RecruitingNot ApplicableNCT07081412

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial

Sponsor

Ege University

Enrollment

50 participants

Start Date

Jun 24, 2025

Study Type

INTERVENTIONAL

Conditions

Overactive Bladder (OAB)Overactive Bladder Syndrome Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Summary

To record the T-PTNS device (SmartUric) treatment performed by the patient at home via a mobile application in a remotely monitorable, secure and interactive manner with registration notes and a sham control group.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week and Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month for people with overactive bladder (oab), overactive bladder syndrome, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEfficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month

T-PTNS treatment will be performed at home with an external generator and two surface electrodes SmartUric medical device. Each T-PTNS session will consist of test and treatment sections. The treatment will be planned and carried out by researchers. The treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond).

DEVICEEfficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week

These are devices that have the same physical appearance, interface and feedback features, but are prepared in a way that they will not provide electrical stimulation during the treatment session. They are delivered to the Contract Research Organization (CRO) by the project manager and are randomized through the CRO and given to the researchers with a code. The duration and frequency of treatment will be the same as the treatment group.