Transcutaneous Electrical Nerve Stimulation (TENS) for Lower Urinary Tract

Status Completed

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).

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02190851
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	N/A
Start date	April 2015
Completion date	October 21, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms