Protocol summary
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Study aim
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The effect of low-intensity shock waves (LI-ESWT) in improving erectile function in patients with erectile dysfunction not responding to PDE-5 inhibitors
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Design
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The study will be performed as an open clinical trial without blindness
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Settings and conduct
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The study will be performed in a private urology clinic in Rasht. The study will be performed as an open clinical trial without blindness...
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age more than 40 years; lack of therapeutic response to phosphodiesterase inhibitors 5.
Exclusion criteria: history of psychological disorders based on the Beck standard questionnaire; history of previous radical prostatectomy; history of pelvic radiotherapy; history of malignancy in the last five years; use of anti-androgens, anticoagulants, thiazides, non-specific antiblockers, opioids and drugs; coronary artery disease; heart failure.
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Intervention groups
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Intervention group: Low-intensity shock waves (LI-ESWT) with energy density of 0.160 mJ/mm2 and 6HZ-8HZ frequencies and the total number of 6000 shock, once a week for six consecutive weeks
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Main outcome variables
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International Index of Erectile Function
General information
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Reason for update
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Due to the fact that in the past, the preliminary steps to register a clinical trial in the system started earlier than receiving the ethics approvals, and by taking the approval code, the steps were completed and the proposal was sent, and sometimes it took several months to register in IRCT, so the expected date for starting the study was sometimes much earlier than the due date for it.This project also started about 14 months after the expected date due to financial problems and many improvements in the implementation method. Currently, to prepare the article, it is necessary to modify the dates of start and finish in the system.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201710024582N6
Registration date:
2017-11-05, 1396/08/14
Registration timing:
prospective
Last update:
2022-06-07, 1401/03/17
Update count:
1
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Registration date
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2017-11-05, 1396/08/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Urology Research Center, Guilan University of Medical Sciences
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Expected recruitment start date
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2016-06-21, 1395/04/01
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Expected recruitment end date
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2017-09-23, 1396/07/01
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Actual recruitment start date
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2017-11-07, 1396/08/16
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Actual recruitment end date
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2018-07-23, 1397/05/01
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Trial completion date
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2018-08-23, 1397/06/01
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Scientific title
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The effect of low-intensity shock waves (LI-ESWT) in improving erectile function in patients with erectile dysfunction not responding to PDE-5 inhibitors
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Public title
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The effect of low-intensity shock waves (LI-ESWT) in patients with erectile dysfunction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age more than 40 years;
passing more than 6 months from the onset of the disease;
having a stable sex in the last three months;
lack of therapeutic response to phosphodiesterase inhibitors 5;
lack of experience in the use of drugs or non-medical therapies for the treatment of erectile dysfunction in the last three months
Exclusion criteria:
history of psychological disorders based on the Beck standard questionnaire;
history of neurological diseases;
history of previous radical prostatectomy;
history of pelvic radiotherapy;
history of malignancy in the last five years;
use of anti-androgens, anticoagulants, thiazides, non-specific antiblockers, antipsychotics, antidepressants , anxiolytics, opioids and drugs;
alcohol abuse;
severe lower urinary tract symptoms (LUTS);
history of urethritis;
coronary artery disease;
heart failure;
thyroid disorders;
penile or urethra anomalies
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Age
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From 40 years old to 139 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
128
Actual sample size reached:
128
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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The study will be performed as an open clinical trial without blindness.
Ethics committees
1
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Ethics committee
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Approval date
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2016-06-21, 1395/04/01
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Ethics committee reference number
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IR.GUMS.REC.1395.106
Health conditions studied
1
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Description of health condition studied
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Erectile dysfunction
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ICD-10 code
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F52.2
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ICD-10 code description
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Failure of genital response
Primary outcomes
1
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Description
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International Index of Erectile Function
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Timepoint
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Before intervention, at the end of intervention, 3 and 6 months after intervention
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Method of measurement
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The International Index of Erectile Function (IIEF) questionnaire
Intervention groups
1
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Description
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Low-intensity shock waves (LI-ESWT) with energy density of 0.160 mJ/mm2 and 6HZ-8HZ frequencies and the total number of 6000 shock, once a week for six consecutive weeks
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Urology Research Centre, Guilan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available