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IRCT20170716035104N3 IRCT 2019-04-22 Esfahan University of Medical Sciences The effect of Kegel training on quality of life and urinary incontinence after radical prostatectomy The effect of pelvic floor muscle exercises (Kegel training) on improving patient’s quality of life and urinary incontinence after radical prostatectomy 2016-06-30 anticipated 80 Complete https://irct.ir/trial/38778 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done using "Simple Random Sampling" method and random value creation between zero and one in SPSS software. To allocate random values to the intervention group or control group a value less than or equal to 0.5 is assigned to the control group and values greater than 0.5 are assigned to the intervention group by sortition, Blinding description: Participants will not be informed about the group they are dedicated to (intervention or control). Moreover, clinical caregivers will not be informed about the patient's group (intervention or control). Researcher and the outcome evaluators will not be blinde due to the necessity for patient follow-up. N/A Prostate cancer. Intervention 1: The intervention group receives lessons on Kegel training with the biofeedback technique by a physiotherapist during a one-hour training session, and they are also given a home exercise schedule. For one month, these patients will do the exercises at home each day. Patients undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge. Then the control group will continue these exercises within six months (after the removal of their urinary catheter the day after the operation until the sixth month after the removal of their catheter). Intervention 2: The control group would undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge, but they receive no intervention. Yes - There is a plan to make this available What will be shared: The data of the participants, which includes demographic data and the primary outcome variables of the study, exists in data files that can be shared after individuals were unidentified. When: Data will be available from March 2021. To whom: Researchers working in universities or scientific institutions Conditions: The data will be available for more advanced statistical analysis and review with the official permission of the Vice-Chancellor of Research of Isfahan University of Medical Sciences. Where to obtain: To obtain official permission to access the data, the applicant must refer to the Office of the Vice-Chancellor of Research of Isfahan University of Medical Sciences in Isfahan, Iran. How to obtain: First, the applicant will apply for access to the data by referring to the Office of the Vice-Chancellor of Research of Isfahan University of Medical Sciences. Then the request will be processed by the Vice-Chancellor of the Isfahan University of Medical Sciences and, if deemed appropriate, the applicant will be allowed access to the information. In the next step, the applicant refers to the Research Office of the University and the data will be provided to him/her. This process may take a period of one to two months. Comments:
public Mohammad Hatef Khorrami
Urology department, Al-Zahra hospital, Soffe Blvd., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 khorami386@gmail.com Esfahan University of Medical Sciences scientific Mohammad Hatef Khorrami
Urology department, Al-Zahra hospital, Soffe Blvd., Isfahan, Iran.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5555 khorami386@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Age between 50 and 75 years old Being a candidate for prostatectomy surgery Informed consent for participation in the study 50 years 75 years Male Presence of Diabetes mellitus Neurological deficits Psychological deficits Having severe urinary incontinence prior to the surgical intervention Age over 75 years due to the high prevalence of geriatric incontinence and severe pelvic floor muscle breakdown Unavailability of the patient or the inability to follow the patient Patient's death after surgery Admission to ICU due to grade 3 and 4 post-operative complications C79.1 Secondary malignant neoplasm of bladder and other and unspecified urinary organs Rehabilitation Rehabilitation The intervention group receives lessons on Kegel training with the biofeedback technique by a physiotherapist during a one-hour training session, and they are also given a home exercise schedule. For one month, these patients will do the exercises at home each day. Patients undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge. Then the control group will continue these exercises within six months (after the removal of their urinary catheter the day after the operation until the sixth month after the removal of their catheter). The control group would undergo radical prostatectomy, and standardized postoperative approaches will be considered for them until discharge, but they receive no intervention. International Consultation on Incontinence Questionnaire. Male Lower Urinary Tract Symptoms long form questionnaire scores. Timepoint: One day, one week, one month, three months and six months after the surgery. Method of measurement: Evaluating the questionnaire scores. Esfahan University of Medical Sciences Approved 2017-06-03 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)