Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07081412

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

Sponsor: Ege University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-06-24

Completion Date

2026-12-31

Last Updated

2025-07-23

Healthy Volunteers

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.

Inclusion Criteria: 1. Patients who are ≥18 years old and female patients diagnosed with OAB\* in Urology or Urogynecology outpatient clinics and who meet the inclusion criteria 2. Being able to continue their T-PTNS\*\* treatment at home with the mobile application and accepting this, 3. Having a smartphone compatible with the application for T-PTNS and being able to use the application 4. Agreeing to be followed up for one year after treatment, 5. Having stopped all antimuscarinics for at least two weeks, 6. Being able to stand and use the toilet independently without difficulty, 7. 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. Exclusion Criteria: 1. Patients under the age of 18 2. Patients who are pregnant according to the results of a pregnancy test with urine or blood test, or who are planning a pregnancy during the study period, or who are breastfeeding 3. Patients diagnosed with neurogenic bladder 4. Patients with Dabetes Mellitus whose blood sugar cannot be controlled 5. Patients with a history of allergic reactions on the skin 6. Cases with prolapse greater than Stage-2 according to the POP-Q staging system and extending beyond the hymen 7. Cases with a PVR evaluation of 100 ml and above with USG 8. Contraindications for T-PTNS treatment (patients with pacemakers, implantable defibrillators or metal prostheses 9. Patients with urinary tract infection\* 10. Having had botox applied to the bladder or pelvic floor muscles within the last year 11. Having had a previous surgery related to the pelvic floor 12. Current TENS use in the pelvic region, back or legs 13. Having received PTNS treatment before 14. Use of Interstim or Bion 15. Those who do not accept the treatment or follow-up to be performed 16. Those who may have problems complying with the requirements of the study plan 17. Negative benefit/risk ratio determined by the investigator 18. Those who have been included in any other clinical trial or use of investigational drug/device therapy within 30 days before the study visit

Locations (1)

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

Izmir, İzmir, Turkey (Türkiye)