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IRCT20210624051692N1 IRCT 2021-09-19 Babol University of Medical Sciences The comparison between Percutaneous posterior tibial nerve stimulation and Biofeedback-assisted pelvic floor muscle training _ The comparison between Percutaneous posterior tibial nerve stimulation and Biofeedback-assisted pelvic floor muscle training on quality of life and episode of voiding in women with overactive bladder 2021-08-22 anticipated 60 Complete https://irct.ir/trial/57073 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After a complete explanation of the treatment methods and obtaining informed consent to participate in the study, patients are randomly divided into two groups by closed envelopes. In this simple randomization method, 60 envelopes are considered. 30 of them are biofeedback and the other 30 are PTNS . Then by merging the cards together and shuffling them, a card is taken out and its allocation is recorded. This merging and shuffling of the cards is then repeated for each patient. N/A Overactive Bladder. Intervention 1: intervention group 1: Receiving electrical stimulation of posterior tibial nerve, 12 sessions (three sessions per week), by portable dual channel TENS devise. Intervention 2: intervention group 2: pelvic floor muscles training with biofeedback, 12 sessions (three sessions per week), by vaginal electrode and MyoTrac Infiniti biofeedback device. 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 -

public Maryam Ebrahimi

Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran

Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴ +98 11 3219 9592 maryamebrahimi.pt89@gmail.com Babol University of Medical Sciences scientific Maryam Ebrahimi

Babol University of Medical Sciences, Ganj Afrooz St., Babol, Mazandaran

Babol Iran (Islamic Republic of) ۴۷۱۷۶-۴۷۷۴۵ +98 11 3219 9592 maryamebrahimi.pt89@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) married women 18 to 45 years with the symptoms of overactive bladder 18 years 45 years Female stress incontinence using pace maker Cognitive impairment diseases Superficial or deep infection at the electrode site Uncontrolled urinary tract infection Neurological diseases and urinary congestion bladder stone Uterine prolapse above second degree according to the POP-Q system Pregnancy or suspected pregnancy or planning for it and cesarean delivery Uncontrolled diabetes mellitus History of surgeries to control incontinence and botulinum toxin injection Pelvic tumors and history of radiotherapy N32.81 N32.81 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. Treatment - Other Treatment - Other intervention group 1: Receiving electrical stimulation of posterior tibial nerve, 12 sessions (three sessions per week), by portable dual channel TENS devise intervention group 2: pelvic floor muscles training with biofeedback, 12 sessions (three sessions per week), by vaginal electrode and MyoTrac Infiniti biofeedback device Number of daily urination. Timepoint: Beginning of the study (before the start of the intervention) - End of the twelfth session - One month after the last session. Method of measurement: Daily Urine Record. Quality of life. Timepoint: Before the intervention - end of the twelfth session - one month after the last session. Method of measurement: Quality of Life Questionnaire in Patients with Incontinence (ICIQ-LUTSqol). Frequent urinary incontinence. Timepoint: Before the intervention - end of the twelfth session - one month after the last session. Method of measurement: Short form of urinary incontinence (ICIQ-UI SF). Number of nocturnal urination. Timepoint: Before the intervention - end of the twelfth session - one month after the last session. Method of measurement: Daily urine record. Number of urinary urgency feeling. Timepoint: Before the intervention - end of the twelfth session - one month after the last session. Method of measurement: Daily urine record. Babol University of Medical Sciences Approved 2021-06-14 Ethics Committee of Babol University of Medical Science Babol University of Medical Sciences, Ganj Afrooz Str., Babol, Mazandaran Babol Mazandaran Iran (Islamic Republic of)