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

March 23, 2026 updated by: Senem Arda Düz, Inonu University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Malatya
      • Malatya, Malatya, Turkey (Türkiye), 44280
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Other: Transcutaneous Tibial Nerve Stimulation
The treatment will be conducted twice a week for 30 minutes each time, for a total of 12 sessions over 6 weeks.
Sham Comparator: Control group
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.
Other: sham Transcutaneous Tibial Nerve Stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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.
From enrollment to the end of treatment at 6 weeks
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 (%).
From enrollment to the end of treatment at 6 weeks
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
From enrollment to the end of treatment at 6 weeks
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 (%).
From enrollment to the end of treatment at 6 weeks
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 (%).
From enrollment to the end of treatment at 6 weeks
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 (%).
From enrollment to the end of treatment at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/7708
  • TTU-2025-4064 (Other Grant/Funding Number: Inonu University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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