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Transcutaneous Tibial Nerve Stimulation (TTNS) for Treating Neurogenic Lower Urinary Tract Dysfunction: A Multicentre, Randomised, Sham-controlled, Double-blind Clinical Trial
Many patients with neurological diseases suffer from neurogenic lower urinary tract dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency with or without incontinence and voiding dysfunction. In addition, the upper urinary tract may be jeopardized because of high intravesical pressure caused by detrusor overactivity (DO) with concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment of NLUTD is a challenge since conventional conservative therapies often fail and more invasive treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and urinary diversion have to be considered. Neuromodulation therapies including tibial nerve stimulation (TNS) may be alternative non-invasive treatment options. Indeed, TNS is an effective and safe treatment for idiopathic overactive bladder proven in randomised controlled trials (RCTs), but its value in neurological patients is unclear. In a recent systematic review, the investigators found evidence that TNS might become a promising treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently needed to reach definitive conclusions. However, this study will be the first adequately sampled and powered, randomised, sham-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. It will provide significant insights into the efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is really effective in the neurological population, the investigators findings would completely revolutionize the management of NLUTD in daily clinical practice. Moreover, this interdisciplinary clinical trial will relevantly influence the neurological and urological approach in the management of NLUTD promoting future collaborative projects improving patients' medical care and underlying the pioneering role of Switzerland in the rapidly developing and ambitious research field of neuro-urology.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University Hospital Antwerp
Edegem, Belgium
University of Sao Paulo School of Medicine
São Paulo, Brazil
Careggi University Hospital
Florence, Italy
Tor Vergata University Hospital
Rome, Italy
Inselspital Bern, University Hospital
Bern, Canton of Bern, Switzerland
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, Switzerland
Cantonal Hospital Aarau
Aarau, Switzerland
REHAB Basel
Basel, Switzerland
EOC - Regional Hospital Bellinzona and Valleys
Bellinzona, Switzerland
Centre hospitalier universitaire vaudois CHUV
Lausanne, Switzerland
Start Date
March 1, 2020
Primary Completion Date
July 30, 2025
Completion Date
July 30, 2025
Last Updated
August 11, 2025
48
ACTUAL participants
Experimental TTNS
DEVICE
Sham TTNS
DEVICE
Lead Sponsor
University of Zurich
NCT05312138
NCT01389921
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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