Comparison between efficacy of Tamsulosin and Terazosinin alpha-adrenergic blockers in spontaneous passage of ureter stones after Extracorporeal Shock Wave Lithotripsy
Comparison of Tamsulosin and Terazosinin alpha blockers efficacy in ureter stones passage
Design
Randomised controlled trial with a control group and 2 parallel groups, single blinded with allocated envelopes on 240 patients with distal ureter stones
Settings and conduct
Admitted patients to Sabalan hospital of Ardabil with a radiopaque distal ureter stone whom are a candidate for extracorporeal shock wave lithotripsy are enrolled in to one of the 3 groups of this study ramdomly . Colicky pain episodes, lower urinary tract symptoms, pain reliever usage, days to repel stone and complications of medical treatment will be evaluated. Also patients will be also be evaluated by ultrasound in 2 week's time.
Participants/Inclusion and exclusion criteria
1.Patients with lower ureter stone with minimal size of 5 millimetr 2.Stone is radiopaque and is detectable on CT scan 3.Patient is a candidate of Extracorporeal Shock Wave Lithotripsy
1.Patient with genitourinary tract infection 2.Patient with severe hydronephrosis 3.Diabetic patients 4.Patient with allergic histology to alpha blockers 6.Patient with ureter strictures Pregnant patients
Intervention groups
Group A or control group wich recieves only pain relievers
Group B wich recieves Tablet Terazosin 5mg daily and pain reliever if indicated
Group C wich recieves Tamsulosin 0.4 mg daily and a pain reliever if indicated
Main outcome variables
Colicky pain episodes, lower urinary tract symptoms, pain reliever usage, days to repel stone and complications of medical treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201209049659N1
Registration date:2021-01-03, 1399/10/14
Registration timing:registered_while_recruiting
Last update:2021-01-03, 1399/10/14
Update count:0
Registration date
2021-01-03, 1399/10/14
Registrant information
Name
Mohsen Khalilzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3422 4704
Email address
Mohsen73maku@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-26, 1399/10/06
Expected recruitment end date
2021-02-24, 1399/12/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy of Tamsulosin and Terazosinin alpha-adrenergic blockers in spontaneous passage of ureter stones after Extracorporeal Shock Wave Lithotripsy
Public title
Comparison of alpha blockers efficacy in kidney stones passage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with lower ureter stone with minimal size of 5 millimetr
Stone is radiopaque and is detectable on CT scan
Patient is a candidate of Extracorporeal Shock Wave Lithotripsy
Exclusion criteria:
Patient with genitourinary tract infection
Patient with severe hydronephrosis
Diabetic patients
Patient with allergic histology to alpha blockers
Patient with ureter strictures
Pregnant patients
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Randomisation sequence will be processed by Microsoft Excel program via (RANDBETWEEN) command
Blinding (investigator's opinion)
Single blinded
Blinding description
Tamsulosin and Terazosin tablets are indistinguishable for patients and can not be recognised by their appearance
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Tabriz Branch
Street address
No. 27 , Ghahere Ave., Danesh Street, Ardabil City
City
Tabriz
Province
East Azarbaijan
Postal code
5157944533
Approval date
2020-12-08, 1399/09/18
Ethics committee reference number
IR.IAU.TABRIZ.REC.1399.143
Health conditions studied
1
Description of health condition studied
Ureter stones
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Days to repel stone, Colicky pain episodes, Lower urinary tract symptoms, Total pain reliever use dosage, Complications of drugs
Timepoint
Patient outcomes upon enrollment in the study and in the 2 weeks
Method of measurement
Patient history and ultrasound imaging
Secondary outcomes
empty
Intervention groups
1
Description
Group A or control: After extracorporeal shockwave lithotripsy, patients in this group will only recieve 50 mg Diclofenac suppository in case it is needed
Category
Treatment - Drugs
2
Description
ntervention group B: After extracorporeal shockwave lithotripsy, patients in this group will recieve 5 mg Terazosin tablets once daily and Diclofenac suppository in case it is needed
Category
Treatment - Drugs
3
Description
Intervention group C: After extracorporeal shockwave lithotripsy, patients in this group will recieve 0.4 mg Tamsulosin tablets once daily and Diclofenac suppository in case it is needed for pain control.