Lower urinary tract dysfuntion

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 (e.g. hesitancy, weak stream). If left untreated, NLUTD is a risk factor to damage the upper and lower urinary tract. The management of NLUTD is a challenge since conventional conservative therapies often fail and more invasive treatments such as intradetrusor onabotulinumtoxin A injections, bladder augmentation and urinary diversion have to be considered. Neuromodulation therapies including tibial nerve stimulation (TNS) are promising alternative non-invasive treatment options. Randomised controlled trials (RCTs) in patients with non-neurogenic lower urinary tract dysfunction could prove that TNS is an effective and safe treatment. The value in neurological patients, however, is still unclear.

bTUNED (bladder and TranscUtaneous tibial Nerve stimulation for nEurogenic lower urinary tract Dysfunction) fills this gap as the first adequately sampled and powered, randomised, sham-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. 240 patients with refractory NLUTD are included and undergo 12 TTNS sessions within 6 weeks. Neuro-urological and neurophysiological assessments are performed before and after the intervention. The primary outcome of the trial is the success of TTNS. To further evaluate the effect of TTNS, secondary outcomes as the SAGA (a patient reported outcome measure focusing on individual treatment goals), changes in bladder diary parameters, urodynamic parameters, questionnaire scores and neurophysiology parameters are assessed.

bTUNED will provide new insights into the efficacy and safety of TTNS in patients suffering from NLUTD and has the potential to relevantly improve the management of NLUTD in daily clinical practice and to elucidate the underlying mechanisms involved in the neuromodulation process.

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Project Core Team

• Prof. Dr. med. Thomas M. Kessler – Head of project / Sponsor investigator
• Dr. sc. ETH Martina D. Liechti – Study coordinator
  
• Dr. med. Oliver Gross – Study coordinator
• Stephanie A. Stalder – Study coordinator / PhD student

Study Sites

• Department of Neuro-Urology, Balgrist University Hospital, University of Zürich, Zürich, Switzerland
  
• Department of Urology, Cantonal Hospital Aarau, Aarau, Switzerland
• Department of Urology, Lausanne University Hospital, Lausanne, Switzerland
  
• Department of Urology, School of Medicine, University of St. Gallen, St. Gallen, Switzerland
• Department of Neuro-Urology, Azienda Ospedaliera-Universitaria Careggi, Firenze, Italy
• Department of Surgical Sciences, Tor Vergata University and Unit of Urology, Tor Vergata University Hospital, Rome, Italy

Timeline

Start March 2020 – End August 2024

Funding

external pageSwiss Continence Foundationcall_made