NCT02190851

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

November 28, 2025

Status Verified

November 1, 2020

Enrollment Period

3.6 years

First QC Date

July 8, 2014

Last Update Submit

November 21, 2025

Conditions

Parkinson's Disease

Keywords

urinary disordersParkinson's disease

Outcome Measures

Primary Outcomes (1)

  • Patient Global Impression of Improvement Score Measure

    The score is measured after 3 months treatment

    3 months

Secondary Outcomes (1)

  • Patient global Impression of severity score measure

    december 1, 2014

Study Arms (2)

electrical nerve stimulation (TENS)

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

TENSDEVICE

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.

Also known as: UROSTIM 2 by SchwaMedica
electrical nerve stimulation (TENS)
ControlDEVICE

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 group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Clinique Saint Augustin

Bordeaux, 33074, France

Location

Hospital Chenevier

Créteil, 94000, France

Location

Hospital Poincare

Garches, 92380, France

Location

Huriez Hospital

Lille, 59037, France

Location

University Hospital

Lyon, 69310, France

Location

Uiversity hospital

Marseille, 13385, France

Location

University hospital

Paris, 75013, France

Location

Hospital Dubos

Pontoise, 95300, France

Location

Pontchaillou Hospital

Rennes, 35, France

Location

University hospital

Rouen, 76038, France

Location

UHToulouse

Toulouse, 31059, France

Location

Related Publications (2)

  • 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.

    PMID: 24115110BACKGROUND

  • 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.

    PMID: 40192925RESULT

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Xavier GAME, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 15, 2014

Study Start

April 1, 2015

Primary Completion

October 31, 2018

Study Completion

October 21, 2020

Last Updated

November 28, 2025

Record last verified: 2020-11

Locations

FR(11)