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

NCT04999657 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2023-01-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtecx Co Ltd.

    lead INDUSTRY

Principal Investigators

  • Yaoguang Zhang, MD · Beijing Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-26
Primary Completion
2022-09-30
Completion
2022-12-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999657 on ClinicalTrials.gov