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IRCT20090301001722N26 IRCT 2023-03-31 Tehran University of Medical Sciences Evaluation the effect of transcranial stimulation in overactive bladder syndrome tDCS A comparative study of the effect of direct current transcranial electrical stimulation and tibial nerve stimulation on the symptoms of women with overactive bladder syndrome 2023-04-20 anticipated 38 Complete https://irct.ir/trial/65600 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: No, Randomization description: The randomization method in this study is simple randomization. A randomization unit is an individual that will be done through a sealed envelope, Blinding description: In this study, patients are blind to treatment because they are unaware of the allocation of study groups. Also, the person evaluating the outcome is blind. N/A Overactive bladder syndrome. Intervention 1: Intervention group: In this group, patients will receive pelvic floor muscle training in addition to direct current trans-cranial stimulation. In the intervention group, all patients will be treated for 12 sessions and each session will last 30 minutes. 20 minutes will be dedicated to brain electrical stimulation and 10 minutes to pelvic floor muscle training. Brain electrical stimulation will be applied to the medial prefrontal cortex area for 4 weeks and 3 sessions every week. Pelvic floor muscle training will be taught for 4 weeks and one session per week. Intervention 2: Control group: In this group, patients will receive pelvic floor muscle training plus transcutaneous stimulation of the tibial nerve. The duration of each session will be 30 minutes, of which 20 minutes will be devoted to stimulating the tibial nerve and 10 minutes to training the pelvic floor muscles. Tibial nerve stimulation will be applied for 4 weeks and 3 sessions every week. Pelvic floor muscle training will be taught for 4 weeks and one session every week. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Zahra Gorji
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran., Enghelab St
Tehran Iran (Islamic Republic of) 1148965111 +98 21 6649 2271 rehabilitation@tums.ac.ir Tehran University of Medical Sciences scientific Zahra Gorji
Faculty of Rehabilitation, corner of Safi Alishah St., Pich Shamiran., Enghelab St
Tehran Iran (Islamic Republic of) 1148965111 77533939 rehabilitation@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women with overactive bladder syndrome between the ages of 18 and 65 Absence of neurological and mental diseases No history of pelvic surgeries Absence of diabetes Absence of cardiac pacemaker Absence of pregnancy Lack of pelvic floor physiotherapy in the last 3 months Absence of lower urinary tract infection Absence of brain tumor No brain surgery No history of epilepsy and convulsions in the last 2 months Absence of metal implants in the skull Not taking drugs that increase the excitability of the brain, such as Ritalin and.. 18 years 65 years Female Pregnancy Urinary tract infection Cancer Presence of metal implants in the skull Heartbeats Unexplained recurrent headaches Rehabilitation Rehabilitation Intervention group: In this group, patients will receive pelvic floor muscle training in addition to direct current trans-cranial stimulation. In the intervention group, all patients will be treated for 12 sessions and each session will last 30 minutes. 20 minutes will be dedicated to brain electrical stimulation and 10 minutes to pelvic floor muscle training. Brain electrical stimulation will be applied to the medial prefrontal cortex area for 4 weeks and 3 sessions every week. Pelvic floor muscle training will be taught for 4 weeks and one session per week. Control group: In this group, patients will receive pelvic floor muscle training plus transcutaneous stimulation of the tibial nerve. The duration of each session will be 30 minutes, of which 20 minutes will be devoted to stimulating the tibial nerve and 10 minutes to training the pelvic floor muscles. Tibial nerve stimulation will be applied for 4 weeks and 3 sessions every week. Pelvic floor muscle training will be taught for 4 weeks and one session every week. Symptoms of frequency, urgency and urinary incontinence. These symptoms all indicate overactive bladder syndrome. Urinary frequency means the number of times a person goes to the toilet to urinate during the day. Urgency means urgency to urinate, and urinary incontinence is the involuntary leakage of urine that usually occurs before a person reaches the bathroom. Timepoint: At the beginning of the study, after 4 weeks in the last session and after a month. Method of measurement: International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module. Pelvic floor muscle strength. Timepoint: At the beginning of the study, after 4 weeks in the last session. Method of measurement: Perineometer instrument. Symptoms of frequency and urinary incontinence. Timepoint: At the beginning of the study, after 4 weeks in the last session and after a month. Method of measurement: International Consultation on Incontinence Questionnaire Overactive Bladder Module. Tehran University of Medical Sciences Approved 2023-03-12 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qods corner., Keshavarz Blvd Tehran Tehran Iran (Islamic Republic of)