A Trial of Transcutaneous Nerve Stimulation for OAB

Lawson Health Research Institute

Status: Completed

Conditions: Overactive Bladder

Treatments: Other: Transcutaneous tibial nerve stimulation; Other: Sham transcutaneous tibial nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02511717

106903

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Sham

Sham Comparator group

Description:

Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks

Treatment:

Other: Sham transcutaneous tibial nerve stimulation

Transcutaneous nerve stimulation

Active Comparator group

Description:

Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks

Treatment:

Other: Transcutaneous tibial nerve stimulation