Overactive Bladder SyndromeTRIP-HOMENCT07081412
Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
A study testing Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month in people with Overactive Bladder Syndrome and Overactive Bladder (OAB), run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome, Overactive Bladder (OAB), Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
- What is being tested?
- Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology
Izmir, İzmir, 35100
Ahmet Ozgur Yeniel, Professor, +90 232 390 49 08, drayeniel@hotmail.com
Gokay Ozceltik, Associate Professor, +90 232 390 49 08, gokayozceltik@hotmail.com
About this study
Official title: Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled 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.
Read the detailed description
- 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;
- 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.
- 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.
- 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).
- Conditions
- Overactive Bladder Syndrome, Overactive Bladder (OAB), Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
- Being tested
- 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
- Keywords
- overactive bladder, neuromodulation, Posterior Tibial Nerve Stimulation, Quality of Life
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 monthDevice
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).
Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 weekDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month |
| 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. Receives: Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12th week, and 12th month
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline, 12th week, and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start24 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Principal investigator, Gokay Ozceltik, Ege University
- Investigators
- Gokay Ozceltik, Associate Professor, Principal investigator, Ege University, Faculty of Medicine, Department of Obstetrics and GynaecologyFuat Kızılay, Associate Professor, Study chair, Ege University, Faculty of Medicine, Department of UrologySevtap Gunay Ucurum, Associate Professor, Study chair, Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07081412
- Sponsor's protocol ID
- TRIP-HOME
- Acronym
- TRIP-HOME
- Status last verified
- Jul 2025
- First submitted
- 12 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
• Cardozo, L., Rovner, E., Wagg, A., Wein, A., Abrams, P. 2023. Incontinence (7th Edition). Bristol UK: ICI-ICS. International Continence Society.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07081412
- Acronym / sponsor ID
- TRIP-HOME / TRIP-HOME
- Conditions
- Overactive Bladder Syndrome, Overactive Bladder (OAB), Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)
- Keywords
- overactive bladder, neuromodulation, Posterior Tibial Nerve Stimulation, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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;
- 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.
- 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.
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Test Device | Experimental | Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 monthT-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 | Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 weekThese 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
- Having stopped all antimuscarinics for at least two weeks,
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 monthT-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). | Device | Test Device |
| Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 weekThese 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. | Device | Sham Device |
Primary outcome
3-Day Bladder Diary
Time frame: Baseline, 12th week, and 12th month
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.
5 secondary outcomes
Overactive Bladder Questionnaire (OAB-V8)
Time frame: Baseline, 12th week, and 12th month
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline, 12th week, and 12th month
The Overactive Bladder Quality of Life Short-Form (OAB-q SF)
Time frame: Baseline, 12th week, and 12th month
Female Sexual Function Index (FSFI)
Time frame: Baseline, 12th week, and 12th month
Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS Long Form)
Time frame: Baseline, 12th week, and 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Results publication• Cardozo, L., Rovner, E., Wagg, A., Wein, A., Abrams, P. 2023. Incontinence (7th Edition). Bristol UK: ICI-ICS. International Continence Society.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gokay Ozceltik, Associate Professor principal investigator
Ege University, Faculty of Medicine, Department of Obstetrics and Gynaecology
Fuat Kızılay, Associate Professor study chair
Ege University, Faculty of Medicine, Department of Urology
Sevtap Gunay Ucurum, Associate Professor study chair
Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month in people with Overactive Bladder Syndrome and Overactive Bladder (OAB), run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmet Ozgur Yeniel, Professor (+90 232 343 4 343, drayeniel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Day Bladder Diary (time frame: Baseline, 12th week, and 12th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07081412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.