💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month
- Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week
EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology
Izmir, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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