NCT04758247

Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Theranova, L.L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder (OAB) patients. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be urinary urge incontinence (UUI) responder rate at 12 weeks (a responder is defined as a subject who experiences at least a 50% reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries). Responder rate will be compared between subjects randomized to the active treatment vs. the sham treatment.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	TheraNova Neuromodulation System	The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.

Timeline

• Start date: 2021-10-28
• Primary completion: 2023-12-08
• Completion: 2023-12-08
• First posted: 2021-02-17
• Last updated: 2024-02-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study