NCT02511717

A Trial of Transcutaneous Nerve Stimulation for OAB

A Randomized Trial of Transcutaneous Nerve Stimulation for Overactive Bladder Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
OTHER	Transcutaneous tibial nerve stimulation	Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.
OTHER	Sham transcutaneous tibial nerve stimulation	Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.

Timeline

• Start date: 2016-01-01
• Primary completion: 2019-03-01
• Completion: 2019-04-01
• First posted: 2015-07-30
• Last updated: 2019-10-23
• Results posted: 2019-10-23

Locations

1 site across 1 country: Canada