Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

Launched by EGE UNIVERSITY · Jul 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Transcutaneous Posterior Tibial Nerve Stimulation (T-PTNS) for women with Overactive Bladder (OAB), a condition that causes a sudden, strong need to urinate. The treatment uses a small device called SmartUric, which patients can use at home to send gentle electrical signals through the skin near the ankle to help control bladder symptoms. The study will use a mobile app to monitor the treatment remotely and securely, comparing real treatment with a sham (or fake) version to see how well it works.

Women aged 18 and older who have been diagnosed with OAB and can use a smartphone app at home may be eligible to join. Participants will need to have stopped certain bladder medications for at least two weeks and be able to use the bathroom independently. If accepted, they will use the device at home while their treatment is tracked through the app and will be followed for one year to see how they respond. The study excludes women who are pregnant, have certain health conditions, or have used similar treatments before. This trial offers a convenient way to try a new bladder treatment without frequent hospital visits, all from the comfort of home.

Gender

FEMALE

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 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