Overactive Bladder (OAB)NCT07540273
Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder
A study testing Ambulatory Transcutaneous Tibial Nerve Stimulation and Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation in people with Overactive Bladder (OAB) and Urinary Urgency, run by SEZGIN at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overactive Bladder (OAB), Urinary Urgency
- What is being tested?
- Ambulatory Transcutaneous Tibial Nerve Stimulation and Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Feb 2027
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Clinical diagnosis of overactive bladder (OAB)
- Working in an office setting or spending most of the day at home, suitable for using a portable TENS device
Who cannot join
- Pregnancy
- Cardiac pacemaker
- Epilepsy
- Metal implant in the ankle area
- Open wound or skin disease at the electrode site
- Active urinary tract infection
Show all 10Show fewer
- Neurological disease affecting bladder function
- Previous surgery for urinary incontinence or OAB
- Current anticholinergic or beta-3 agonist use for OAB
- Cognitive impairment preventing proper device use
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
Başakşehir Çam and Sakura City Hospital, Department of Urology
Istanbul, Istanbul, 34200
Veysel Sezgin Sezgin, M.D., 90 5513895655, veyselsezgin1@gmail.com
About this study
Official title: A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:
- Does using TENS at home during daily activities reduce the number of urgency episodes?
- Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?
Read more
Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):
- Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions.
- Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.
Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).
Participants will:
- Complete bladder symptom questionnaires before and after the study
- Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage
- Answer quality of life questions at the start and at 4 weeks
Read the detailed description
Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate. It may also cause frequent urination during the day and night, and sometimes urine leakage. Transcutaneous tibial nerve stimulation (TTNS) is a safe, non-invasive treatment that uses mild electrical impulses through the skin near the ankle to calm bladder activity. The posterior tibial nerve at the ankle shares the same spinal nerve roots (L4-S3) that control the bladder.
Current TTNS protocols require regular clinic visits on a fixed schedule. This study introduces an ambulatory approach where participants use a portable TENS device in their daily life when urgency symptoms occur, rather than attending scheduled clinic sessions.
This is a prospective, single-center, randomized controlled trial conducted at Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey. A total of 30 to 50 adults aged 18 to 65 with a clinical diagnosis of OAB who have not improved enough with lifestyle changes and behavioral therapy will be enrolled.
Participants will be randomly placed into one of two groups:
Group 1 - Conventional TTNS: Clinic-based sessions, twice per week for 2 weeks (4 sessions total), each lasting 30 minutes.
Group 2 - Ambulatory TTNS: Participants will receive a portable TENS device and use it at home during daily activities when they experience urgency, over a 4-week follow-up period.
Both groups will use the same stimulation settings: 20 Hz frequency and 200 µs pulse width. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. The intensity will be set at a comfortable level just below the point that causes muscle movement.
Outcomes will be measured at baseline and at 4 weeks using OAB symptom scores (OAB-V8 and/or OABSS), a 3-day voiding diary (urinary frequency, urgency episodes, incontinence episodes), and quality of life questionnaires. Treatment adherence, patient satisfaction, and any side effects will also be recorded.
- Conditions
- Overactive Bladder (OAB), Urinary Urgency
- Being tested
- Ambulatory Transcutaneous Tibial Nerve Stimulation, Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation
- Keywords
- Transcutaneous Tibial Nerve Stimulation, Overactive Bladder, Ambulatory Neuromodulation, Self-Administered Electrical Stimulation, Urinary Urgency
- 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.
Ambulatory Transcutaneous Tibial Nerve StimulationDevice
Participants will use a portable TENS device at home during daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Participants will receive training on correct electrode placement and device use at the first clinic visit.
