Home-based remote posterior tibial nerve stimulation for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with overactive bladder are screened and complete baseline measures including a three-day bladder diary and validated symptom and quality-of-life questionnaires before randomization. Participants are trained to use a transcutaneous posterior tibial nerve stimulation device at home that pairs with a smartphone app and allows remote monitoring. Subjects are randomized to an active device or a placebo (sham) device for a 12-week treatment period, with the active group followed up to 12 months. Treatment sessions and adherence are remotely recorded and clinical outcomes are compared at 12 weeks (and at 12 months for the active arm).

Why it matters

Who can join: the full rules

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

Where it's running

• EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology
  Izmir, İzmir, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Gokay Ozceltik, Associate Professor — Ege University, Faculty of Medicine, Department of Obstetrics and Gynaecology
• Study coordinator: Ahmet Ozgur Yeniel, Professor
• Email: drayeniel@hotmail.com
• Phone: +90 232 343 4 343

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.