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NCT Number: NCT02190851

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

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).

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Saint Augustin, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TENS

Device

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 names: UROSTIM 2 by SchwaMedica

Control

Device

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 outcomes

  1. Patient Global Impression of Improvement Score Measure

    Time frame: 3 months

    The score is measured after 3 months treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: UROPARKTENS

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jul 15, 2014
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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