Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction
Bladder and TranscUtaneous Tibial Nerve Stimulation for nEurogenic Lower Urinary Tract Dysfunction
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.
Inclusion Criteria:

 -  Informed consent

 -  Age >18 years

 -  Last urethro-cystoscopy and bladder washing cytology within 1 year before inclusion

 -  Last urodynamic investigation within 6 months and no change of bladder medication
 since then

 -  Refractory LUTD due to a neurological disorder:

 1. Neurogenic OAB (i.e. urgency frequency syndrome with or without urgency
 incontinence) refractory to antimuscarinics (pharmacotherapy for at least 4 weeks
 with at least 2 antimuscarinics)

 2. Neurogenic voiding dysfunction (i.e. incomplete bladder emptying/incomplete /
 complete urinary retention) refractory to alpha-blocker (pharmacotherapy with an
 alpha-blocker for at least 4 weeks)

 3. Combination of neurogenic OAB and neurogenic voiding dysfunction (i.e. urgency
 frequency syndrome with or without urgency incontinence and incomplete / complete
 urinary retention) refractory to antimuscarinics (pharmacotherapy for at least 4
 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an
 alpha- blocker for at least 4 weeks)

 -  Motor response by TTNS stimulation at least at one leg

 -  Willing not to change or start any new medications or treatments for the LUT during
 the entire study period (from screening till unblinding)

 Exclusion Criteria:

 -  Contraindications to the investigational product

 -  Known or suspected non-adherence, drug or alcohol abuse

 -  Inability to follow the procedures of the study, e.g. due to language problems,
 psychological disorders, dementia

 -  Participation in another study with investigational drug or product within the 30 days
 preceding and during the present study

 -  Neuromodulation treatment for urological indication in the last six months or ongoing

 -  Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six
 months

 -  Women who are pregnant or breast feeding

 -  Intention to become pregnant during the course of the study

 -  Individuals especially in need of protection (according to Research with Human
 Subjects published by the Swiss Academy of Medical Sciences
 [www.samw.ch/en/News/News.html]

 -  Enrolment of the investigator, his/her family members, employees and other dependent
 persons