The effect of low-intensity shock waves (LI-ESWT) in improving erectile function in patients with erectile dysfunction not responding to PDE-5 inhibitors
Erectile dysfunction has a high prevalence and many harmful physical psychosomatic and psychosocial effects, and has a devastating impact on the quality of life of the patient and his sexual partner. Common therapies, in spite of the relative effect, are often sectional and therefore have no long-term and certain effects. Side effects and invasiveness of some methods are other disadvantages of common treatments. In this clinical trial, the impact of a new and less invasive treatment, called low-intensity shock waves (LI-ESWT), on 128 men over 40 years of age with erectile dysfunction with no response to phosphodiesterase type 5 inhibitors will be investigated.
Patients with a history of psychological disorders based on Beck's standard questionnaire, history of neurological diseases, history of previous radical prostatectomy and pelvic radiotherapy will be excluded from the study. At first, the standard Beck Questionnaire will be completed for all patients to exclude patients with psychological disorders. Then, the severity of erectile dysfunction in participants will be determined by the standard IIEF questionnaire. Afterwards, patients will be subjected to LI-ESWT once a week for six consecutive weeks by a single operator using the Richard wolf GmbH-Germany(Piezowave2) device. The energy density used is 0.160 mJ/mm2 and its frequency is 6HZ-8HZ and the total number is 6000 shock. Each time, 2000 waves of shock are applied to the corpus cavernosome of each side and 1000 waves to the curves of the two sides. After completion of treatment, patients will be asked by face-to-face interview or telephone for possible side effects. Again, the IIFF score will be calculated after the completion of the course, three and six months after treatment. The treatment success threshold will be considered to be at least 5 points increase in the IIEF questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710024582N6
Registration date:2017-11-05, 1396/08/14
Registration timing:retrospective
Last update:
Update count:1
Registration date
2017-11-05, 1396/08/14
Registrant information
Name
Ali Hamidi Madani
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1552 5259
Email address
hamidimadani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low-intensity shock waves (LI-ESWT) in improving erectile function in patients with erectile dysfunction not responding to PDE-5 inhibitors
Public title
The effect of low-intensity shock waves (LI-ESWT) in patients with erectile dysfunction
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 139 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The study will be performed as an open clinical trial without blindness.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite of Sepah Bank, west Shahid Beheshti Blvd., Gas Sq., Rasht
City
Rasht
Postal code
41938-93345
Approval date
2016-06-21, 1395/04/01
Ethics committee reference number
IR.GUMS.REC.1395.106
Health conditions studied
1
Description of health condition studied
Erectile dysfunction
ICD-10 code
F52.2
ICD-10 code description
Failure of genital response
Primary outcomes
1
Description
International Index of Erectile Function
Timepoint
Before intervention, at the end of intervention, 3 and 6 months after intervention
Method of measurement
The International Index of Erectile Function (IIEF) questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Mahmoud Shabanipour
Street address
Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Head of Urology Research Centre, Dr. Siavsh Falahatkar
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Mahmoud Shabanipour
Position
Resident of Urology/ Co worker
Other areas of specialty/work
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
mahmood19802003@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Urologist / Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
a.hamidimadani@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Master Degree/ Researcher of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street, Rasht
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)