Parkinson's DiseaseUROPARKTENSNCT02190851
Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome
A study testing TENS in people with Parkinson's Disease, run by University Hospital, Toulouse at 11 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 11 sitesFrance
- Study dates
- Apr 2015to 21 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Clinique Saint Augustin
Bordeaux, 33074
Hospital Chenevier
Créteil, 94000
Hospital Poincare
Garches, 92380
Huriez Hospital
Lille, 59037
University Hospital
Lyon, 69310
Uiversity hospital
Marseille, 13385
University hospital
Paris, 75013
Hospital Dubos
Pontoise, 95300
Pontchaillou Hospital
Rennes, 35
University hospital
Rouen, 76038
UHToulouse
Toulouse, 31059
About this study
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
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- TENS, Control
- Keywords
- urinary disorders, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called UROSTIM 2 by SchwaMedica
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Global Impression of Improvement Score Measure
The score is measured after 3 months treatment
Measured: 3 months
Secondary outcomes (1)
Patient global Impression of severity score measure
the patient self-assesses the severity of his lower urinary tract disorders
Measured: december 1, 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startApr 2015
- Primary completion31 Oct 2018
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier GAME, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190851
- Sponsor's protocol ID
- 13 7047 01
- Other IDs
- 13-0147
- Acronym
- UROPARKTENS
- Status last verified
- Nov 2020
- First submitted
- 8 Jul 2014
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 24115110Castel-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.
PubMed 40192925
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02190851
- Acronym / sponsor ID
- UROPARKTENS / 13 7047 01
- Conditions
- Parkinson's Disease
- Keywords
- urinary disorders, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electrical nerve stimulation (TENS) | Experimental | Device: TENSTwo 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. |
| Control group | Placebo comparator | Device: ControlThe 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSAlso: UROSTIM 2 by SchwaMedicaTwo 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. | Device | electrical nerve stimulation (TENS) |
| ControlThe 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 group |
Primary outcome
Patient Global Impression of Improvement Score Measure
Time frame: 3 months
The score is measured after 3 months treatment
1 secondary outcome
Patient global Impression of severity score measure
Time frame: december 1, 2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Background: PubMed 24115110Castel-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 publication: PubMed 40192925Castel-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier GAME, MD principal investigator
University Hospital, Toulouse
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Parkinson's Disease, run by University Hospital, Toulouse at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Improvement Score Measure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02190851, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.