Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

NCT02582151 | Completed Results

• 1 other identifier: 107210
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Urinary Bladder, Neurogenic

Outcome Measures

Primary Outcomes (1)

• Patient Perception of Bladder Condition Questionnaire

  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.

  3 months

Secondary Outcomes (5)

• Neurogenic Bladder Symptom Score (NBSS) Questionnaire

  3 months

• Qualiveen-Short Form Questionnaire

  3 months

• 3-day Voiding Diary

  3 months

• 24hr Incontinence Pad Weights

  3 months

• Physician Assessment of Patient Benefit (Global Response Scale)

  3 months

Study Arms (2)

Sham tibial nerve stimulation

SHAM COMPARATOR

Use of peripheral nerve stimulator in a location that will not actively stimulate the tibial nerve.

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

Tibial nerve stimulation

ACTIVE COMPARATOR

Transcutaneous peripheral nerve stimulator in a location that will actively stimulate the tibial nerve.

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

Interventions

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

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

Sham tibial nerve stimulation; Tibial nerve stimulation

Eligibility Criteria

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

You may qualify if:

• \>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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Urinary Bladder, Neurogenic

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Blayne Welk
• Organization: Lawson Health Research

lawson@lawsonresearch.ca

5196466000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 13, 2015
• First Posted: October 21, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 9, 2020
• Results First Posted: January 9, 2020

Record last verified: 2020-01