Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction

NCT02859844 | Terminated

• 1 other identifier: 2016-01016
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neurogenic Bladder Dysfunction

Outcome Measures

Primary Outcomes (4)

• Number of voids

  6 weeks

• Number of leakages

  6 weeks

• Number of used pads

  6 weeks

• Post void residual (mL)

  6 weeks

Study Arms (2)

TTNS ON

EXPERIMENTAL

Transcutaneous tibial nerve stimulation

Device: Transcutaneous Tibial Nerve Stimulation (TTNS)

TTNS OFF

SHAM COMPARATOR

Sham/placebo stimulation

Device: Transcutaneous Tibial Nerve Stimulation (TTNS)

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS) DEVICE

TTNS OFF; TTNS ON

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (2)

EOC-Ospedale regional Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Universitätsklinik Balgrist

Zurich, Switzerland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: August 9, 2016
• Study Start: October 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

CH (2)