Conventional Clinic-Based Transcutaneous Tibial Nerve StimulationDevice
Participants will receive TTNS at the clinic twice per week for 2 weeks (4 sessions total), each lasting 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Sessions will be administered by a trained healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Clinic-Based TTNS | Active comparator | Participants will receive transcutaneous tibial nerve stimulation (TTNS) at the clinic twice per week for 2 weeks (4 sessions total). Each session will last 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. Receives: Device: Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation |
| Ambulatory Self-Administered TTNS | Experimental | Participants will be provided with a portable TENS device and instructed to self-administer TTNS during their daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. Participants will receive training on correct electrode placement and device use at the first visit. Receives: Device: Ambulatory Transcutaneous Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overactive Bladder Symptom Score (OABSS)
OABSS is a 4-item self-administered questionnaire measuring the frequency of daytime urination, nighttime urination, urgency, and urgency urinary incontinence. Total score ranges from 0 to 15. Higher scores indicate more severe OAB symptoms and worse outcome.
Measured: Baseline and 4 weeks
OAB-V8 (Overactive Bladder - V8 Questionnaire)
Description:
OAB-V8 is an 8-item patient-reported questionnaire assessing the bothersomeness of overactive bladder symptoms. Each item is scored from 0 (not at all) to 5 (a very great deal), yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom burden and worse outcome.
Measured: Baseline and 4 weeks
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
The ICIQ-OAB is a patient-reported outcome measure assessing the frequency and bothersomeness of overactive bladder symptoms including daytime urinary frequency, nocturia, urgency, and urgency urinary incontinence. It consists of 4 items, each rated on a symptom frequency scale. Total score ranges from 0 to 16. Higher scores indicate more severe overactive bladder symptoms and worse outcome.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)
Description:
The PGI-I is a single-item patient-reported outcome measure assessing the patient's perception of overall improvement following treatment. The scale ranges from 1 to 7, where 1 = "very much better" and 7 = "very much worse." Lower scores indicate greater patient satisfaction and better outcome. The PGI-I is widely used in urological and overactive bladder clinical trials to assess treatment satisfaction.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start15 Aug 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder (OAB)Studies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEZGIN
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, SEZGIN, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540273
- Sponsor's protocol ID
- KAEK-11/05.11.2025.397
- Status last verified
- Sep 2026
- First submitted
- 12 Apr 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder
- ClinicalTrials.gov ID
- NCT07540273
- Acronym / sponsor ID
- KAEK-11/05.11.2025.397
- Conditions
- Overactive Bladder (OAB), Urinary Urgency
- Keywords
- Transcutaneous Tibial Nerve Stimulation, Overactive Bladder, Ambulatory Neuromodulation, Self-Administered Electrical Stimulation, Urinary Urgency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- SEZGINOther government
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 20 Apr 2026 (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.
The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:
- Does using TENS at home during daily activities reduce the number of urgency episodes?
- Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?
Researchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):
- Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions.
- Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.
Both groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).
Participants will:
- Complete bladder symptom questionnaires before and after the study
- Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage
- Answer quality of life questions at the start and at 4 weeks
Detailed description
Overactive bladder (OAB) is a common condition that causes a sudden, strong need to urinate. It may also cause frequent urination during the day and night, and sometimes urine leakage. Transcutaneous tibial nerve stimulation (TTNS) is a safe, non-invasive treatment that uses mild electrical impulses through the skin near the ankle to calm bladder activity. The posterior tibial nerve at the ankle shares the same spinal nerve roots (L4-S3) that control the bladder.
Current TTNS protocols require regular clinic visits on a fixed schedule. This study introduces an ambulatory approach where participants use a portable TENS device in their daily life when urgency symptoms occur, rather than attending scheduled clinic sessions.
This is a prospective, single-center, randomized controlled trial conducted at Başakşehir Çam and Sakura City Hospital, Istanbul, Turkey. A total of 30 to 50 adults aged 18 to 65 with a clinical diagnosis of OAB who have not improved enough with lifestyle changes and behavioral therapy will be enrolled.
Participants will be randomly placed into one of two groups:
Group 1 - Conventional TTNS: Clinic-based sessions, twice per week for 2 weeks (4 sessions total), each lasting 30 minutes.
Group 2 - Ambulatory TTNS: Participants will receive a portable TENS device and use it at home during daily activities when they experience urgency, over a 4-week follow-up period.
