A Trial of Transcutaneous Nerve Stimulation for OAB

Not Applicable

Completed

• Conditions: Overactive Bladder
• Interventions: Other: Sham transcutaneous tibial nerve stimulation; Other: Transcutaneous tibial nerve stimulation

• Registration Number: NCT02511717
• Lead Sponsor: Lawson Health Research Institute

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-30
• Study Start: 2016-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-01
• Results First Submitted: 2019-09-10
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-01
• Last Update Submitted: 2019-10-01
• Results First Posted: 2019-10-23
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham transcutaneous tibial nerve stimulation	Transcutaneous stimulation in a location and with settings not relation to the bladder nerves, 3x/week for 30 minutes for 12 weeks
Transcutaneous nerve stimulation	Transcutaneous tibial nerve stimulation	Transcutaneous stimulation of the bladder nerves, 3x/week for 30 minutes for 12 weeks

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcome Measure (Patient Percention of Bladder Condition Question)	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 Outcome Measures

Name	Time	Method
Overactive Bladder Questionnaire Short Form (OAB-q SF)	12 weeks	OAB quality of life questionnaire
Voiding Diary	12 weeks
Physician Assessment of Treatment Benefit	12 weeks
24hr Pad Weights	12 weeks

Trial Locations

Locations (1)

St Josephs Health Care; 🇨🇦 London, Ontario, Canada