NCT04315142

Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction

Transcutaneous Tibial Nerve Stimulation (TTNS) for Treating Neurogenic Lower Urinary Tract Dysfunction: A Multicentre, Randomised, Sham-controlled, Double-blind Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neurogenic Bladder Dysfunction

Interventions

Type	Name	Description
DEVICE	Experimental TTNS	30-minute TTNS intervention is performed 2 days a week during a treatment period of 6 weeks
DEVICE	Sham TTNS	30-minute sham intervention is performed 2 days a week during a treatment period of 6 weeks

Timeline

• Start date: 2020-03-01
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2020-03-19
• Last updated: 2025-08-11

Locations

12 sites across 4 countries: Belgium, Brazil, Italy, Switzerland