Clinical trial NCT02190851: Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: urinary disorders
Parkinson's disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-07-15
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Global Impression of Improvement Score Measure
timeFrame: 3 months
Secondary outcomes:
measure: Patient global Impression of severity score measure
timeFrame: december 1, 2014
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Clinique Saint Augustin
city: Creteil
country: France
facility: Hospital Chenevier
city: Garches
country: France
facility: Hospital Poincare
city: Lille
country: France
facility: Huriez Hospital
city: Lyon
country: France
facility: University Hospital
city: Marseille
country: France
facility: Uiversity hospital
city: Paris
country: France
facility: University hospital
city: Pontoise
country: France
facility: Hospital Dubos
city: Rennes
country: France
facility: Pontchaillou Hospital
city: Rouen
country: France
facility: University hospital
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Xavier GAME, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.