NCT07463326

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Mar 2026Jan 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

March 23, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 6, 2026

Last Update Submit

March 23, 2026

Conditions

Overactive Bladder

Keywords

Tibial Nerve Stimulationuroflowmeterheart rate variabilitypelvic floor muscles

Outcome Measures

Primary Outcomes (20)

  • 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.

    From enrollment to the end of treatment at 6 weeks

  • 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.

    From enrollment to the end of treatment at 6 weeks

  • Voiding volume

    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

    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

    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 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

    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

    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)

    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)

    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 (%)

    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)

    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

    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

    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)

    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)

    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 (%)

    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)

    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 (%)

    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)

    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

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

SHAM COMPARATOR

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

Interventions

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.

Intervention group
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.

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 11, 2026

Study Start

March 23, 2026

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)