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Evaluation of the effect of tamsulosin on relief of ureteral stent discomfort in patients with urolithiasis

Protocol summary

Summary
Objective: Evaluation of the effect of tamsulosin on relief of discomfort caused by ureteral stenting in patients with urolithiasis being treated with transurethral litotripsy. Study design: clinical trial, randomized, double-blind, placebo given control group, multi-center. Study population: patients with unilateral urolithiasis visiting Sinal and Baharlou Hospitals (Tehran, Iran) indicated for treating with transurethral lithotripsy and Double-J stenting thereafter. Major inclusion criteria: age equal to 18 and more, urolithiasis indicated for transurethral litotripsy and Double J ureteral stenting thereafter. Major exclusion criteria: significant ureteral trauma, presence of previous ureteral stent, other concurrent operations, previous prostate resection, bladder tumors, urinary infections, history of chronic pain, pregnancy, age less than 18, prostate cancer, cardiovascular disease, coronary artery disease. Sample size: 70. Intervention being studied: Cap Tamsulosin 0.4 mg. Intervention time: after transurethral litotripsy and ureteral stenting thereafter. Primary outcome: relief of discomfort caused by ureteral stenting.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015042221886N2
Registration date: 2015-05-03, 1394/02/13
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-03, 1394/02/13
Registrant information
Name
Parvin Kasiri
Name of organization / entity
Tehran University of Medical Sciences, international branch
Country
Iran (Islamic Republic of)
Phone
+98 21 8889 6694
Email address
p-kasiri@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
All the drugs and placebos are provided by Exir Pharmaceutical Company
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-09-06, 1394/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of tamsulosin on relief of ureteral stent discomfort in patients with urolithiasis
Public title
Effect of tamsulosin on reducing discomfort caused by ureteral stenting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age equal to 18 and more; urolithiasis indicated for transurethral litotripsy and Double J ureteral stenting thereafter. Exclusion criteria: significant ureteral trauma; presence of previous ureteral stent; other concurrent operations; previous prostate resection; bladder tumors; urinary infections; history of chronic pain; pregnancy; age less than 18; prostate cancer; cardiovascular disease, coronary artery disease.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Poursina St., Tehran, Iran
City
Tehran
Postal code
Approval date
2015-02-24, 1393/12/05
Ethics committee reference number
139116

Health conditions studied

1

Description of health condition studied
Discomfort after ureteral stenting in patients with urolithiasis
ICD-10 code
N20
ICD-10 code description
Calculus of kidney and ureter

Primary outcomes

1

Description
Pain interference with sleep
Timepoint
day 14 of intervention
Method of measurement
questionnaire

2

Description
Pain interference with daily activity
Timepoint
day 14 of intervention
Method of measurement
questionnaire

3

Description
frequency of urination
Timepoint
day 14 of intervention
Method of measurement
questionnaire

4

Description
flank pain
Timepoint
day 14 of intervention
Method of measurement
questionnaire

5

Description
severity of pain during urination
Timepoint
day 14 of intervention
Method of measurement
questionnaire

6

Description
painkiller consumption
Timepoint
day 14 of intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control with placebo, a capsule similar to the tamsulosin capsule given to case group, contains inactive substance, administered once a day PO, for 14 days.
Category
Placebo

2

Description
Tamsulosin, 0.4 mg capsule, oral administration, once a day for 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Baharlou Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Exir Pharmaceutical Company
Full name of responsible person
Dr. Shahla Mirazizi
Street address
15, Rahmati Alley, Vlieasr St
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Exir Pharmaceutical Company
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
Tehran University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Medical Student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina St., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6636 2089
Fax
Email
f-gholipour@student.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahram Gooran
Position
Urologist, Fellowship of kidney transplantation, assistant professor
Other areas of specialty/work
Street address
Imam Khomeini St., Hasan Abad Sq., Sina Hospital
City
Tehran
Postal code
Phone
+98 21 6634 8500
Fax
Email
shahram_gooran@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farshad Gholipour
Position
Medical Student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Poursina St.
City
Tehran
Postal code
Phone
+98 21 6636 2089
Fax
Email
f-gholipour@student.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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