Evaluation of transcutaneous electrical tibial nerve stimulation in lower urinary tract dysfunction secondary to a parkinsonian syndrome: Uroparktens-a multicenter randomized placebo-controlled study.

PURPOSE: Lower urinary tract dysfunction (LUTD) is common in parkinsonian syndromes (PS) and requires special treatment due to limitations in the use of certain drugs and the progression of the disease. Tibial nerve stimulation by transcutaneous electrical nerve stimulation (TENS) is a simple, well-tolerated treatment with proven effectiveness in LUTD. The aim of our study was to evaluate the efficacy on urinary symptoms in patients with a parkinsonian syndrome.

METHOD: A prospective, double-blind, multicenter, randomized study to compare the effects of TENS 20 min a day for 3 months with sham stimulation using the 3-month Patient Global Impression of Improvement (PGI-I) score in adults with PS and LUTD for whom conventional treatments had failed. The secondary endpoints studied were 3-month changes in PGI-S (Severity), Urinary Symptom Profile (USP), Qualiveen questionnaire, voiding diary (VD), post-void residue and the rate of complications.

RESULTS: Between 2015 and 2020, 100 patients with a mean age of 68.6 ± 8.4 years were randomized and included in the intention to treat analysis population (ITT). Among them were 71 men and 85 patients with idiopathic Parkinson's disease. Initially, the PGI-S was moderate to severe (score of 3-4) in 80 patients: 38 (83%) in the TENS group and 42 (82%) in the sham group. After 3 months of treatment, 68 patients felt an improvement (PGI-I 1-3): 30 (64%) in the TENS group and 38 (72%) in the sham-stimulation group (p = 0.399). There was no statistically significant difference between the 2 groups regardless of the endpoint considered.

CONCLUSION: The effect of tibial neuromodulation by TENS on urinary disorders in patients with parkinsonian syndrome after 3 months of stimulation was not significantly different from the placebo effect obtained with sham stimulation.