Aim of this study is to assess preventive effect of Tamsulosin on postoperative urinary retention and obstructive urinary symptoms in colporrhaphy surgery. This study is clinical trial and double blind.
Inclusion criteria: less than 60 years; indications for colporrhaphy surgery; lack of active urinary tract infection; lack of history of neurological disorders; lack of malignancy; lack of urinary incontinence; don't use of drugs affecting the performance of urination; lack of urology disorder;lack of history of urinary stones or urinary obstruction;don’t urinary catheter fixed; don't history of chronic kidney disease; don't history of cardiopulmonary disorders; don't history of allergy to Tamsulosin; don't history of treatment and use Tamsulosin.
Exclusion criteria: Lack of access to patient for any reason during the first 24 hours after surgery.
We will divide patients in 2 group after complete demographic information (age and gender). We will prescribe 0.4 milligram Tamsulosin one dose at 12 PM o'clock after surgery in 65 patients. We will prescribe placebo to control group. We will examine difficulty in urination or retention in 24 hours after surgery by clinical response.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042720258N42
Registration date:2017-04-29, 1396/02/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-29, 1396/02/09
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor and Research ,Arak University of Medical Sciences
Expected recruitment start date
2017-02-07, 1395/11/19
Expected recruitment end date
2018-03-10, 1396/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of tamsulosin on postoperative urinary retention and obstructive urinary symptoms in colporrhaphy surgery
Public title
Preventive effect of tamsulosin on postoperative urinary retention and obstructive urinary symptoms in colporrhaphy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:less than 60 years; Indications for colporrhaphy surgery; lack of active urinary tract infection; lack of history of neurological disorders; lack of malignancy; lack of urinary incontinence; don't use of drugs affecting the performance of urination; lack of urology disorder;lack of history of urinary stones or urinary obstruction;don’t urinary catheter fixed; don't history of chronic kidney disease; don't history of cardiopulmonary disorders; don't history of allergy to Tamsulosin; don't history of treatment and use Tamsulosin.
Exclusion criteria: Lack of access to patient for any reason during the first 24 hours after surgery.
Age
To 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Dr Mohammad Rafie, Vice Chancellor Research, Payambar Azam complex, Basij square, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2017-02-06, 1395/11/18
Ethics committee reference number
IR.ARAKMU.REC.1395.381
Health conditions studied
1
Description of health condition studied
Urinary retention
ICD-10 code
R33
ICD-10 code description
Retention of urine
Primary outcomes
1
Description
urinary retention
Timepoint
24 hour after surgery
Method of measurement
clinical response
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We will prescribe 0.4 milligram Tamsulosin one dose at 12 PM o'clock after surgery
Category
Treatment - Drugs
2
Description
Control group: We will prescribe placebo at 12 PM o'clock to control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokpour
Street address
Taleghani hospital, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor For Research, Arak University of Medical Sciences