StrokeNCT07740668
Efficacy of Transcutaneous Electrical Stimulation Therapy in the Treatment of Overactive Bladder Developing After Stroke
A study testing posterior tibial nerve stimulation, PTNS in people with Stroke and Overactive Bladder (OAB), run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Stroke, Overactive Bladder (OAB), Tibial Nerve
- What is being tested?
- posterior tibial nerve stimulation, PTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2026to 1 Oct 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 40 to 70 years
- History of ischemic or hemorrhagic stroke at least 6 months before enrollment
- Presence of overactive bladder symptoms
- Ability to provide written informed consent
Who cannot join
- Age outside the study range
- Pregnancy or breastfeeding
- Active urinary tract infection
- Neurogenic conditions other than stroke affecting bladder function
- Inability to comply with study procedures
- Refusal or inability to provide informed consent
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
Kutahya Health Sciences University
Kütahya, Kütahya, 43000
KSBU Evliya Celebi Research Hospital KSBU Evliya Celebi Research Hospital, Hospital Chief, +902743000081, halib_ive@hotmail.com
About this study
This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.
Primary Hypothesis: PTNS therapy will significantly improve OAB symptoms in post-stroke patients compared to standard care/sham stimulation.
Primary Outcome Measure: Change from baseline in Overactive Bladder Symptom Score (OABSS) and/or frequency of urgency episodes as assessed after 12 weeks of treatment."
Read the detailed description
controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.
- Conditions
- Stroke, Overactive Bladder (OAB), Tibial Nerve
- Being tested
- posterior tibial nerve stimulation, PTNS
- Medical subject headings
- Stroke, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
posterior tibial nerve stimulation, PTNSDevice
posterior tibial nerve stimulation, PTNS
| Study group | Role | What they receive |
|---|---|---|
| posterior tibial nerve stimulation, PTNS | Experimental | 50 patient who assessed after 12 weeks of treatment Receives: Device: posterior tibial nerve stimulation, PTNS |
| standart treatment | No intervention | standart treatment group, wil folllow 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in daily frequency of urgency episodes
Number of urgency episodes per 24 hours recorded in patient bladder diary.
Measured: Baseline and at 12 weeks.
Secondary outcomes (1)
Change in micturition frequency
Average number of micturitions per 24 hours.
Measured: Baseline and at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740668
- Sponsor's protocol ID
- AAM-PTNS-2025-01
- Status last verified
- May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results (including demographic data, primary and secondary outcome measures) may be shared with qualified researchers upon reasonable request. Data will be available after publication of the study results for a period of 5 years. Access will be granted following approval of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transcutaneous Electrical Stimulation Therapy in the Treatment of Overactive Bladder Developing After Stroke
- ClinicalTrials.gov ID
- NCT07740668
- Acronym / sponsor ID
- AAM-PTNS-2025-01
- Conditions
- Stroke, Overactive Bladder (OAB), Tibial Nerve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 31 Jul 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.
This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.
Primary Hypothesis: PTNS therapy will significantly improve OAB symptoms in post-stroke patients compared to standard care/sham stimulation.
Primary Outcome Measure: Change from baseline in Overactive Bladder Symptom Score (OABSS) and/or frequency of urgency episodes as assessed after 12 weeks of treatment."
Detailed description
controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| posterior tibial nerve stimulation, PTNS | Experimental | Device: posterior tibial nerve stimulation, PTNS50 patient who assessed after 12 weeks of treatment |
| standart treatment | No intervention | –standart treatment group, wil folllow 12 months |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female
- Age 40 to 70 years
- History of ischemic or hemorrhagic stroke at least 6 months before enrollment
- Presence of overactive bladder symptoms
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Age outside the study range
- Pregnancy or breastfeeding
- Active urinary tract infection
- Neurogenic conditions other than stroke affecting bladder function
- Inability to comply with study procedures
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 |
|---|---|---|
| posterior tibial nerve stimulation, PTNSposterior tibial nerve stimulation, PTNS | Device | posterior tibial nerve stimulation, PTNS |
Primary outcome
Change in daily frequency of urgency episodes
Time frame: Baseline and at 12 weeks.
Number of urgency episodes per 24 hours recorded in patient bladder diary.
1 secondary outcome
Change in micturition frequency
Time frame: Baseline and at 12 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 31 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results (including demographic data, primary and secondary outcome measures) may be shared with qualified researchers upon reasonable request. Data will be available after publication of the study results for a period of 5 years. Access will be granted following approval of a data sharing agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing posterior tibial nerve stimulation, PTNS in people with Stroke and Overactive Bladder (OAB), run by Kutahya Health Sciences 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 31 Jul 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 Halil i ivelik, Assistant Professor, MD (+905423618713, halib_ive@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daily frequency of urgency episodes (time frame: Baseline and at 12 weeks.). 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 31 Jul 2026.