NCT04999657

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

A Prospective, Multi-center, Randomized Controlled, Double-blind, Superiority Clinical Trial Evaluating the Safety and Efficacy of a Non-invasive Low-frequency Tibial Nerve Stimulator for the Treatment of Overactive Bladder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Medtecx Co Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment of overactive bladder under the premise of ensuring the safety of the subjects and ensuring the scientific nature of the clinical trial. The primary safety endpoint will be device-related adverse events. The primary effectiveness endpoint will be the improvement value of overactive bladder symptom score (OABSS) after 12-week treatment.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DEVICE	Non-invasive low-frequency tibial nerve stimulator (TNS-01)	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: 2021-08-26
• Primary completion: 2022-09-30
• Completion: 2022-12-15
• First posted: 2021-08-11
• Last updated: 2023-01-18

Locations

7 sites across 1 country: China