N/A N=20 Randomized Quadruple-blind Treatment

A Trial of Transcutaneous Nerve Stimulation for OAB

Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT02511717 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) — 4; 3 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcutaneous tibial nerve stimulation (Other); Sham transcutaneous tibial nerve stimulation (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)	4; 3	—
SECONDARY Overactive Bladder Questionnaire Short Form (OAB-q SF)	—	—
SECONDARY Voiding Diary	—	—
SECONDARY 24hr Pad Weights	—	—
SECONDARY Physician Assessment of Treatment Benefit	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02511717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.