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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
110
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.
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.
Clinique Saint Augustin
Bordeaux, France
Hospital Chenevier
Créteil, 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
...and 1 more locations
Patient Global Impression of Improvement Score Measure
The score is measured after 3 months treatment
Time frame: 3 months
Patient global Impression of severity score measure
the patient self-assesses the severity of his lower urinary tract disorders
Time frame: december 1, 2014
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