Objectives: To determine the prevalence of urinary retention in post general anesthesia in cataract surgery and the effect of Tamsulosin in preventing this complication
Design and interventions: This clinical trial was carried out on 67 patients who had inclusion criteria of the study. They were divided randomly in two groups; the first group was consisted 32 patients received Tamsulosin and the other 35 subjects received placebo as control group.
Inclusion criteria: patients with spontaneous urine output less than 100 ml in the first eight hours after surgery, patients with abdominal discomfort and completely distended palpable bladder
Exclusion criteria: Congestive Heart Failure, Myocardial Infarction, Renal Failure, Hypotension (Systolic Blood Pressure less than 100 mmHg), hypersensitivity to the drug, IPSS score greater than 25 or less than 15 and patients with a permanently Foley catheter
Outcome variables: prevention of urinary retention after surgery
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111411469N1
Registration date:2013-02-11, 1391/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-11, 1391/11/23
Registrant information
Name
Arezou Karampourian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0572
Email address
a.karampourian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2010-07-21, 1389/04/30
Expected recruitment end date
2010-12-21, 1389/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to compare the efficacy Tamsulosin and placebo in prevention of urinary retention after general anesthesia in cataract surgery
Public title
Tamsulosin and preventing of postoperative urinary retention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : No contraindications for general anesthesia and general Surgery. Patients with spontaneous urine output less than 100 ml in the first eight hours after surgery, and completely distended palpable bladder
Exclusion criteria: Congestive Heart Failure, Myocardial Infarction, Renal Failure, Hypotension (Systolic Blood Pressure less than 100 mmHg), hypersensitivity to the drug, IPSS score greater than 25 or less than 15 and patients with a permanently Foley catheter
Age
From 52 years old to 84 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
67
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization was based on blocked simple randomization (each group was 6 patients). The study was single blind study, because physician awareness doesn't play any roll in patient's urinary retention but patient's awareness can affect the retention and patient can try to void and obscured the retention.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Shaheed Fahmideh St. Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Approval date
2007-05-05, 1386/02/15
Ethics committee reference number
15162/9/35/16/P
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H40.1
ICD-10 code description
Capsular glaucoma with pseudo exfoliation of lens (H40.1
Primary outcomes
1
Description
Urinary Retention
Timepoint
Every one hour, until 8 hours from surgery, patients will be examined for urination or probable urinary retention.
Method of measurement
Failure to void and patients need to urethra catheterization
Secondary outcomes
1
Description
Floppy Iris
Timepoint
During surgery
Method of measurement
Any iris dropping during surgery that report by surgeon and interfere with surgery
Intervention groups
1
Description
Intervention 1: Tablet Tamsulosin Hydrochloride 0.4 mg, once a day for four days, Brand name Flomax , manufacturer Farabi Pharmaceutical
Category
Prevention
2
Description
Intervention 2: Placebo
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Samavat Morteza
Street address
Farshchian Hospital, Mirzadeh Eshghi St., Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Tavilani Haydar
Street address
Shaheed Fahmideh St. Hamadan University of Medical Sciences
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for research, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Karampourian Arezo
Position
MSN/ Faculty member of Hamadan University of Medical Sciences
Other areas of specialty/work
Street address
Shaheed Fahmideh St. Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0572
Fax
Email
a.karampourian@umsha.ac ; karampor1@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Urology and Nephrology Research Center, Hamadan University of Medical Sciences
Full name of responsible person
Mousavi Bahar Seyed Habibollah
Position
Endourologic Surgeon
Other areas of specialty/work
Street address
Shaheed Fahmideh St. Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 83 80572
Fax
Email
shmbahar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shaheed Fahmideh St. Hamadan University of Medical Sciences
Full name of responsible person
Karampourian Arezo
Position
MSN/Faculty member of Hamadan University of Medical Sciences
Other areas of specialty/work
Street address
Shaheed Fahmideh St. Hamadan University of Medical Sciences
City
Hamadan
Postal code
6517838698
Phone
+98 81 1838 0572
Fax
Email
a.karampourian@umsha.ac.ir ; karampor1@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)