Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract Disorders in Parkinson's Syndrome
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Urologic Diseases
Study type: Interventional

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.
    

Intervention name(s): TENS; Control
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): UROSTIM 2 by SchwaMedica
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: urinary disorders; Parkinson's disease