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IRCT20200429047243N1 IRCT 2020-05-05 Shahid Beheshti University of Medical Sciences Comparison the Effect of Pelvic Floor Muscle Biofeedback prior or post Radical Prostatectomy on Urinary Incontinence Comparison the Effect of Pelvic Floor Muscle Biofeedback prior or post Radical Prostatectomy on Urinary Incontinence: A Randomized Clinical Trial 2019-09-23 anticipated 60 Complete https://irct.ir/trial/47616 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Single, Purpose: Supportive, Randomization description: Patients will be randomized in to three groups by a randomization software and then sealed envelope. simple randomization and individual randomization applied. Sequentially numbered, sealed, opaque envelopes will use for allocation concealment, Blinding description: In this single blinded study, patients will be blinded by using functional biofeedback probe in the case groups whereas the control group receives nonfunctional probes. N/A Neuromuscular dysfunction of bladder, unspecified. Intervention 1: Intervention group: biofeedback prior to radical prostatectomy. Intervention 2: Intervention group: biofeedback after radical prostatectomy. Intervention 3: Control group: no biofeedback. Yes - There is a plan to make this available What will be shared: only a fraction of data consisting of primary outcome will be shared. When: data will become available three months after publication. To whom: only people working in academic institutions will have access to these data. Conditions: further statistical analysis on the data is permitted. Where to obtain: applicants can contact us on E-mial: saeed. montazeri89@gmail.com How to obtain: After consultation with other researchers, decision will be made for data sharing. this procedure should not take more than two months. Comments: No comment
public Saeed Montazeri
Tehran- tajrish- shohadaye tajrish hospital
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8006 saeed.montazeri89@gmail.com Shahid Beheshti University of Medical Sciences scientific Saeed Montazeri
Tehran Province, Tehran, District 1, Tajrish square, shohadaye tajrish hospital
tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8006 saeed.montazeri89@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Men with prostate cancer confirmed with TRUSBx who are candidates for radical prostatectomy no limit no limit Male patients who were diagnosed with prostate cancer following Transurethral Resection of Prostate patients who received pelvic radiotherapy regardless of their primary malignancy spinal cord injury comorbidities that can affect urinary continence (such as: diabetes mellitus, overactive bladder, urethral stricture, etc.) history of pelvic or retroperitoneal surgery neurologic disorders (e.g.: Multiple Sclerosis, seizures, etc.) N31.9 Neuromuscular dysfunction of bladder, unspecified , prostate cancer Rehabilitation Rehabilitation Rehabilitation Intervention group: biofeedback prior to radical prostatectomy Intervention group: biofeedback after radical prostatectomy Control group: no biofeedback Biofeedback before radical prostatectomy on urinary incontinence after surgery according to King's Health Questionnaire. Timepoint: before surgery and 1,3 and 6 months after surgery. Method of measurement: King's Health Questionnaire. Shahid Beheshti University of Medical Sciences Approved 2018-08-11 urology and nephrology research center pasdaran street, boustan 9th, between eslami and paydarfard street tehran Tehran Iran (Islamic Republic of)