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IRCT20151123025202N41 IRCT 2024-10-03 Hamedan University of Medical Sciences Treatment of post -radical prostatectomy urinary incontinence, comparison of drug treatment and posterior tibial nerve stimulation Comparison of the effects of medical treatment (Duloxetine andSsolifenacine) and Transcutaneous tibia nerve stimulation in the treatment of post- prostatectomy urinary incontinence 2024-10-22 anticipated 60 Complete https://irct.ir/trial/79210 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The envelope method will be used for random allocation. They will be randomly assigned to intervention and control groups. 60 cards are prepared and on 30 cards the letter A means the first group and on the other 30 the letter B means the second group is written and each one is put inside an envelope with aluminum foil and the lid is glued and placed inside a box. At the time of patients' arrival, one of the letter envelopes will be randomly selected and opened. According to the chosen letter (A or B), the patient will be assigned to the nerve stimulation or drug therapy group, Blinding description: Due to the type of interventions, there is no possibility of blinding the patient and the physicians. Only, the person analyzing the data will not know about the treatment groups until the end of the analysis. 2-3 Urinary incontinence. Intervention 1: Intervention group: Since the removal of the Foley catheter (about 20 days after the operation), in addition to strengthening the anterior muscles of the pelvic floor to control urinary incontinence,also the posterior tibial nerve stimulation will be used. Electrical stimulation of the posterior tibial nerve will be performed using Enraf ​​model 438 DYNATRON device made in the Netherlands. The characteristics of the current include: intensity of 0.5-10 mA, frequency of 20 Hz, pulse length of 200 microseconds, of course, the intensity of the current increases up to the threshold of motor nerve stimulation, which is characterized by flexion of the big toe. To perform electrical stimulation, the negative electrode (cathode) is placed behind the inner ankle on the left side of the body and the positive electrode (anode) is placed 10 cm above the cathode. The number of posterior tibial nerve stimulation sessions will be 12 sessions, 3 sessions each week and the duration of each session will be 30 minutes. Intervention 2: Intervention group: To control urinary incontinence, duloxetine and solifenacin tablets will be prescribed. Dose of Duloxetine, take 2 tablets of 20 mg daily (one every 12 hours) for 8 weeks and Sulifnacin one tablet (10 mg) daily after breakfast for 8 weeks. Yes - There is a plan to make this available What will be shared: All data can be shared except for authors names When: From 2026 onwards it is permissible To whom: Clinical professionals and Researchers in all fields Conditions: For treatment of patients and develop research and science Where to obtain: Correspond to the email address of the scientific responsible for the study How to obtain: Send and receive email Comments:
public Abbas Moradi
Shahid Fahmideh
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0557 a.moradi@umsha.ac.ir Hamedan University of Medical Sciences scientific Mohsen Alemi
Eram Blv
Hamadan Iran (Islamic Republic of) 6517953371 +98 81 3838 0704 mohsenalemi@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Total prostatectomy and urinary incontinence afterwards Declaration of consent to participate in the study no limit no limit Male Urinary tract infection during the treatment process History of previous surgery for urinary incontinence Recurrence of prostate cancer The presence of a pacemaker Inability to do Kegel exercises R32 Unspecified urinary incontinence Rehabilitation Treatment - Drugs Intervention group: Since the removal of the Foley catheter (about 20 days after the operation), in addition to strengthening the anterior muscles of the pelvic floor to control urinary incontinence,also the posterior tibial nerve stimulation will be used. Electrical stimulation of the posterior tibial nerve will be performed using Enraf ​​model 438 DYNATRON device made in the Netherlands. The characteristics of the current include: intensity of 0.5-10 mA, frequency of 20 Hz, pulse length of 200 microseconds, of course, the intensity of the current increases up to the threshold of motor nerve stimulation, which is characterized by flexion of the big toe. To perform electrical stimulation, the negative electrode (cathode) is placed behind the inner ankle on the left side of the body and the positive electrode (anode) is placed 10 cm above the cathode. The number of posterior tibial nerve stimulation sessions will be 12 sessions, 3 sessions each week and the duration of each session will be 30 minutes. Intervention group: To control urinary incontinence, duloxetine and solifenacin tablets will be prescribed. Dose of Duloxetine, take 2 tablets of 20 mg daily (one every 12 hours) for 8 weeks and Sulifnacin one tablet (10 mg) daily after breakfast for 8 weeks. Changes in the frequency of urinary incontinence. Timepoint: Before treatment, 4th and 8th week after treatment. Method of measurement: Asking the patient. Quality of life related to urinary incontinence. Timepoint: Before treatment, 4th and 8th week after treatment. Method of measurement: Questionnaire for evaluating the quality of life of patients with urinary incontinence. Side effects of treatment. Timepoint: 4th and 8th week after treatment. Method of measurement: Clinical examination and taking history from the patient. Hamedan University of Medical Sciences Approved 2024-09-14 Ethics committee of Hamadan Univercity of Medical Science Shahid Fahmideh Hamadan Hamadan Iran (Islamic Republic of)