Comparing effect of tamsulosin drug and Lithorex B on renal colic and the expulsion of renal stone and urinary stones after extracorporeal shock wave lithotripsy (ESWL)
Background: Our aim was to compare oral tamsulosin and Lithorex B for treatment of renal colic and stone passage after extracorporeal shockwave lithotripsy (ESWL)
Methods: In this randomized clinical trial from March 2014-2016 sixty four (64) patients with renal and upper ureteral stones with size less than 20 millimeter that referred to Shahid Beheshti Hospital of Yasuj after taking informed consent form and approval of ethics committee are divided into two groups by simple sampling method. In all patients completed history and physical exam was done and basal serum samples was checked. Patients who have coagulopathy; active infection; azotemia; uncontrolled hypertension; hypersensitivity to narcotic or analgesic drugs and pregnant women were excluded. Then in both groups extracorporeal shockwave lithotripsy was done. Then patients were observed for two hours and if patient have no complication, they will be allocated in two groups. In both groups it has been offered that patients should drink 10-12 glasses of water every day. In first group one tablet of Lithorex B was prescribed by one glass of water every 8 hour. In the second group a capsule of tamsulosin was prescribed with one glass of water every night. Two weeks later patients were visited again and KUB or ultrasonography was done and efficacy of treatment according to change in the size of stone and the existence of residual stones were measured and recorded. The pain intensity of patients’ before and after ESWL and during taking drugs measured and recorded by means of visual analog scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201606151323N10
Registration date:2016-08-28, 1395/06/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-28, 1395/06/07
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research vice chancellor, Yasuj University of Medical Sciences,
Expected recruitment start date
2014-03-01, 1392/12/10
Expected recruitment end date
2016-03-01, 1394/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of tamsulosin drug and Lithorex B on renal colic and the expulsion of renal stone and urinary stones after extracorporeal shock wave lithotripsy (ESWL)
Public title
tamsulosin versus Lithorex B on renal colic and the expulsion of urinary stones after extracorporeal shock wave lithotripsy (ESWL)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 15 years old suffering from renal or upper ureteral stone; stone size less than 20 millimeter.Having informed consent form
Exclusion criteria: presence of coagulopathy; presence of active infection; presence of azotemia; uncontrolled hypertension; hypersensitivity to narcotic or analgesic drugs; pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Postal code
Approval date
2015-03-06, 1393/12/15
Ethics committee reference number
1088/2/23/پ
Health conditions studied
1
Description of health condition studied
Calculus of kidney and ureter
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Crushing of renal and upper ureteral stones less than 20milimeter
Timepoint
Two weeks after the lithotripsy and treatment
Method of measurement
KUB and Ultrasonography and report of patients
Secondary outcomes
1
Description
pain intensity before and after ESWL and during treatment
Timepoint
daily to two weeks after ESWL
Method of measurement
Visual analoge scale
Intervention groups
1
Description
In first group after Extra corporeal shockwave lithotripsy(ESWL) one tablet of Lithorex B was prescribed by one glass of water every 8 hour for two weeks.
Category
Treatment - Drugs
2
Description
In second group after Extra corporeal shockwave lithotripsy(ESWL) one capsule of tamsulosin 0.4 milligram was prescribed by one glass of water every night for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti hospital
Full name of responsible person
Sadrollah Mehrabi
Street address
Shaheed Beheshi hospital, Montazeri street, Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor , Yasuj University of Medical Sciences
Full name of responsible person
Mehdi Akbartabar
Street address
Mottahari street,Research vice chancelor, Yasuj University of Medical Sciences, , Yasuj, Iran
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor , Yasuj 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
Faculty of Medicine,Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
professor, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
sadrollahm@yahoo.com and dr.mehrabi@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of medicine,Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
professor, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street,Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
sadrollahm@yahoo.com and dr.mehrabi@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of medicine, Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor of urology department, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
sadrollahm@yahoo.com
dr.mehrabi@yums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)