Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT07081412
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07081412
Study Brief:
Protocol Section:
NCT07081412