NCT01848366

Utilization of the BIOWAVE Device to Treat Overactive Bladder

Biowave Overactive Bladder (OAB) Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Kenneth Peters, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate a response to stimulation of the posterior tibial nerve using the Biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. The investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

Detailed description

Women 18 years old and over with a score of equal to or greater than 4 on the OAB-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. Outcomes measured include Global Response Assessment (GRA) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Biowave Treatment	Twelve weekly treatments

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-05-07
• Last updated: 2016-12-07
• Results posted: 2016-12-07

Locations

1 site across 1 country: United States