50
Participants
Start Date
June 24, 2025
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
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)."
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.
RECRUITING
EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology, Izmir
Health Institutes of Turkey
OTHER_GOV
Ege University
OTHER