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

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: Female

Minimum Age: 18

Healthy Volunteers: f

View:

• Patients who are ≥18 years old and female patients diagnosed with OAB\* in Urology or Urogynecology outpatient clinics and who meet the inclusion criteria

• Being able to continue their T-PTNS\*\* treatment at home with the mobile application and accepting this,

• Having a smartphone compatible with the application for T-PTNS and being able to use the application

• Agreeing to be followed up for one year after treatment,

• Having stopped all antimuscarinics for at least two weeks,

• Being able to stand and use the toilet independently without difficulty,

• Volunteers who are willing to participate, have been informed about the study and have given signed informed consent, stating that they can comply with the requirements and restrictions listed in the informed consent form (ICP) and this protocol.

Locations

Other Locations

Turkey

EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology

RECRUITING

Izmir

Contact Information

Primary

Ahmet Ozgur Yeniel, Professor

drayeniel@hotmail.com

+90 232 343 4 343

Backup

Gokay Ozceltik, Associate Professor

gokayozceltik@hotmail.com

+90 232 343 4 343

Time Frame

Start Date: 2025-06-24

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 50

Treatments

Experimental: Test Device

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

Placebo_comparator: Sham Device

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 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.

Related Therapeutic Areas

Urinary Incontinence

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