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Completed

NCT Number: NCT02582151

Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

Neurogenic bladder patients may have symptoms of urinary frequency, urgency, urgency incontinence and voiding symptoms due to bladder dysfunction arising from their underlying neurologic condition. Current treatment options are effective for some patients, however many patients are not optimally managed due to modest efficacy or significant side effects. Second line therapies include intravesical onabotulinum toxin, however it is associated with a risk of urinary retention, and patients with neurologic disorders often are unable to perform self catheterize due to physical limitations. Sacral neuromodulation is associated with an undesirably high cost and potential complications in this population. The use of transcutaneous tibial nerve stimulation is an alternative form of neuromodulation, and it may have some potential benefits over percutaneous tibial nerve stimulation. While some preliminary studies have suggested it may be effective, there are no high quality randomized trials. This proposal is a 3 month, randomized, sham-controlled, clinical trial to evaluate the short term clinical efficacy of at home transcutaneous tibial nerve stimulation. Valid and reliable patient reported outcome measures, and objective measures of incontinence have been included as outcomes.

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Key information

Conditions

Urinary Bladder, Neurogenic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years of age, with a clinical condition associated with neurogenic bladder dysfunction (multiple sclerosis, Parkinson's disease, stroke, dementia, cerebral palsy, spinal cord injury)(27).
  • Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.

Exclusion criteria

  • Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy
  • Stress predominant urinary incontinence
  • Newly added bladder medication or dose change with the last 2 months (Tamsulosin, Silodosin, Alfuzosin, Terazosin, Baclofen, Diazepam, amitriptyline, imipramine, DDAVP, tolterodine, oxybutynin, fesoterodine, darifenacin, solifenacin, trospium, mirabegron)
  • Intravesical botulinum toxin use within the last 1 year
  • Implanted pacemaker or defibrillator
  • History of epilepsy
  • Unable or unwilling to commit to study treatment schedule
  • Pregnant, or possible pregnancy planned for the duration of the study period
  • Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)
  • Documented allergy to patch electrodes or their adhesive
  • Metallic implant within the lower limb

Treatment and study plan

EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine

Device

Percutaneous patch electrodes are used to deliver low level electrical currents.

Primary outcomes

  1. Patient Perception of Bladder Condition Questionnaire

    Time frame: 3 months

    Patient perception of bladder condition (PPBC) question. It is scored from 0 (My bladder condition does not cause me any problems at all) to 5 (My bladder condition causes me many severe problems). Higher numbers are worse outcomes.

Secondary outcomes

  1. Neurogenic Bladder Symptom Score (NBSS) Questionnaire

    Time frame: 3 months

    The NBSS is a patient reported symptom score covering three domains: incontinence, storage/voiding, and consequences. It is scored from 0 to 72, and a higher score is worse outcome.

  2. Qualiveen-Short Form Questionnaire

    Time frame: 3 months

    Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.

  3. 3-day Voiding Diary

    Time frame: 3 months

    Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.

  4. 24hr Incontinence Pad Weights

    Time frame: 3 months

  5. Physician Assessment of Patient Benefit (Global Response Scale)

    Time frame: 3 months

    Completed by physicians based on their assessment after discussion with the patient as to the amount of benefit they received. Reported on a scale of 0 (no benefit) to 7 (substantial benefit)

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2015
Registry last updated
Jan 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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