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| Name | Class |
|---|---|
| Health Institutes of Turkey | OTHER_GOV |
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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.
Determination of candidate cases for the study
Conducting the eligibility assessment for the study according to the protocol (medical history, physical and urogynecological examination, USG, blood, urine analysis and/or culture tests if the researcher deems necessary)
Obtaining the informed consent form (VCF) from the cases who are found suitable and want to participate in the study
Creation of follow-up files specific to each patient in digital format and in hard copy for treatment follow-up.
Initial measurements will be made at the research center. The patient will be asked to fill out a three-day urinary diary, Overactive Bladder Assessment Form (OAB-V8) and International Incontinence Questionnaire-Short Form (ICIQ-UI-SF) for symptom and quality of life assessment. In addition, validated questionnaires such as Female Sexual Function Inventory-(FSFI) and Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) given to the patient in hard copy will be used. These data will be taken as a starting point and recorded in the study follow-up files.
In order to provide and control T-PTNS usage training (The treatment will be applied by the patient at home), the researchers will provide training and sample application support to the patient until it is ensured that the patient can apply the treatment at home.
Start of 12-week T-PTNS treatment
The follow-up of treatment sessions can be monitored remotely by the researchers via the mobile application.
After the treatment session, the patient will be asked to complete the questionnaires included in the treatment follow-up (Three-day bladder diary, OAB-V8 and ICIQ-UI-SF) digitally from home via the mobile application.
The patients will be asked via phone in Weeks 2 or 3 which treatment group they think they are in and their answers will be recorded.
The patients who have completed their 12-session treatment will be invited to the hospital and will be asked to complete the Female Sexual Function Inventory (FSFI), Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) forms given at the study center in addition to the surveys (OAB-V8, ICIQ-UI-SF, Three-day bladder diary) they completed via the mobile application.
According to the 12-week results;
Maintenance treatment will be monitored remotely in 3-month periods and the patients will fill out the digital questionnaires defined on the application every three months. The 3rd and 6th months will be repeated.
All patients who have completed their treatment will be called to the research center after one year of treatment and will be asked to complete the urinary diary and symptomatic questionnaire (OAB-V8 and ICIQ-UI_SF) evaluations as well as the Female Sexual Function Inventory-(FSFI), Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Overactive Bladder Questionnaire-Short Form (OAB-q SF) forms given in hard copy at the study center. At the same time, the researchers may call the patients who benefited after 12 sessions of sham treatment to the research center at the end of one year.
After all the evaluations, statistical analysis will be made at the end of the 12-week treatment and at the end of 1 year. In addition, if the researcher deems it appropriate, statistical analysis can be performed in the interim period (6 weeks, 3 months, 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Device | Experimental | T-PTNS treatment will be performed at home with an external generator and two surface electrode testers. Each T-PTNS session will consist of a test and treatment section. The treatment will be planned and carried out by the researchers. Treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond). |
|
| Sham Device | Placebo Comparator | 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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. | Baseline, 12th week, and 12th month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
born female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmet Ozgur Yeniel, Professor | Contact | +90 232 343 4 343 | drayeniel@hotmail.com | |
| Gokay Ozceltik, Associate Professor | Contact | +90 232 343 4 343 | gokayozceltik@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gokay Ozceltik, Associate Professor | Ege University, Faculty of Medicine, Department of Obstetrics and Gynaecology | Principal Investigator |
| Fuat Kızılay, Associate Professor | Ege University, Faculty of Medicine, Department of Urology |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology | Recruiting | Izmir | İzmir | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | • Cardozo, L., Rovner, E., Wagg, A., Wein, A., Abrams, P. 2023. Incontinence (7th Edition). Bristol UK: ICI-ICS. International Continence Society. |
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Ethical rules in scientific research protect the rights of participants and prevent the sharing of their personal data without their consent. In addition, commercial information may not be shared.
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Randomized Controlled Trial
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|
| Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week | Device | 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. |
|
| Baseline, 12th week, and 12th month |
| 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. | Baseline, 12th week, and 12th month |
| 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. | Baseline, 12th week, and 12th month |
| 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) | Baseline, 12th week, and 12th month |
| Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS Long Form) | The ICIQ-FLUTS Long Form is a comprehensive questionnaire used to assess female lower urinary tract symptoms, including storage, voiding, and incontinence domains. Each item is scored from 0 to 4. It allows for detailed symptom characterization and is frequently utilized in clinical trials to evaluate the severity, bother, and treatment response in women with LUTS. Higher scores indicate greater symptom severity and greater bother. | Baseline, 12th week, and 12th month |
| Sevtap Gunay Ucurum, Associate Professor | Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation | Study Chair |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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