A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female, >18 years of age, with the clinical diagnosis of overactive bladder.
- •Failure of behavioral measures and pharmacologic therapy to adequately control overactive bladder symptoms.
- •Baseline patient perception of bladder condition score of 2 or higher.
Exclusion Criteria
- •Current or previous percutaneous 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
- •Abnormal sensory function of the lower limb
- •Metallic implant within the lower limb
Arms & Interventions
Sham
Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks
Intervention: Sham transcutaneous tibial nerve stimulation (Other)
Transcutaneous nerve stimulation
Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks
Intervention: Transcutaneous tibial nerve stimulation (Other)
Outcomes
Primary Outcomes
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)
Time Frame: 12 weeks
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.
Secondary Outcomes
- Voiding Diary(12 weeks)
- Overactive Bladder Questionnaire Short Form (OAB-q SF)(12 weeks)
- 24hr Pad Weights(12 weeks)
- Physician Assessment of Treatment Benefit(12 weeks)
Investigators
Blayne Welk
Assistant Professor of Surgery
Lawson Health Research Institute