Transcutaneous Peripheral Neuromodulation for Neurogenic Bladder

Urinary Bladder, Neurogenic Clinical Trial

Official title:

A Randomized Trial of Transcutaneous Nerve Stimulation for Neurogenic Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582151
• Other study ID #: 107210
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. >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).

2. Failure of behavioral measures and/or pharmacologic therapy to adequately control neurogenic bladder symptoms.

Exclusion Criteria:

1. Current or previous percutaneous/transcutaneous tibial nerve stimulation or sacral neuromodulation therapy

2. Stress predominant urinary incontinence

3. 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)

4. Intravesical botulinum toxin use within the last 1 year

5. Implanted pacemaker or defibrillator

6. History of epilepsy

7. Unable or unwilling to commit to study treatment schedule

8. Pregnant, or possible pregnancy planned for the duration of the study period

9. Active skin disease of the lower legs (dermatitis, cellulitis, eczema, trauma)

10. Documented allergy to patch electrodes or their adhesive

11. Metallic implant within the lower limb

Related Conditions & MeSH terms

• Urinary Bladder, Neurogenic

Intervention

Device:
• EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine
Percutaneous patch electrodes are used to deliver low level electrical currents.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurogenic Bladder Symptom Score (NBSS) Questionnaire	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.	3 months
Secondary	Qualiveen-Short Form Questionnaire	Patient reported questionnaire that measures quality of life among neurogenic bladder patients. Score ranges from 0 to 32. A higher score is worse.	3 months
Secondary	3-day Voiding Diary	Daily urinary frequency as recorded by the patient over 3 days. Summarised as an average daily frequency.	3 months
Secondary	24hr Incontinence Pad Weights		3 months
Secondary	Physician Assessment of Patient Benefit (Global Response Scale)	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)	3 months