A Trial of Transcutaneous Nerve Stimulation for OAB

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's20 enrolled

Overview

Overactive bladder causes urinary frequency, urgency and in some cases urgency incontinence. This study is testing the efficacy of transcutaneous tibial nerve stimulation (using skin patch electrodes via a transcutaneous electrical nerve stimulation (TENS) machine) for the treatment of women with clinical symptoms of overactive bladder.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overactive Bladder

Interventions

Transcutaneous tibial nerve stimulationOTHER

Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.

Sham transcutaneous tibial nerve stimulationOTHER

Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Female, \>18 years of age, with the clinical diagnosis of overactive bladder. 2. Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms. 3. Baseline patient perception of bladder condition score of 2 or higher. Exclusion Criteria: 1. Current or previous percutaneous 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. Abnormal sensory function of the lower limb 12. Metallic implant within the lower limb

Locations (1)

St Josephs Health Care

London, Ontario, Canada

Outcomes

Primary Outcomes

Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)

Patient percention 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.

Time frame: 12 weeks

Secondary Outcomes

Overactive Bladder Questionnaire Short Form (OAB-q SF)

OAB quality of life questionnaire

Time frame: 12 weeks

Voiding Diary

Time frame: 12 weeks

24hr Pad Weights

Time frame: 12 weeks

Physician Assessment of Treatment Benefit

Time frame: 12 weeks

Data from ClinicalTrials.gov

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