Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07463326

The Efficacy of Transcutaneous Tibial Nerve Stimulation in Women 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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44280, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Transcutaneous tibial nerve stimulation

Other

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 stimulation

Other

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.

Primary outcomes

  1. Incontinence Impact Questionnaire scale

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  2. Overactive bladder validation score 8

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  3. Voiding volume

    Time frame: From enrollment to the end of treatment at 6 weeks

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

  4. Voiding time

    Time frame: From enrollment to the end of treatment at 6 weeks

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

  5. Maximum flow rate

    Time frame: From enrollment to the end of treatment at 6 weeks

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

  6. Time to reach maximum flow

    Time frame: From enrollment to the end of treatment at 6 weeks

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

  7. Average flow rate

    Time frame: From enrollment to the end of treatment at 6 weeks

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

  8. Post-voiding residual urine

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  9. SDNN (msn)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  10. RMSSD (msn)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  11. pNN50 (%)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  12. TP (msn²)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  13. LF (msn²), %LF, LFnorm

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  14. HF (msn²), %HF, HFnorm

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  15. LF/HF (msn²)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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.

  16. Pelvic Floor Muscle-Contraction average (μV)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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 (%).

  17. Pelvic floor muscle contraction MVC (%)

    Time frame: From enrollment to the end of treatment at 6 weeks

    From enrollment to the end of treatment at 8 weeks

  18. Pelvic floor muscle relaxation mean (μV)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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 (%).

  19. Pelvic floor muscle relaxation MVC (%)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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 (%).

  20. Pelvic floor muscle contraction onset (s)

    Time frame: From enrollment to the end of treatment at 6 weeks

    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 (%).

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.