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IRCT20151028024751N1 IRCT 2021-08-17 Shahid Beheshti University of Medical Sciences Male stress urinary incontinence after radical prostatectomy SUI The evaluation of an integrated physical therapy protocol on male stress urinary incontinence after radical prostatectomy 2021-10-07 anticipated 60 Complete https://irct.ir/trial/57852 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patient divided into three random group by a random number generator. the process would be done for every person and by simple randomization process. To randomize participants their names will be inserted into the Excel application. Then by using rand function a random number will be assigned to every participant. Then this number will be sort by application from the highest to lowest that this action will disorient the list and randomize participants placement in list. Then first 20 participants in list will be in integrated therapy group and second 20 participants in list will be in pelvic floor muscle exercise group and last 20 participants in list will be in control group. Randomize process will be done by statistics Advisor and groups will be assigned base on number 1 for integrated therapy group , number 2 for pelvic floor muscle group exercise and number 3 control group, Blinding description: The participated patients would not know that if they are in the treatment groups or control group. Control group would receive sham electrotherapy without any current. Analyzer receive patients group detail by number 1-3 and would not know about groups situation. N/A Male urinary stress incontinence. Intervention 1: Control group: control group (sham electrotherapy) For this group sham electrotherapy will be done for 12 sessions in 4 weeks. Electrodes will be placed at lower abdominal (above inguinal ligament) and higher one third of thigh in the medial side but no current would be applied to them. after the data collection at the end of the study the approach that had the best outcome (pelvic floor muscle exercise or integrated therapy) will be done for this group too. Intervention 2: Intervention group: integrated therapy . For this group 12 session of integrated therapy will be done in 4 weeks. In this treatment electrotherapy will be done first with interferential current that electrodes will be placed at lower abdominal (above inguinal ligament) and higher one third of thigh in the medial side and 0-100 Hz frequency for 15 minutes. An interferential 520 p plus model 2020 made in Iran will be used to apply this current. Then manual therapy (neuromuscular therapy technique) will be done for iliopsoas and diaphragm muscles. Then exercise therapy for diaphragmatic breathing exercise, Knack exercise, Kegel exercise and pelvic floor muscles synergies exercise ( gluteus maximus and medius , multifidus and abdominal muscles) will be done. In the first session these exercises will be taught to patient then in the later sessions patient exaction of this exercises will be monitored by therapist. Sets , number and intensity of this exercises for home will be instruct based on patient status by therapist. Also, an instruction manual will be provided to patient for this exercises to this exercises correctly. Intervention 3: Intervention group: Pelvic floor muscle exercises. For this group 12 session of exercise therapy for Knack exercise, Kegel exercise and pelvic floor muscles synergies exercise ( gluteus maximus and medius , multifidus and abdominal muscles) will be done in 4 weeks. In the first session these exercises will be taught to patient then in the later sessions patient exaction of this exercises will be monitored by therapist. Sets , number and intensity of this exercises for home will be instruct based on patient status by therapist. Also, an instruction manual will be provided to patient for this exercises to this exercises correctly. Yes - There is a plan to make this available What will be shared: All of this study data could be shared after making it unrecognizable. When: Data would be shared one month after publication. To whom: This data only assessable for academic researchers. Conditions: There is no specific qualification for using this study data. Where to obtain: To receive this study data please contact Dr.Farshad Okhovatian. phone:00982177561721 fax:00982177561721 email:okhovatianf@sbmu.ac.ir address: Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences. How to obtain: Only a request letter would be enough for receiving data. Comments:
public Farshad Okhovatian
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 okhovatianf@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Farshad Okhovatian
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 okhovatianf@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Stress urinary incontinence secondary to radical prostatectomy surgery diagnosed by urologist Age between 50 to 80 50 years 80 years Male Major neurological problems such as Parkinson, Multiple sclerosis and central nervous system anomalies Major orthopedic problems in spine and pelvic Using duloxetine or similar drugs that have a similar effect on incontinence Uncontrolled diabetes or other peripheral nerve system diseases that cause sensation problem Any pervious rehabilitation treatment for incontinence after last surgery Skin inflammation, thrombosis or pacemaker R32 Unspecified urinary incontinence Placebo Rehabilitation Rehabilitation Control group: control group (sham electrotherapy) For this group sham electrotherapy will be done for 12 sessions in 4 weeks. Electrodes will be placed at lower abdominal (above inguinal ligament) and higher one third of thigh in the medial side but no current would be applied to them. after the data collection at the end of the study the approach that had the best outcome (pelvic floor muscle exercise or integrated therapy) will be done for this group too. Intervention group: integrated therapy . For this group 12 session of integrated therapy will be done in 4 weeks. In this treatment electrotherapy will be done first with interferential current that electrodes will be placed at lower abdominal (above inguinal ligament) and higher one third of thigh in the medial side and 0-100 Hz frequency for 15 minutes. An interferential 520 p plus model 2020 made in Iran will be used to apply this current. Then manual therapy (neuromuscular therapy technique) will be done for iliopsoas and diaphragm muscles. Then exercise therapy for diaphragmatic breathing exercise, Knack exercise, Kegel exercise and pelvic floor muscles synergies exercise ( gluteus maximus and medius , multifidus and abdominal muscles) will be done. In the first session these exercises will be taught to patient then in the later sessions patient exaction of this exercises will be monitored by therapist. Sets , number and intensity of this exercises for home will be instruct based on patient status by therapist. Also, an instruction manual will be provided to patient for this exercises to this exercises correctly. Intervention group: Pelvic floor muscle exercises. For this group 12 session of exercise therapy for Knack exercise, Kegel exercise and pelvic floor muscles synergies exercise ( gluteus maximus and medius , multifidus and abdominal muscles) will be done in 4 weeks. In the first session these exercises will be taught to patient then in the later sessions patient exaction of this exercises will be monitored by therapist. Sets , number and intensity of this exercises for home will be instruct based on patient status by therapist. Also, an instruction manual will be provided to patient for this exercises to this exercises correctly Incontinence episode. Timepoint: daily. Method of measurement: bladder diary questionnaire. Quality of life. Timepoint: monthly. Method of measurement: SF12 questionnaire. Urination frequency. Timepoint: daily. Method of measurement: bladder diary questioner. Fluid intake. Timepoint: daily. Method of measurement: Calibrated container. Urination amount. Timepoint: daily. Method of measurement: Calibrated container. Shahid Beheshti University of Medical Sciences Approved 2021-03-09 Ethics committee of shahid Beheshti university of medical sciences 7th Floor, Bldg No.2 SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran تهران Tehran Iran (Islamic Republic of)