The objective of this study is to survey the effect of Tamsolosine in the prevention of Postoperative Urinary Retention (PUR). In this randomized double blind clinical trial, 222 men aged 18 to 50 years old admitted in urology ward of Razi educational center, for scrotal surgery, varicocelectomy, or herniorrhaphy were randomly assigned into the intervention or control group. The patients in the intervention group will receive 3 doses of tamsulosine capsule, 0.4mg orally (2 dose during 14 and 2 hours prior to the surgery and one dose 10 hours after the surgery). The patients in the control group will receive 3 doses of placebo with the same shape as the active capsules. The prevalence of urinary retention after the surgery will be compared between groups during the first 24 hours after the surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109084582N5
Registration date:2011-11-27, 1390/09/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-11-27, 1390/09/06
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
2011-08-30, 1390/06/08
Expected recruitment end date
2012-08-29, 1391/06/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of tamsulosin with placebo in prevention of urinary retention after scrotal surgeries, varicocelectomy and herniorrhaphy
Public title
Comparison of effectiveness of tamsulosin with placebo in prevention of urinary retention after scrotal surgeries, varicocelectomy and herniorrhaphy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: men with 18-50 that underwent spinal anesthesia with 2cc lidocaine for scrotal surgery, varicocelectomy or herniorrahphy and duration of their surgery are less than 90 min
Exclusion criteria: urinary symptom before surgery, history of urinary retention, history of neurologic disease, pelvic surgery history, history of benzodiazepine consumption, beta agonist and alpha agonist before surgery, IV fluid intake during surgery more than 1500cc, use of anesthetic drugs except for lidocaeine for spinal anesthesia and duration of surgery more than 90 min
Age
From 18 years old to 50 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
222
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
Guilan University of Medical Sciences
Street address
Razi Hospital
City
Rasht
Postal code
41448-95655
Approval date
2011-10-04, 1390/07/12
Ethics committee reference number
1900963801
Health conditions studied
1
Description of health condition studied
Urinary retention
ICD-10 code
N31.9
ICD-10 code description
Neuromuscular dysfunction of bladder, unspecified
Primary outcomes
1
Description
urinary retention
Timepoint
during 24 hours after surgery
Method of measurement
Medical history, physical examination, urine volume after catheterization
Secondary outcomes
empty
Intervention groups
1
Description
3 dose of tamsulosine capsule 0.4mg orally (2 dose during 14 and 2 hours before surgery and one dose 10 hours after surgery)
Category
Treatment - Drugs
2
Description
3 dose of placebo orally (2 dose during 14 and 2 hours before surgery and one dose 10 hours after surgery)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Hamidreza Baghani Aval
Street address
Sardar Jangal Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan Urology Research Center
Full name of responsible person
Dr. Siavash Falahatkar, Director of Urology Research Center
Street address
Urology Research Center, Razi Hospital
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan Urology Research Center
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
Full name of responsible person
Dr. Hamidreza Baghani Aval
Position
Resident of Urology
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
www.urology.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Dr. Ali Hamidi Madani
Position
Associate Professor
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
www.urology.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center
Full name of responsible person
Samaneh Esmaeili
Position
Urology Research Center secreter/ Bachlor
Other areas of specialty/work
Street address
Urology Research Cente, Razi Hospital
City
Rasht
Postal code
41448-95655
Phone
+98 13 1552 5259
Fax
+98 13 1552 5259
Email
urc1384@yahoo.com
Web page address
www.urology.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)