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Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction

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ClinicalTrials.gov Identifier: NCT02859844
Recruitment Status : Terminated (Termination after a few pilot participants due to further protocol development)
First Posted : August 9, 2016
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Dysfunction Device: Transcutaneous Tibial Nerve Stimulation (TTNS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2016
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Arm Intervention/treatment
Experimental: TTNS ON
Transcutaneous tibial nerve stimulation
Device: Transcutaneous Tibial Nerve Stimulation (TTNS)
Sham Comparator: TTNS OFF
Sham/placebo stimulation
Device: Transcutaneous Tibial Nerve Stimulation (TTNS)



Primary Outcome Measures :
  1. Number of voids [ Time Frame: 6 weeks ]
  2. Number of leakages [ Time Frame: 6 weeks ]
  3. Number of used pads [ Time Frame: 6 weeks ]
  4. Post void residual (mL) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02859844


Locations
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Switzerland
EOC-Ospedale regional Bellinzona e Valli
Bellinzona, Switzerland, 6500
Universitätsklinik Balgrist
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02859844    
Other Study ID Numbers: 2016-01016
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Urinary Bladder, Neurogenic
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases