Overactive Bladder
Conditions
Keywords
Tibial Nerve Stimulation, uroflowmeter, heart rate variability, pelvic floor muscles
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.
Interventions
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 will be performed for 6 weeks, 2 days a week, for 30 minutes each day, for a total of 12 sessions.
Sponsors
Inonu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%). |
Countries
Turkey (Türkiye)
Outcome results
None listed