N/A
Completed N=20
A Trial of Transcutaneous Nerve Stimulation for OAB
Source: ClinicalTrials.gov NCT02511717 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question) — 4; 3 units on a scale
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.
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 |
— | — |
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
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. Informational only — not medical advice.