NCT07081412 Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
| NCT ID | NCT07081412 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ege University |
| Condition | Overactive Bladder Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 ar