Comparison of adjuvant tadalafil and tamsulosin with tamsulosin alone in patients undergoing extracorporeal shockwave lithotripsy of renal stones
Design
Clinical trial with 2 groups, with factorial groups (including intervention group 1: daily recipient of 5 mg tadalafil and 0.4 mg tamsulosin for two weeks, intervention group 2: every night 0.4 mg tamsulosin placebo tadalafil), double blind, randomized done, phase 2 on 160 patients. Using the www.randomization.org website and the permuted blocks method.
Settings and conduct
Location: Urology clinics of Kerman University of Medical Sciences, how to perform patients after extracorporeal stone crushing for two weeks are placed in the tadalafil and tamsulosin or tamsulosin placebo tadalafil group, only the pharmacist will know how to allocate the drugs and The doctor and the patient will be blind, so it is blind on both sides.
Participants/Inclusion and exclusion criteria
Entry requirements: patients over 18 years old
Having stones with a size between 5 and 20 mm in the kidney and proximal ureter
Conditions of non-entry: subject to coagulation disorders
pregnancy
Creatinine clearance below 50 ml/min
Liver dysfunction
Urgent surgery is needed to remove stone blockage
Presence of positive urine culture
Patients with simultaneous unilateral or bilateral ureteral stones
The distance between the stone and the skin is more than 12 cm
History of previous unsuccessful extracorporeal lithotripsy
Nitroglycerin
Lack of consent to participate in the study
Systolic blood pressure below 90 mm Hg at the time of treatment initiation
cataract
hypersensitivity after taking tamsulosin or tadalafil
back ache
Severe digestive disorders
priapism
Intervention groups
Intervention group 1: daily recipient of 5 mg tadalafil and 0.4 mg tamsulosin for
two weeks
Intervention group 2: 0.4 mg tamsulosin placebo tadalafil every night
Main outcome variables
stone-free status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240515061806N1
Registration date:2024-08-07, 1403/05/17
Registration timing:prospective
Last update:2024-08-07, 1403/05/17
Update count:0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Mohammadamin Hesamarefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 4232
Email address
m.hesamarefi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of adjuvant tadalafil and tamsulosin with tamsulosin alone in patients undergoing extracorporeal shockwave lithotripsy of renal stones
Public title
Comparison of the effect of the combination of two ureteral muscle relaxants and single drugs in candidate patients with renal stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years
Having stones with a size between 5 and 20 mm in the kidney and proximal ureter
Exclusion criteria:
Having coagulation disorders
pregnancy
Creatinine clearance below 50 ml/min
Liver dysfunction
Urgent surgery is needed to remove stone blockage
Presence of positive urine culture
Patients with simultaneous unilateral or bilateral ureteral stones
The distance between the stone and the skin is more than 12 cm
History of previous unsuccessful extracorporeal lithotripsy
Use of nitroglycerin and netirocanthine
Lack of consent to participate in the study
Systolic blood pressure below 90 mm Hg at the time of treatment initiation
History of cataract
History of hypersensitivity after taking tamsulosin or tadalafil
History of back ache
History of Severe digestive disorders after treatment
History of priapism
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
After performing extracorporeal stone crushing and following the usual recommendations, patients are divided into two groups. The www.randomization.org website and the permuted blocks method are used to group patients. The sequence of participants is written on papers and the papers are placed in a dark envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
The drugs will be placed in containers named A and B, and only the pharmacist of the Faculty of Pharmacy, who is responsible for making the placebo, will know the contents of the packages. In this way, patients and doctors will not know the contents of the packages.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Afzalipour Hospital - Kerman University of Medical sciences
Street address
Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616913911
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.KMU.AH.REC.1403.051
Health conditions studied
1
Description of health condition studied
renal stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
stone-free status
Timepoint
two weeks later
Method of measurement
CT Scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: receiving 5 mg of tadalafil and 0.4 mg of tamsulosin daily for two weeks.
Category
Treatment - Drugs
2
Description
0.4 mg tamsulosin placebo tadalafil nightly
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital
Full name of responsible person
Amir Reza Sadeghi Far
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
bahonarh@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Research and Technology Office, Samiya Crossroads (Tahmasababad), at the beginning of Ibn Sina Street, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
VCR@KMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammadamin Hesamarefi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Malek ashtar street
City
کرمان
Province
Kerman
Postal code
7617778583
Phone
+98 34 3251 4232
Fax
Email
m.hesamarefi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Kamalati
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Kerman, Qarani St. - Shahid Bahonar Hospital
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
Ali.kamalati@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mohammadamin Hesamarefi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Malek ashtar street
City
کرمان
Province
Kerman
Postal code
7617778583
Phone
+98 34 3251 4232
Fax
Email
m.hesamarefi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, part of the information will be published, including the comparison of the effect of tadalafil and tamsulosin with tamsulosin alone in patients with extracorporeal calcification of kidney stones.
When the data will become available and for how long
2 to 6 months after the statistical analysis of the data
To whom data/document is available
Doctors and researchers offer treatment
Under which criteria data/document could be used
In order to use the results and during the written request
From where data/document is obtainable
Ali Kamalati - Email (Ali.kamalati@yahoo.com)
What processes are involved for a request to access data/document
The purpose of accessing and using the data is to request an email to the author, a second email in case of no response as a reminder, to confirm the identity of the requester by the public respondent, to send the documentation file.