Brief Title
Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome
Acronym
UROPARKTENS
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 Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
urinary disorders, Parkinson's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrical nerve stimulation (TENS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
UROSTIM 2 by SchwaMedica
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Patient Global Impression of Improvement Score Measure
Description
The score is measured after 3 months treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Patient global Impression of severity score measure
Description
the patient self-assesses the severity of his lower urinary tract disorders
Time Frame
december 1, 2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier GAME, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Saint Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
Hospital Chenevier
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Hospital Poincare
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Huriez Hospital
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University Hospital
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Name
Uiversity hospital
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
University hospital
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hospital Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
Pontchaillou Hospital
City
Rennes
ZIP/Postal Code
35
Country
France
Facility Name
University hospital
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
UHToulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24115110
Citation
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.
Results Reference
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Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome

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