Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction

Neurogenic Bladder Dysfunction Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02859844
• Other study ID #: 2016-01016
• Status: Terminated
• Phase: N/A
• Start date: October 2016
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 randomized 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, the investigators study will be the first adequately sampled and powered, randomized, placebo-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. This trial 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Refractory LUTD due to a neurological disorder:

• Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)

• Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)

• Combination of urgency frequency syndrome and/or urgency incontinence and chronic 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)

• Age >18 years

• Informed consent

Exclusion Criteria:

• Botulinum A toxin injections in the detrusor and/or urethral sphincter in the last 6 months

• Age <18 years

• Pregnancy

• 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)

• No informed consent

Related Conditions & MeSH terms

• Neurogenic Bladder Dysfunction
• Urinary Bladder, Neurogenic

Intervention

Device:
• Transcutaneous Tibial Nerve Stimulation (TTNS)

Locations

Country	Name	City	State
Switzerland	EOC-Ospedale regional Bellinzona e Valli	Bellinzona
Switzerland	Universitätsklinik Balgrist	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of voids		6 weeks
Primary	Number of leakages		6 weeks
Primary	Number of used pads		6 weeks
Primary	Post void residual (mL)		6 weeks