Our aim in this study was the assessing of Tamsulosin efficacy as an α -1A-specific Blocker in improving the success rate in ureteroscopic lithotripsy for lower ureteral stones. we included 102 patients with lower uerter single opaque stone in 5-10 milimeters sizes. All patients with multiple, mid or upper ueter stones excluded from study. The patients were randomly divided into 2 groups: study (52 patients) received tamsulosin with our traditional treatment (hydration and analgesic when required), while control (50 patients) received placebo with traditional treatment,all of patients underwent urteroscopic lithotripsy by one urologist. The number of colic episodes, lower urinary tract symptoms, analgesic dosage, and days for spontaneous passage of the stones through the ureter were recorded after lithotripsy by diary. The results of this study showed that administration of α -1A-specific blockers will reduce analgesic dosage and colic episodes and rate of adverse effects after ureteroscopic lithotripsy of lower ureteral stones and decrease gravel expulsion time after ureteroscopic lithotripsy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212261981N2
Registration date:2013-03-13, 1391/12/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-13, 1391/12/23
Registrant information
Name
Ali Asghar Ketabchi
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 4348
Email address
a_ketabchi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physiology Research Center ,Kerman University of Medical Science
Expected recruitment start date
2008-06-01, 1387/03/12
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Tamsulosin, an alpha-1 receptor antagonist in ureteroscopic lithotripsy (URSL) success rate
Public title
The effect of Tamsulosin in facilitation of gravel expulsion after ureteroscopic lithotripsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:lower ureter stone ; single stone ; radio opaque stone ; 5-10 mm diameter stone
Exclusion criteria: urinary tract infections;high-grade hydronephrosis; diabetes;hypersensitivity to α -blockers; ureteral stricture;pregnant women
Age
From 17 years old to 36 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
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
Kerman University of Medical Science Research Center
Street address
Kerman University of Medical Science
City
Kerman
Postal code
Approval date
2013-01-06, 1391/10/17
Ethics committee reference number
Ka/91/285
Health conditions studied
1
Description of health condition studied
Distal ureter stones
ICD-10 code
N20-N23
ICD-10 code description
Urolithiasis
Primary outcomes
1
Description
success rate of ureteroscopic lithotripsy( stone clearance)
Timepoint
2 weeks
Method of measurement
imaging methods
Secondary outcomes
1
Description
complications
Timepoint
from start of procedure until 2 weeks
Method of measurement
by questinerie and imaging
Intervention groups
1
Description
In control group one 0.4 mg placebo capsule daily ( like tamsulosin) orally for 2 weeks
Category
Treatment - Drugs
2
Description
In study group one 0.4 mg tamsulosin capsule daily orally for 2 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital ( urology department)
Full name of responsible person
Dr.Ali Asghar Ketabchi
Street address
Bahonar Hospital ( urology department)
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physiology Research Center , Kerman University of Medical ُُSciences
Full name of responsible person
Dr. Hamid Najafi
Street address
Research Building, Somaie Square
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physiology Research Center , Kerman 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
Kerman University of Medical Science
Full name of responsible person
Dr.Ali Asghar Ketabchi
Position
Urology Associate Professor
Other areas of specialty/work
Street address
Urology Department Bahonar Hospital
City
kerman
Postal code
Phone
+98 34 1211 4348
Fax
+98 34 1223 9188
Email
dr.ketabchi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Dr.Ali Asghar ketabchi
Position
Urology Associate professor
Other areas of specialty/work
Street address
Urology Department Bahonar Hospital
City
kerman
Postal code
Phone
+98 34 1211 4348
Fax
Email
dr.ketabchi@gmail.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)