Protocol summary

Summary
Urinary stones are one of the most common diseases of the urology. Its treatments are both surgical and medicinal. Tamsulosin is the most commonly used alpha-blocker, which has a proven role in increasing the rate of expulsion, as well as decreasing expulsion time. Recently, phosphodiesterase inhibitors such as tadalafil have been considered in the treatment of urinary stones. In this randomized, double blind clinical trial, 132 patients with lower ureteral stones, aged 18 to 65 years old, and having a single distal ureteral stone, smaller than 10 mm, will be included. Patients with GFR <30; single kidney; multiple ureteral stones; history of open or endoscopic surgery in the urinary tract and diabetes will be excluded. First, all patients will undergo physical examination, and laboratory and imaging (CT scans without contrast) will be requested. Patients will be randomly divided into three groups by random allocation, treated with: tamsulosin 0.4mg daily (group 1), tadalafil 10mg daily (group 2), and placebo (group 3). All patients with renal colic will receive diclofenac 100mg oral or suppository, and in the absence of improvement, 50mg intravenous pethidine will be prescribed. If there is a resistant colic, an emergency treatment intervention will be taken. A filter or cloth for urine filtering will be used by patients to diagnose stone expulsion. Patients will be monitored for every 2 weeks (up to a maximum of 4 weeks) until stone expulsion.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201709191853N14
Registration date: 2017-11-20, 1396/08/29
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Siavash Falahatkar
Name of organization / entity
Urology Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
urc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Urology Research Center, Guilan University of Medical Sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the therapeutic effect of tamsulosin, tadalafil and placebo in stone expulsion of patients with distal ureteral stones
Public title
The therapeutic effect of tamsulosin and tadalafil in stone expulsion of patients with ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients 18-65 years of age; individual dilated ureteral stone with a size smaller than 10mm lower than Common Illiac vascular by contrast-free CT scan; patients whose colic with a single dose of diclofenac (100mg oral or suppository) and, if not recovered, with a single dose of pethidine (50mg intravenous) in one day is improved. Exclusion criteria: Fever; patients with GFR <30; single kidney; multiple ureteral stones; history of endoscopic surgery or open surgery in the urinary tract; diabetes; gastric ulcer; concomitant treatment with alpha-blockers, calcium or nitrate antagonists; pregnant or lactating mothers; any allergic reaction to drugs used; patients requiring surgical or endoscopic intervention following non-pain relief during drug intervention (resistant colic); uremic symptoms; urinary retention; patients who have an urge to receive immediate medical intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Study is randomly double-blinded. Selection of each of the pharmaceutical packs (thamsulosin, tadalafil, placebo) for patients will be based on six random blocks.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Rasht, Gas Sq., West Shahid Beheshti Blvd., opposite of Sepah Bank
City
Rasht
Postal code
41938-93345
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.GUMS.REC.1396.41

Health conditions studied

1

Description of health condition studied
Ureter stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter

Primary outcomes

1

Description
Stone expulsion
Timepoint
2 and 4 weeks after intervention
Method of measurement
Stone expulsion by patient's observation, CT scan without contrast in case of not observing stone expulsion

Secondary outcomes

empty

Intervention groups

1

Description
Tamsulosin capsule with a dose of 0.4 mg made in Iran, one daily for a maximum of 4 weeks
Category
Treatment - Drugs

2

Description
Tadalafil tablets with a dose of 10 mg in capsule cover made in Iran, one daily for a maximum of 4 weeks
Category
Treatment - Drugs

3

Description
Placebo capsule made in Iran, one daily for a maximum of 4 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Ardalan Akhavan
Street address
Razi Hospital, Sardar Jangal Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Urology Research Centre, Guilan University of Medical Sciences
Full name of responsible person
Head of Urology Research Centre, Dr. Siavsh Falahatkar
Street address
Urology Research Centre, Razi Hospital, Sardar Jangal Street
City
Rasht
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Centre, Guilan 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
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Ardalan Akhavan
Position
Resident of Urology/ Co worker
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
Email
urc1384@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Dr. Siavash Falahatkar
Position
Urologist / Proffesor of Guilan University of Medical Sciences
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
Email
falahatkar_s@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Master Degree/ Researcher of Urology Research Center
Other areas of specialty/work
Street address
Urology Research Center, Razi Hospital, Sardar Jangal Street
City
Rasht
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.com
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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