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

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190851
• Other study ID #: 13 7047 01
• Secondary ID: 13-0147
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: October 21, 2020

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 21, 2020
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Urologic Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Clinique Saint Augustin	Bordeaux
France	Hospital Chenevier	Creteil
France	Hospital Poincare	Garches
France	Huriez Hospital	Lille
France	University Hospital	Lyon
France	Uiversity hospital	Marseille
France	University hospital	Paris
France	Hospital Dubos	Pontoise
France	Pontchaillou Hospital	Rennes
France	University hospital	Rouen
France	UHToulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (1)

Castel-Lacanal E, Gamé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Improvement Score Measure	The score is measured after 3 months treatment	3 months
Secondary	Patient global Impression of severity score measure	the patient self-assesses the severity of his lower urinary tract disorders	december 1, 2014