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

Evaluation of Treatment by Transcutaneous Electrical Nerve Stimulation (TENS) of the Posterior Tibial Nerve 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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: TENS; Device: Control

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
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33074
    • Clinique Saint Augustin
  • Créteil, France, 94000
    • Hospital Chenevier
  • Garches, France, 92380
    • Hospital Poincare
  • Lille, France, 59037
    • Huriez Hospital
  • Lyon, France, 69310
    • University Hospital
  • Marseille, France, 13385
    • Uiversity hospital
  • Paris, France, 75013
    • University Hospital
  • Pontoise, France, 95300
    • Hospital Dubos
  • Rennes, France, 35
    • Pontchaillou Hospital
  • Rouen, France, 76038
    • University Hospital
  • Toulouse, France, 31059
    • UHToulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Xavier Game, MD, University Hospital, Toulouse

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 21, 2020

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimated): July 15, 2014

Study Record Updates

• Last Update Posted (Estimated): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Parkinson's disease; urinary disorders
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Therapeutics; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Analgesia; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: 13 7047 01; 13-0147 (Other Grant/Funding Number: French Ministry of Health, PHRC 2013)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED