Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT07081412
Status:
RECRUITING
Last Update Posted:
2025-07-23
First Post:
2025-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
Sponsor:
Ege University
Organization:
Study Overview
Official Title:
Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIP-HOME
Brief 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.
Detailed Description:
1. Determination of candidate cases for the study
2. 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)
3. Obtaining the informed consent form (VCF) from the cases who are found suitable and want to participate in the study
4. Creation of follow-up files specific to each patient in digital format and in hard copy for treatment follow-up.
5. 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.
6. 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.
7. Start of 12-week T-PTNS treatment
8. The follow-up of treatment sessions can be monitored remotely by the researchers via the mobile application.
9. 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.
10. 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.
11. 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.
12. According to the 12-week results;
1. Patients whose treatment was completed with the real device and who benefited will be switched to maintenance treatment at the same treatment dose and once a month for 9 months.
2. Patients who did not benefit in the sham treatment group will be given the real device and the same treatment procedure will be applied once a week, 30 minutes/session, for a total of 12 sessions. At the end of the 12 sessions, they will be called to the research center and the same evaluation procedure will be applied to the real device group. Patients who benefited in the sham group will be included in the 6-month maintenance treatment period. In the 3rd month maintenance treatment period, the interim evaluation will be made remotely via the mobile application.
13. 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.
14. 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.
15. 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).
2. 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)
3. Obtaining the informed consent form (VCF) from the cases who are found suitable and want to participate in the study
4. Creation of follow-up files specific to each patient in digital format and in hard copy for treatment follow-up.
5. 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.
6. 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.
7. Start of 12-week T-PTNS treatment
8. The follow-up of treatment sessions can be monitored remotely by the researchers via the mobile application.
9. 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.
10. 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.
11. 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.
12. According to the 12-week results;
1. Patients whose treatment was completed with the real device and who benefited will be switched to maintenance treatment at the same treatment dose and once a month for 9 months.
2. Patients who did not benefit in the sham treatment group will be given the real device and the same treatment procedure will be applied once a week, 30 minutes/session, for a total of 12 sessions. At the end of the 12 sessions, they will be called to the research center and the same evaluation procedure will be applied to the real device group. Patients who benefited in the sham group will be included in the 6-month maintenance treatment period. In the 3rd month maintenance treatment period, the interim evaluation will be made remotely via the mobile application.
13. 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.
14. 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.
15. 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: