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Overactive BladderNCT07463326

The Efficacy of Transcutaneous Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder

A study testing Transcutaneous Tibial Nerve Stimulation in people with Overactive Bladder, run by Inonu University at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study will be conducted on women of reproductive age diagnosed with idiopathic overactive bladder who either do not want to use drug treatment or cannot tolerate it due to side effects. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
Transcutaneous Tibial Nerve Stimulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
23 Mar 2026to 1 Jan 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 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Eligibility criteria include being between 18 and 50 years of age, having an overactive bladder validation score of 8 (AAM-V8) above 7, refusing or being unable to tolerate antimuscarinic or mirabegron treatment, and being able to understand and follow verbal stimuli.

Who cannot join

  • The following criteria were defined as contraindications: pelvic organ prolapse or other anatomical abnormality, being in the postmenopausal period, having used anticholinergic and/or mirabegron treatment within the last 4 weeks, being pregnant or planning to become pregnant during treatment, having an active genitourinary infection, having a mechanical obstruction in the bladder, having a neurological/congenital disorder, having undergone urogynecological surgery within the last 2 months, having concomitant stress incontinence, having previously received transcutaneous tibial nerve stimulation (TTNS) treatment, and having sensory loss in the area where the treatment will be applied.

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
  • Inonu University

    Malatya, Malatya, 44280

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Efficacy of Transcutaneous Tibial Nerve Stimulation in the Treatment of Women Diagnosed With Idiopathic Overactive Bladder

This study will be conducted on women of reproductive age diagnosed with idiopathic overactive bladder who either do not want to use drug treatment or cannot tolerate it due to side effects. Our aim is to examine the effects of a treatment method called transcutaneous tibial nerve stimulation on overactive bladder symptoms, urine flow measurements (uroflowmetry), post-voiding residue, pelvic floor muscle activity, heart rate variability, and quality of life in these individuals.

Being tested
Transcutaneous Tibial Nerve Stimulation, sham Transcutaneous Tibial Nerve Stimulation
Keywords
Tibial Nerve Stimulation, uroflowmeter, heart rate variability, pelvic floor muscles
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.

  • Transcutaneous Tibial Nerve StimulationOther

    The treatment will be conducted twice a week for 30 minutes each time, for a total of 12 sessions over 6 weeks.

  • sham Transcutaneous Tibial Nerve StimulationOther

    Sham Transcutaneous Tibial Nerve Stimulation will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.

Study groups in NCT07463326
Study groupRoleWhat they receive
Intervention groupExperimentalTranscutaneous Tibial Nerve Stimulation will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.
Receives: Other: Transcutaneous Tibial Nerve Stimulation
Control groupSham comparatorSham Transcutaneous Tibial Nerve Stimulation will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.
Receives: Other: sham Transcutaneous Tibial Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incontinence Impact Questionnaire scale

    The scale consists of 7 questions and is rated on a four-point Likert scale. Scores are evaluated out of 100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely bothered by the symptom. An increase in the score on the scale indicates a deterioration in the quality of life.

    Measured: From enrollment to the end of treatment at 6 weeks

  2. Overactive bladder validation score 8

    This allows for a detailed evaluation of the patient in terms of the primary findings of overactive bladder syndrome, such as sudden urge to urinate, daytime urinary frequency, nighttime urinary frequency, and incontinence.

    Measured: From enrollment to the end of treatment at 6 weeks

  3. Voiding volume

    Voiding volume, one of the uroflowmeter parameters, will be performed using the UFM Device.

    Measured: From enrollment to the end of treatment at 6 weeks

  4. Voiding time

    Voiding time, one of the uroflowmeter parameters, will be performed using the UFM.

    Measured: From enrollment to the end of treatment at 6 weeks

  5. Maximum flow rate

    Maximum flow rate, one of the uroflowmeter parameters, will be performed using the UFM.

    Measured: From enrollment to the end of treatment at 6 weeks

  6. Time to reach maximum flow

    Time to reach maximum flow, one of the uroflowmeter parameters, will be performed using the UFM.

    Measured: From enrollment to the end of treatment at 6 weeks

  7. Average flow rate

    Average flow rate, one of the uroflowmeter parameters, will be performed using the UFM.

    Measured: From enrollment to the end of treatment at 6 weeks

  8. Post-voiding residual urine

    The pelvic ultrasound will be performed with a USG device within the first 5 minutes after the UFM test. Pelvic ultrasound is performed with a 5 mHz low-frequency convex USG probe. The convex probe is placed 1-2 cm above the symphysis pubis, and images of the bladder are taken in the transverse and sagittal axes.

    Measured: From enrollment to the end of treatment at 6 weeks

  9. SDNN (msn)

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  10. RMSSD (msn)

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  11. pNN50 (%)

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  12. TP (msn²)

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  13. LF (msn²), %LF, LFnorm

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  14. HF (msn²), %HF, HFnorm

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  15. LF/HF (msn²)

    Electrocardiography (ECG) recording, specifically heart rate variability (HRV), is a method that provides information about sympathovagal balance, calculated based on the variability of intervals between heartbeats. Recordings will be taken in a quiet room, in a supine position. A 3-way bipolar extremity electrode (poly-spectrum-8/ex) with remote Bluetooth connection will be used for ECG recording. The electrodes will be appropriately attached to the wrists and ankles. Participants will be asked to remove any metal objects that may interfere with the ECG (coins, belts, watches, bracelets, phones, etc.). Participants will be instructed beforehand to remain still, silent, breathe normally, and remain in a supine position during the recording.

    Measured: From enrollment to the end of treatment at 6 weeks

  16. Pelvic Floor Muscle-Contraction average (μV)

    It will be evaluated with a surface EMG device. The results of the EMG activity of the muscles will be expressed in microvolts (μV) and percentage (%).

    Measured: From enrollment to the end of treatment at 6 weeks

  17. Pelvic floor muscle contraction MVC (%)

    From enrollment to the end of treatment at 8 weeks

    Measured: From enrollment to the end of treatment at 6 weeks

  18. Pelvic floor muscle relaxation mean (μV)

    It will be evaluated with a surface EMG device. The results of the EMG activity of the muscles will be expressed in microvolts (μV) and percentage (%).

    Measured: From enrollment to the end of treatment at 6 weeks

  19. Pelvic floor muscle relaxation MVC (%)

    It will be evaluated with a surface EMG device. The results of the EMG activity of the muscles will be expressed in microvolts (μV) and percentage (%).

    Measured: From enrollment to the end of treatment at 6 weeks

  20. Pelvic floor muscle contraction onset (s)

    It will be evaluated with a surface EMG device. The results of the EMG activity of the muscles will be expressed in microvolts (μV) and percentage (%).

    Measured: From enrollment to the end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2026
  2. Study start23 Mar 2026
  3. Primary completion10 Nov 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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
Single blind
Who is masked
Investigator
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07463326
Sponsor's protocol ID
2025/7708
Other IDs
TTU-2025-4064
Status last verified
Mar 2026
First submitted
6 Mar 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Tibial Nerve Stimulation in people with Overactive Bladder, run by Inonu 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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 24 Mar 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incontinence Impact Questionnaire scale (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 20 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 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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