The aim of the study is to consider the efficacy of the Tamsulosin in facilitating the expulsion of stones and reducing the time of the expulsion of stones and needed to the analgesics in the patients suffered distal urethral calculi.Design: not blinded clinical trial. Exclusion criteria include: Multiple urethral stones; renal insufficiency; urinary tract infection; a solitary kidney; or pregnancy; history of urethral surgery; hypersensitivity to Tamsulosin; current alpha-blocker; calcium-antagonist medication; acute hydronephrosis; diabetic patients; hypertension; Obesity illnesses; use of another drugs at the same period (analgesic or anti-inflammatory ones), and complications of Tamsolusin (dizziness – tachycardia...). Entrance criteria includes: all patients with stone size of 3-10mm. Patients with the distal urethral stones distinguished by sonography or KUB or spiral computed tomography are divided into two groups: A and B. The capsule of Tamsulosin 0.4mg and the suppository of Diclofenac Sodium 50mg Q8h and a single dose of Dexamethazone 8mg (inj) are given to the patients in A group. A similar therapeutic diet is given to the patients of group B, except of Tamsulosin. Each 3 days, the questionnaire of No 2 is completes for the patients. Every patient is controlled with KUB or sonography each one or two weeks. The patients are followed up until they expel the stones, or for 4 weeks.
Main outcome measures: facilitating of expulsion of stone
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111168114N1
Registration date:2012-04-10, 1391/01/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-10, 1391/01/22
Registrant information
Name
Mostafa, Neda Avarjeh, Nabizade Moghadam
Name of organization / entity
Birjand University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56144430416
Email address
mostafa.avarjeh@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Birjand University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of tamsulosin in facilitating expulsion of distal urethral calculi.
Public title
The efficacy of tamsulosin in facilitating expulsion of stones in the patients with distal urethral calculi.
Purpose
Treatment
Inclusion/Exclusion criteria
Exclusion criteria include: Multiple urethral stones; renal insufficiency; urinary tract infection; a solitary kidney; or pregnancy; history of urethral surgery; hypersensitivity to Tamsulosin; current alpha-blocker; calcium-antagonist medication; acute hydronephrosis; diabetic patients; hypertension; Obesity illnesses; use of another drugs at the same period (analgesic or anti-inflammatory ones), and complications of Tamsulosin (dizziness – tachycardia...).
Entrance criteria includes: all patients with stone size of 3-10mm.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Birjand university of medical science
Street address
Birjand University of Medical Sciences, Ghafari Blvd, Birjand
City
Birjand
Postal code
Approval date
2011-12-10, 1390/09/19
Ethics committee reference number
579
Health conditions studied
1
Description of health condition studied
Distal ureteral calculi
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
of repelling stone
Timepoint
Once every three days, for 4 weeks
Method of measurement
The statements sick
Secondary outcomes
1
Description
The rate of consumption suppository diclofenac
Timepoint
once every three days, for 4 weeks
Method of measurement
The statements sick
2
Description
The days of repelling stone
Timepoint
once every three days, for 4 weeks
Method of measurement
According to answer the phone patients based on the removal of stone
Intervention groups
1
Description
Case Group : The capsule of Tamsulosin 0.4 mg and the suppository of Diclofenac Sodium 50 mg Q8h and a single dose of Dexamethazone 8mg (inj) are given to. Treatment will continue for 4 weeks, or till expulsion.
Category
Treatment - Drugs
2
Description
Control Group : The suppository of Diclofenac Sodium 50mg Qh and a single dose of Dexamethazone 8mg (inj) are given to. Treatment will continue for 4 weeks, or till expulsion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dear doctor's office Mr. Mohammad Njafi
Full name of responsible person
Mr. Dr. Mohammad Njafi
Street address
Taleghani street, Birjand, Southern Khorasan
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Birjand University of Medical Sciences
Full name of responsible person
Mr. Dr. Mohammad Njafi
Street address
Birjand University of Medical Sciences, Ghafari Blvd, Birjand
City
Birjand
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Birjand 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
Birjand University Of Medical Science
Full name of responsible person
Mr.Dr. Mohammad Njafi
Position
Urologist
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Blvd, Birjand
City
Birjand
Postal code
Phone
+98 56 1223 2622
Fax
Email
monadjafi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University Of Medical Science
Full name of responsible person
Mr.DR.Mohammad Najafi
Position
Urologist
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Blvd, Birjand
City
Birjand
Postal code
Phone
+98 56 1223 2622
Fax
Email
monadjafi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University Of Medical Science
Full name of responsible person
Mostafa Avarjeh
Position
Medical student
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghafari Blvd, Birjand
City
Birjand
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)