Purpose of study: The assessment of effect of betadine on prevention of UTI after prostate biopsy; Study design: interventional; Method: The patients will be randomized into two groups. 1- In interventional group Betadine Vaginal Gel 10% (Povidone Iodine; 80g ) with Gavage Syringe is injected into the rectum and after 5 minutes prostate biopsy will be performed. 2- In control group patients will not receive betadine before prostate biopsy. 48h after the biopsy UA and UC will be obtained from patients and fever of the patients will be evaluated. The results of study in this two groups will be compared with together; Inclusion criteria: All patients that candidate for transrectal ultrasound-guided prostate biopsy who referred to Shahid Hasheminejad Hospital; Exclusion criteria: Unable to follow-up patients; Presence of abnormal UA and UC before Prostate biopsy; Unable to use local antiseptic; Previous prostatectomy; Intervention: Drug (Betadine); Target sample size: 300; Primary outcome measure: Acute prostatitis
General information
Acronym
_
IRCT registration information
IRCT registration number:IRCT201201038605N1
Registration date:2012-04-04, 1391/01/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-04, 1391/01/16
Registrant information
Name
Soodabeh Nikfarjam
Name of organization / entity
Tehran University of Medical Sciences (Pardise Hemmat)
Country
Iran (Islamic Republic of)
Phone
+98 21 2219 2705
Email address
s_nikfarjam@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-10-06, 1391/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of effect of local antiseptic on UTI in the cases of transrectal ultrasound-guided prostate biopsy
Public title
The effect of betadine on prevention of UTI after prostate biopsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients that candidate for transrectal ultrasound-guided prostate biopsy who referred to Shahid Hasheminejad Hospital; Exclusion criteria: Unable to follow-up patients; Presence of abnormal UA and UC before Prostate biopsy; Unable to use local antiseptic; Previous prostatectomy
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
_
Secondary Ids
1
Registry name
_
Secondary trial Id
_
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences (Pardise Hemmat)
Street address
Medical school, near Milad hospital, Shahid Hemmat freeway
City
Tehran
Postal code
_
Approval date
2011-03-13, 1389/12/22
Ethics committee reference number
1372
Health conditions studied
1
Description of health condition studied
acute prostatitis
ICD-10 code
N41.0
ICD-10 code description
Acute prostatitis
Primary outcomes
1
Description
acute prostatitis
Timepoint
48 hours after intervention
Method of measurement
U/A+U/C+Temperature of body
Secondary outcomes
1
Description
nothing
Timepoint
nothing
Method of measurement
nothing
Intervention groups
1
Description
Control:In this group without injection of betadine in the rectum prostate biopsy will be performed
Category
N/A
2
Description
intervention: Betadine Vaginal Gel 10% (Povidone Iodine; 80 g ) with Gavage Syringe is injected into the rectum and after 5 minutes prostate biopsy will be performed
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Hasheminejad Hospital
Full name of responsible person
Dr Seyed Morteza Bagheri, Radiologist
Street address
Shahid Valinejad avenue, The North of Vanak square, Vali Asr street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences (Pardise Hemmat)
Full name of responsible person
Dr Seyed Morteza Bagheri
Street address
Tehran University of Medical Sciences (Pardise Hemmat), near Milad Hospital, Shahid Hemmat freeway
City
Tehran
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences (Pardise Hemmat)
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
Tehran University of Medical sciences (Pardise Hemmat)
Full name of responsible person
Soodabeh Nikfarjam
Position
Student of Radiology
Other areas of specialty/work
Street address
Medical School, near Milad Hospital, Shahid Hemmat freeway
City
Tehran
Postal code
_
Phone
+98 21 8860 2216
Fax
_
Email
s_nikfarjam@razi.tums.ac.ir
Web page address
_
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical sciences (Pardise Hemmat)
Full name of responsible person
Soodabeh Nikfarjam
Position
student of radiology
Other areas of specialty/work
Street address
Medical School, near Milad Hospital, Shahid Hemmat freeway
City
Tehran
Postal code
_
Phone
+98 21 8860 2216
Fax
_
Email
s_nikfarjam@razi.tums.ac.ir
Web page address
_
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical sciences (Pardise Hemmat)
Full name of responsible person
Soodabeh Nikfarjam
Position
Student of Radiology
Other areas of specialty/work
Street address
Medical School, near Milad Hospital, Shahid Hemmat freeway
City
Tehran
Postal code
_
Phone
+98 21 8860 2216
Fax
_
Email
s_nikfarjam@razi.tums.ac.ir
Web page address
_
Sharing plan
Deidentified Individual Participant Data Set (IPD)