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Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

NCT07081412 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-23

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

Efficacy 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).

DEVICE

Efficacy 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.

Sponsors & Collaborators

  • Health Institutes of Turkey

    collaborator OTHER_GOV

  • Ege University

    lead OTHER

Principal Investigators

  • Gokay Ozceltik, Associate Professor · Ege University, Faculty of Medicine, Department of Obstetrics and Gynaecology

  • Fuat Kızılay, Associate Professor · Ege University, Faculty of Medicine, Department of Urology

  • Sevtap Gunay Ucurum, Associate Professor · Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT07081412 on ClinicalTrials.gov