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.
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,
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
Parallel
Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month
DeviceT-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).
Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week
DeviceThese 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.
3-Day Bladder Diary
The 3-Day Bladder Diary is a structured patient-reported record used to evaluate urinary frequency, volume, fluid intake, urgency episodes, incontinence events, and nocturia across 3 consecutive days. Parameters recorded: * Time of each void * Voided volume (mL) * Fluid intake (time and volume) * Incontinence episodes (yes/no, with type if known) * Urgency (optional, often rated 0-3 or described qualitatively) * Nocturia episodes. At least 30% reduction in 24-hour urinary frequency or defined as at least a 50% reduction in the number of urgency sensations with or without incontinence and/or at least a 30% reduction in 24-hour urinary frequency via a urinary diary filled by the patient for three days.
Overactive Bladder Questionnaire (OAB-V8)
The Overactive Bladder Questionnaire (OAB-V8) is a validated screening tool used to identify the presence and severity of overactive bladder (OAB) symptoms. It includes 8 items that assess the bother associated with urgency, frequency, nocturia, and urge incontinence. Each item is rated on a Likert scale from 0 (not at all) to 5 (a very great deal), with a total score of ≥8 suggesting clinically relevant OAB. The OAB-V8 is commonly used in both clinical practice and research to support diagnosis and monitor symptom burden.
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
The ICIQ-UI Short Form is a validated questionnaire used to assess the severity and impact of urinary incontinence on quality of life. It consists of four items evaluating the frequency, amount, and perceived interference of urinary leakage, as well as a self-diagnostic item for identifying incontinence type. The total score ranges from 0 to 21, with higher scores indicating greater severity.
The Overactive Bladder Quality of Life Short-Form (OAB-q SF)
The OAB-q Short Form is a brief version of the original OAB-q designed to measure symptom bother and the quality of life impact in patients with overactive bladder. It is a patient-reported outcome measure used in clinical studies for efficient and reliable assessment of OAB-related impairments in daily functioning and well-being. The OAB-q Short Form consists of two main subscales: Symptom Bother Subscale (SB): Typically contains 6 items. Health-Related Quality of Life (HRQoL) Subscale: Typically contains 13 items. Each item is scored on a 6-point Likert scale (1-6). Scores are transformed to a 0-100 scale: Higher Symptom Bother scores indicate worse symptoms. Higher HRQoL scores indicate better quality of life. A 10-point change in the transformed score is generally considered clinically meaningful.
Female Sexual Function Index (FSFI)
A 19-item questionnaire evaluating six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. It is widely used in pelvic floor research and helps assess the broader quality-of-life effects of interventions. Scoring Range: 2-36 (higher scores = better function)
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Ege University
Lead sponsor
Health Institutes of Turkey
Collaborator
