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

Condition(s) studied

Investigational drug(s) / intervention(s)

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 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Incontinence Impact Questionnaire scale — 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.
• Overactive bladder validation score 8 — 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.
• Voiding volume — From enrollment to the end of treatment at 6 weeks
  Voiding volume, one of the uroflowmeter parameters, will be performed using the UFM Device.
• Voiding time — From enrollment to the end of treatment at 6 weeks
  Voiding time, one of the uroflowmeter parameters, will be performed using the UFM.
• Maximum flow rate — From enrollment to the end of treatment at 6 weeks
  Maximum flow rate, one of the uroflowmeter parameters, will be performed using the UFM.
• Time to reach maximum flow — 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.
• Average flow rate — From enrollment to the end of treatment at 6 weeks
  Average flow rate, one of the uroflowmeter parameters, will be performed using the UFM.
• Post-voiding residual urine — 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.
• SDNN (msn) — 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.
• RMSSD (msn) — 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.
• pNN50 (%) — 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.
• TP (msn²) — 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.
• LF (msn²), %LF, LFnorm — 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.
• HF (msn²), %HF, HFnorm — 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.
• LF/HF (msn²) — 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.
• Pelvic Floor Muscle-Contraction average (μV) — 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 (%).
• Pelvic floor muscle contraction MVC (%) — From enrollment to the end of treatment at 6 weeks
  From enrollment to the end of treatment at 8 weeks
• Pelvic floor muscle relaxation mean (μV) — 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 (%).
• Pelvic floor muscle relaxation MVC (%) — 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 (%).
• Pelvic floor muscle contraction onset (s) — 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 (%).

Trial sites (1)

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