Both groups will use the same stimulation settings: 20 Hz frequency and 200 µs pulse width. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. The intensity will be set at a comfortable level just below the point that causes muscle movement.
Outcomes will be measured at baseline and at 4 weeks using OAB symptom scores (OAB-V8 and/or OABSS), a 3-day voiding diary (urinary frequency, urgency episodes, incontinence episodes), and quality of life questionnaires. Treatment adherence, patient satisfaction, and any side effects will also be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Clinic-Based TTNS | Active comparator | Device: Conventional Clinic-Based Transcutaneous Tibial Nerve StimulationParticipants will receive transcutaneous tibial nerve stimulation (TTNS) at the clinic twice per week for 2 weeks (4 sessions total). Each session will last 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. |
| Ambulatory Self-Administered TTNS | Experimental | Device: Ambulatory Transcutaneous Tibial Nerve StimulationParticipants will be provided with a portable TENS device and instructed to self-administer TTNS during their daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters will be set at 20 Hz frequency and 200 µs pulse width, with intensity adjusted to the highest comfortable level below the motor threshold. Participants will receive training on correct electrode placement and device use at the first visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 65 years
- Clinical diagnosis of overactive bladder (OAB)
- Working in an office setting or spending most of the day at home, suitable for using a portable TENS device
Key exclusion criteria (10 listed)
- Pregnancy
- Cardiac pacemaker
- Epilepsy
- Metal implant in the ankle area
- Open wound or skin disease at the electrode site
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 |
|---|---|---|
| Ambulatory Transcutaneous Tibial Nerve StimulationParticipants will use a portable TENS device at home during daily activities when they experience urgency symptoms over a 2-week period. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Participants will receive training on correct electrode placement and device use at the first clinic visit. | Device | Ambulatory Self-Administered TTNS |
| Conventional Clinic-Based Transcutaneous Tibial Nerve StimulationParticipants will receive TTNS at the clinic twice per week for 2 weeks (4 sessions total), each lasting 30 minutes. Two surface electrodes will be placed over the posterior tibial nerve near the inner ankle. Stimulation parameters: 20 Hz frequency, 200 µs pulse width, intensity at the highest comfortable level below motor threshold. Sessions will be administered by a trained healthcare professional. | Device | Conventional Clinic-Based TTNS |
Primary outcome
Change in Overactive Bladder Symptom Score (OABSS)
Time frame: Baseline and 4 weeks
OABSS is a 4-item self-administered questionnaire measuring the frequency of daytime urination, nighttime urination, urgency, and urgency urinary incontinence. Total score ranges from 0 to 15. Higher scores indicate more severe OAB symptoms and worse outcome.
OAB-V8 (Overactive Bladder - V8 Questionnaire)
Time frame: Baseline and 4 weeks
Description: OAB-V8 is an 8-item patient-reported questionnaire assessing the bothersomeness of overactive bladder symptoms. Each item is scored from 0 (not at all) to 5 (a very great deal), yielding a total score ranging from 0 to 40. Higher scores indicate greater symptom burden and worse outcome.
Health-Related Quality of Life - International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
Time frame: Baseline and 4 weeks
The ICIQ-OAB is a patient-reported outcome measure assessing the frequency and bothersomeness of overactive bladder symptoms including daytime urinary frequency, nocturia, urgency, and urgency urinary incontinence. It consists of 4 items, each rated on a symptom frequency scale. Total score ranges from 0 to 16. Higher scores indicate more severe overactive bladder symptoms and worse outcome.
1 secondary outcome
Patient Satisfaction - Patient Global Impression of Improvement (PGI-I)
Time frame: 4 weeks
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 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Overactive Bladder (OAB)
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory Transcutaneous Tibial Nerve Stimulation and Conventional Clinic-Based Transcutaneous Tibial Nerve Stimulation in people with Overactive Bladder (OAB) and Urinary Urgency, run by SEZGIN 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 3 inclusion and 10 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 18 Sep 2026. 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. 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 Veysel Sezgin Sezgin, M.D (+905513895655, veyselsezgin1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overactive Bladder Symptom Score (OABSS) (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2026.