Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

ConditionsOveractive Bladder Syndrome Overactive Bladder (OAB)Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorEge University

About this trial

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

Qualifiers

Patients who are ≥18 years old and female patients diagnosed with OAB* in Urology or Urogynecology outpatient clinics and who meet the inclusion criteria

Being able to continue their T-PTNS** treatment at home with the mobile application and accepting this,

Having a smartphone compatible with the application for T-PTNS and being able to use the application

Agreeing to be followed up for one year after treatment,

Disqualifiers

Patients under the age of 18

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

Patients diagnosed with neurogenic bladder

Patients with Dabetes Mellitus whose blood sugar cannot be controlled

Trial design

Treatments tested in this trial

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

Treatment groups

50 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Ege University

Lead sponsor

Health Institutes of Turkey

Collaborator

Source ClinicalTrials.gov