Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial
Ege University
50 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria6
- 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,
- Having stopped all antimuscarinics for at least two weeks,
- Being able to stand and use the toilet independently without difficulty,
- 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 Criteria18
- 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
- Patients with a history of allergic reactions on the skin
- Cases with prolapse greater than Stage-2 according to the POP-Q staging system and extending beyond the hymen
- Cases with a PVR evaluation of 100 ml and above with USG
- Contraindications for T-PTNS treatment (patients with pacemakers, implantable defibrillators or metal prostheses
- Patients with urinary tract infection*
- Having had botox applied to the bladder or pelvic floor muscles within the last year
- Having had a previous surgery related to the pelvic floor
- Current TENS use in the pelvic region, back or legs
- Having received PTNS treatment before
- Use of Interstim or Bion
- Those who do not accept the treatment or follow-up to be performed
- Those who may have problems complying with the requirements of the study plan
- Negative benefit/risk ratio determined by the investigator
- Those who have been included in any other clinical trial or use of investigational drug/device therapy within 30 days before the study visit
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Interventions
T-PTNS treatment will be performed at home with an external generator and two surface electrodes SmartUric medical device. Each T-PTNS session will consist of test and treatment sections. The treatment will be planned and carried out by researchers. The treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond).
These are devices that have the same physical appearance, interface and feedback features, but are prepared in a way that they will not provide electrical stimulation during the treatment session. They are delivered to the Contract Research Organization (CRO) by the project manager and are randomized through the CRO and given to the researchers with a code. The duration and frequency of treatment will be the same as the treatment group.
Locations(1)
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NCT07081412