The aim of this study is evaluation of efficacy of tamsulosin on lower ureteral stone expulsion .
Study design: researcher After explaining the purpose of the study and obtaining the informed consent of patients randomly divided into two treatment groups A and B are.The groups will be treated, randomized, single-blind, placebo-free, single-center, phase 3 trial
Study population: patients admitted to Imam Hussein hospital with a kidney stone
Inclusion criteria for the project: Patients between the ages of 18 and 60 years in with renal colic with 3 to 6 mm stones in distal ureteral or ureteral uvj
Exclusion criteria: UTI; Radiolucent stones on KUB; sever Hydronephrosis (grades 2 and 3 in ultrasound; Diabetes (FBS more than 125 milligrams per deciliter); history of peptic ulcer disease; Systolic blood pressure less than 100 mm Hg; Consumers calcium antagonist drugs; history of surgery on the distal ureter; single kidney ; creatinine more than 1.4 mg per deciliter in men and 1.2 in women; Intractable pain; NSAID intolerance ; side effects of tamsulosin; pregnancy
Sample size: 100 patients participated in the 50 patients in any branch
The intervention used in the study: Tamsulosin 4 mg orally
Intervention time: Prescribed time period prescribed tamsulosin morning and until the stone or in case of expulsion for up to four weeks after the start of the study will be
Primary outcomes: Stone expulsion time, Stone expulsion rate
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012626211N1
Registration date:2016-05-25, 1395/03/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-25, 1395/03/05
Registrant information
Name
Naghme Ahi
Name of organization / entity
Islamic Azad University of Shahroud
Country
Iran (Islamic Republic of)
Phone
+98 936 123 2544
Email address
n-ahi@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
adjutancy of Research and Technology, Islamic Azad University of Shahrood
Expected recruitment start date
2016-04-13, 1395/01/25
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tamsulosin on lower ureteral stone expulsion
Public title
The effect of tamsulosin on ureteral stones expulsion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for the project: Patients between the ages of 18 and 60 years in with renal colic with 3 to 6 mm stones in distal ureteral or ureteral uvj
Exclusion criteria: UTI; Radiolucent stones on KUB; sever Hydronephrosis (grades 2 and 3 in ultrasound; Diabetes (FBS more than 125 milligrams per deciliter); history of peptic ulcer disease; Systolic blood pressure less than 100 mm Hg; Consumers calcium antagonist drugs; history of surgery on the distal ureter; single kidney ; creatinine more than 1.4 mg per deciliter in men and 1.2 in women; Intractable pain; NSAID intolerance ; side effects of tamsulosin; pregnancy
Age
From 16 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Hafte-Tir Square, Shahroud University of Medical Sciences
City
Shahroud
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
930/08
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Stone expulsion rate
Timepoint
4 weeks after treatment
Method of measurement
Questionnaire
2
Description
Stone expulsion time
Timepoint
4 weeks after treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Amount of sedative
Timepoint
4 weeks after treatment
Method of measurement
Questionnaire
2
Description
Drug side effects
Timepoint
4 weeks after treatment
Method of measurement
Questionnaire
3
Description
Stone complications
Timepoint
4 weeks after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: Oral tamsulosin 4 mg
Intervention method: Prescribed tamsulosin Morning, and for prescribing it until the stone is Or in case of expulsion for up to four weeks after initiation of the study.
All patients from both groups to allow the use of 100 mg indomethacin treatment for symptomatic PRN (in case of unbearable pain) is given.
All patients from both groups emphasized that drink 2 liters of water daily.
Category
Treatment - Drugs
2
Description
Control:Non-use of tamsulosin oral 4mg
Control Method: All patients from both groups to allow the use of 100 mg indomethacin treatment for symptomatic PRN (in case of unbearable pain) is given.
All patients from both groups emphasized that drink 2 liters of water daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Hospital
Full name of responsible person
Street address
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
adjutancy of Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Dr sahebali manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
adjutancy of Research and Technology, Islamic Azad University of Shahrood
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
Islamic Azad University of Shahroud
Full name of responsible person
Naghme Ahi
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Postal code
Phone
+98 23 3239 0077
Fax
Email
N-Ahi@iau-shahrood.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Hussein Hospital- University of Medical Sciences shahroud
Full name of responsible person
Vahid Bolurian
Position
Urologist
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Postal code
Phone
+98 23 3239 0077
Fax
Email
Sadrv@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Mania Armin
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Postal code
Phone
+98 23 3239 0077
Fax
Email
mania_armin@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)