Evaluation of the relationship between End to End anastomotic urethroplasty and erectile dysfunction in the patients with urethral stricture referred to Shohada E Tajrish Hospital during 2014-2017: Single blind randomized clinical trial
This study will be performed to evaluate the effect of end to end anastomotic urethroplasty on the sexual function in patients with urethral stricture. Inclusion criteria are consisted of: patients in active sexual age, patients with ability to follow up and candidate for this surgical procedure based on history, physical examination and radiographic and flexible cystoscopy findings. Exclusion criteria are consisted of: patients which will not have cooperation for follow up during performing the project, patients with endocrine disorders (Diabetes Mellitus, Thyroid dysfunction and dyslipidemia) and patients with hormonal disorders (such as testosterone and prolactin disorders). Population study are patients will undergo end to end anastomotic urethroplasty. Sampling is convenient and sample size will be 70 patients. All of patients will be undergo end to end urethroplasty in Shohada E Tajrish Hospital in Tehran during January 2016 till December 2017. Complete history, physical examination and complete laboratory data for sexual function will be fulfilled by questionnaire and patients checked by sexual function test questionnaire and color Doppler sonography of penile arteries before, 3 months and 6 months after surgery. Outcomes including radiographic findings to evaluate the pelvis fracture, site of urethral injury and perioperative bleeding, sexual function and color Doppler sonography of penile arteries will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021126513N1
Registration date:2016-05-10, 1395/02/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-10, 1395/02/21
Registrant information
Name
Morteza Fallahkarkan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3360 6767
Email address
karkan@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the relationship between End to End anastomotic urethroplasty and erectile dysfunction in the patients with urethral stricture referred to Shohada E Tajrish Hospital during 2014-2017: Single blind randomized clinical trial
Public title
Relationship between performing operation on urethra on sexual dysfunction in patients with urethral stricture
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: patients in active sexual age; patients with ability to follow up; candidate for this surgical procedure based on history, physical examination and radiographic and flexible cystoscopy findings.
Exclusion criteria: patients which will not have cooperation for follow up during performing the project; patients with endocrine disorders (Diabetes Mellitus, Thyroid dysfunction and dyslipidemia); patients with hormonal disorders (such as testosterone and prolactin disorders).
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
shahid beheshti medical university
Street address
velenjak
City
tehran
Postal code
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
IR.SBMU.SM.REC.1394.150
Health conditions studied
1
Description of health condition studied
Urethral Stricture
ICD-10 code
N37.8*
ICD-10 code description
Other urethral disorders in diseases classified elsewhere
Primary outcomes
1
Description
Erectile Dysfunction
Timepoint
Before, 3 and 6 months after surgery
Method of measurement
Penile color Doppler sonography with papaverine injection
Secondary outcomes
empty
Intervention groups
1
Description
Patients in one group will be assessed for indexes before and after End to End anastomotic urethroplasty.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada E Tajrish Hospital
Full name of responsible person
Behrooz Fadavi
Street address
Shohada E Tajrish Hospital, Tajrish Square, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Beside Taleghani Hospital, Shahid Abbas Erabi (Parvane) Street, Yaman Street, Shahid Chamran Highway, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
IR.SBMU.SM.REC.1394.150
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behruz Fadavi
Position
Urology Resident
Other areas of specialty/work
Street address
Shohada E Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 25719
Email
behruzfadavi@sbmu.ac.ir
Web page address
shmc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behruz Fadavi
Position
Urology Resident
Other areas of specialty/work
Street address
Shohada E Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 25719
Email
behruzfadavi@sbmu.ac.ir
Web page address
shmc.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behruz Fadavi
Position
Urology Resident
Other areas of specialty/work
Street address
Shohada E Tajrish Hospital, Tajrish Square, Tehran
City
Tehran
Postal code
1989934148
Phone
+98 21 25719
Fax
+98 21 25719
Email
behruzfadavi@sbmu.ac.ir
Web page address
shmc.sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)