Underactive Bladder. Other specified disorders of bladder
Conditions
Interventions
Intervention 1: Intervention group: Patients undergo treatment with transcutaneous tibial nerve stimulation. Electrodes are placed near the ankle, along the path of the tibial nerve. Device parameters
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 13 Years
Inclusion criteria
Inclusion criteria: Male and female children between 5 and 13 years old Resistance to standard urotherapy after at least 3 months Urinating less than 4 times a day Post-void residual volume more than 20 ml or more than 10% of the expected bladder capacity Needing to strain to urinate Interrupted or flat, prolonged urine flow pattern Minimal pelvic floor EMG activity during the voiding phase
Exclusion criteria
Exclusion criteria: Presence of neurological diseases Intellectual disability or below-normal intelligence quotient (IQ) Presence of anatomical defects in the urogenital system History of any neuromodulation therapy (PTNS, TTNS, SNS) within the past 12 months Concomitant use of bladder-active medications (anticholinergics, a-blockers, baclofen, or other muscle relaxants) unless discontinued and a minimum 1-month washout period completed prior to baseline assessment Failure to complete the required medication washout period (if applicable) Presence of cardiac pacemakers or metallic implants Presence of skin lesions at the electrode attachment site (near the ankle)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder Voiding Efficiency (BVE): The percentage of urine that is successfully emptied from the bladder in a single void (voided volume relative to voided volume + post-void residual). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry and ultrasonography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Average Urine Flow Rate (Qave): The average speed at which urine can leave the bladder during a voiding event (ml/s). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry.;Maximum Urine Flow Rate (Qmax): The maximum speed at which urine can leave the bladder during a voiding event (ml/s). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry.;Voided Volume (VV): The volume of urine expelled from the bladder during a voiding event (ml). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry.;Voiding Time (VT): The time elapsed from the start of the attempt to void until the end of this process (seconds). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry.;Flow Time (TQ): The duration during which there is measurable urine output by the device (seconds). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Uroflowmetry.;Bladder Capacity: Bladder volume after filling, immediately before permission to void is given (ml). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Ultrasonography.;Post-void Residual (PVR): The amount of urine remaining in the bladder after voiding is complete (ml). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Ultrasonography.;Bladder Wall Thickness (BWT): Total thickness of mucosal, submucosal, and detrusor muscle layers (mm). Timepoint: Beginning of study (baseline), after completion of 4-week treatment, after 4-month follow-up. Method of measurement: Ultrasonography.;Vo | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactArian Hasani
Tehran University of Medical Sciences
Outcome results
None listed