The effect of Povidone-Iodine enema in the incidence of infectious complications following prostate needle biopsy in patients suspicious for prostate cancer and comparison with control group
The aim of this clinical trial is to evaluate the effect of Povidone-Iodine enema in the incidence of infectious complications following prostate needle biopsy. 120 patients who are referred to the Urology department of Imam Reza Hospital, Mashhad due to abnormal prostate in digital rectal exam (DRE) or increase in prostate specific antigen (PSA) for biopsy of the prostate are divided randomly into two equal groups. After obtaining informed consent, the case group receive an intrarectal mixture of povidone-iodine and lidocaine gel before performing biopsy, while the control group receive only lidocaine gel. Rectal swab specimens obtain before and after biopsy and will send for culture. Patients are followed weekly up to 30 days for possible signs of infection or hospital readmission.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092429935N1
Registration date:2017-11-13, 1396/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-13, 1396/08/22
Registrant information
Name
Seyedalireza Ghoreifinejadian
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3885
Email address
ghoreifina@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-06-07, 1396/03/17
Expected recruitment end date
2018-11-29, 1397/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Povidone-Iodine enema in the incidence of infectious complications following prostate needle biopsy in patients suspicious for prostate cancer and comparison with control group
Public title
The effect of Povidone-Iodine enema in the incidence of infectious complications following prostate needle biopsy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Men who refer to the Urology department of Imam Reza Hospital, Mashhad due to abnormal prostate in digital rectal exam (DRE) or increase in prostate specific antigen (PSA) for biopsy of the prostate , Obtaining informed consent
Exclusion Criteria: No informed consent
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreishi Building, Daneshgah St
City
Mashhad
Postal code
Approval date
2017-06-07, 1396/03/17
Ethics committee reference number
IR.MUMS.fm.REC.1395.645
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
infectious complications
Timepoint
evey week to 30 days
Method of measurement
History and Phusical exam
Secondary outcomes
1
Description
Rectal Culture
Timepoint
Before and after biopsy
Method of measurement
Rectal swab
Intervention groups
1
Description
Rectal enema with 50 cc mixture of Povidone-Iodine and lidocaine jelly before biopsy in case group
Category
Prevention
2
Description
Rectal enema with 50 cc lidocaine jelly before biopsy in control group
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Department, Imam Rea Hospital
Full name of responsible person
Seyedalireza Ghoreifinejadian
Street address
Urology Department, Imam Reza Hospital
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Eslami
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Seyedalireza Ghoreifinejadian
Position
Assistant Professor of Urology
Other areas of specialty/work
Street address
Urology Department, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3858 3885
Fax
Email
ghoreifina@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedalireza Ghoreifinejadian
Position
Assistant Professor of Urology
Other areas of specialty/work
Street address
Urology Department, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3858 3885
Fax
Email
ghoreifina@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyedalireza Ghoreifinejadian
Position
Assistant Professor of Urology
Other areas of specialty/work
Street address
Urology Departmrnt, Imam Reza Hospital
City
Mashhad
Postal code
Phone
+98 51 3858 3885
Fax
Email
ghoreifina@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)