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IRCT2013031512820N1 IRCT 2013-04-17 Vice-chancellor for research, Tehran University of Medical Sciences the effect of tibial nerve stimulation on urinary symptoms in multiple sclerosis Effect of percutaneous posterior tibial nerve stimulation on treatment of lower urinary tract symptom in women patient multiple sclerosis who referred to Emam Khomeini hospital 2013-04-04 anticipated 20 Complete https://irct.ir/trial/12825 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Multiple sclerosis. Patients will be treated with 12 sections of electrical posterior tibial stimulation. Each stimulation will be applied for 30 minutes, once a week for 12 weeks, by unilateral insertion of 38 monopolar needle at 60-degree angle, approximately 5cm cephalad to the medial malleolus and slightly posterior to the tibial. Stimulation will be done with .5-9mA current level , 200 microsec pulse and pulse rate of 20 Hz, based on base subjects foot planter motor and sensory response .The age, kind of disease , the average duration of disease, duration of urinary symptom , EDSS, frequency nacturia, PVR and UDS will be recorded. PVR and UDS will be performed after 12 weeks. The effect of stimulation on urodynamic and PVR will be compared of paseline and after stimulation..
public Sarraf Payam
Imam khomeini hospital
Tehran Iran (Islamic Republic of) +98 21 6119 2424 p-sarraf@tums.ac.ir Tehran University of Medical Sciences scientific Sarraf Payam
Imam khomeini hospital
Tehran Iran (Islamic Republic of) +98 21 6119 2424 p-sarraf@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women with Multiple Sclerosis (between 18-55 years old) who have lower urinary symptoms such as urgency, frequency and nacturia with detrusor sphincter dyssynergia or over active bladder refractory to drug therapy (treatment of at least three months with one or two anticholinergic drugs) are included in study. The exclusion criteria are: urinary infection; previous urogenital surgery; renal stone; pregnancy; severe cardiopulmonary diseases; physical inability; diabetes mellitus; other central nervous system diseases. Also, patients who don’t consent do not consider. When the urinary symptoms aggravate, attack of multiple sclerosis appear or weekly treatment are not followed, the patients are also removed from the study. 18 years 55 years Female G35 Multiple sclerosis Treatment - Other Patients will be treated with 12 sections of electrical posterior tibial stimulation. Each stimulation will be applied for 30 minutes, once a week for 12 weeks, by unilateral insertion of 38 monopolar needle at 60-degree angle, approximately 5cm cephalad to the medial malleolus and slightly posterior to the tibial. Stimulation will be done with .5-9mA current level , 200 microsec pulse and pulse rate of 20 Hz, based on base subjects foot planter motor and sensory response .The age, kind of disease , the average duration of disease, duration of urinary symptom , EDSS, frequency nacturia, PVR and UDS will be recorded. PVR and UDS will be performed after 12 weeks. The effect of stimulation on urodynamic and PVR will be compared of paseline and after stimulation. Maximum-systometric-capacity. Timepoint: Before and after intervention. Method of measurement: Urodynamic study. Involuntary detrusor contraction volume. Timepoint: Before and after intervention. Method of measurement: Urodynamic study. Frequency. Timepoint: In each refering. Method of measurement: Ask from the patients. Nacturia. Timepoint: In each refering. Method of measurement: Ask from the patients. PVR. Timepoint: Before and after of stimulation. Method of measurement: Nelaton Catheter. Vice-chancellor for research, Tehran University of Medical Sciences Approved 2013-03-09 Tehran University of Medical Sciences Ethics Committee Tehran University of Medical Sciences Tehran Iran (Islamic Republic of)