Comparison of the effect of tamsulosin and tadalafil in response to treatment of patients with lower urinary tract symptoms due to the severity of atherosclerosis
effect of atherosclerosis on the efficacy of tamsulosin and tadalafil in male patients with urinary obstructive symptoms
Design
A clinical trial with two groups of patients: parallel, therapeutic, simple random
Settings and conduct
Based on Framingham criteria, each person referred to Sina Hospital is rated based on age, serum cholesterol level, serum level, HDL smoking, and systolic blood pressure. Patients are divided into two groups with a high risk of coronary artery disease and low to moderate risk of coronary artery disease. In each group, patients are divided into two groups. In one group treatment with tamsulosin 0.4 mg daily and in the other group treatment with tadalafil 5 mg and tamsulosin 0.4 mg daily. Patients were evaluated for PVR, IPSS, IPSS-QOL, and IIEF-5 before, 4, 8, and 12 weeks after treatment. Q max is assessed before treatment and after 12 weeks. The data will be analyzed using spss22 software. A comparison of quantitative variables in the study with the T-test and comparison of qualitative variables with the Chi-square test is performed and in cases where the distribution of data is not normal by non-parametric tests Used.
Participants/Inclusion and exclusion criteria
inclusion criteria: Male patients referred to urology clinic with obstructive and urinary tract symptoms for at least 6 months
Patients over 50 years of age
Exclusion criteria:
Cardiovascular diseases such as significant angina that need to be checked by a cardiologist and CHF not compensated, recent MI and uncontrolled blood pressure
treatment with nitrates
Intervention groups
Intervention group1: Treatment with tamsulosin 0.4 mg daily
Intervention group2: Treatment with tadalafil 5 mg +tamsulosin 0.4 mg daily
Main outcome variables
Effective treatments for obstructive and urinary tract symptoms in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191230045943N1
Registration date:2020-10-03, 1399/07/12
Registration timing:registered_while_recruiting
Last update:2020-10-03, 1399/07/12
Update count:0
Registration date
2020-10-03, 1399/07/12
Registrant information
Name
Ali Tavoosian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8561
Email address
alitavoosian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-30, 1399/07/09
Expected recruitment end date
2021-05-30, 1400/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of tamsulosin and tadalafil in response to treatment of patients with lower urinary tract symptoms due to the severity of atherosclerosis
Public title
the effect of tamsulosin and tadalafil in response to treatment of patients with lower urinary tract symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male patients referred to urology clinic with obstructive and urinary tract symptoms for at least 6 months
Patients over 50 years of age
Exclusion criteria:
Male patients referred to urology clinic less than 50 years old
PSA higher than 10
Urine residue 300ml or higher determined by ultrasound
Receiving Finasteride during the last 3 months
Receiving anti-androgen drugs
History of pelvic surgery or radiotherapy
History of lower urinary tract malignancy
Lower urinary tract trauma
Urinary retention
Bladder stones
Urinary tract infection that is determined by urine culture
Urethral stricture
Neurological disease affecting bladder function
Secondary obstruction to the median lobe of the prostate
Prostate cancer
Liver or kidney failure
Cardiovascular diseases such as significant angina that need to be checked by a cardiologist and CHF not compensated, recent MI and uncontrolled blood pressure
treatment with nitrates
Uncontrolled diabetes HbAlc> 9%
Age
From 50 years old to 100 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method used will be simple randomization. And the random number table will be used. If a number is randomly selected we will move to the right according to the present contract and if the number even comes in The patient will be admitted to the intervention group and if the number comes in, the patient will be included in the second group. (Assigning patients based on the severity of atherosclerosis in two general categories of low severity and high severity of atherosclerosis based on the couple and individual referral number)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-09-30, 1399/07/09
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.042
Health conditions studied
1
Description of health condition studied
Atherosclerosis
ICD-10 code
I70
ICD-10 code description
Atherosclerosis
2
Description of health condition studied
Obstructive and urinary tract symptoms
ICD-10 code
N13.9
ICD-10 code description
Obstructive and reflux uropathy, unspecified
Primary outcomes
1
Description
Treatment of obstructive and urinary tract symptoms
Timepoint
At one month intervals for three months
Method of measurement
Q max evaluation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment with tamsulosin 0.4 mg daily one alone- (Trade names, Flomax, others )- Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks.
Category
Treatment - Drugs
2
Description
Intervention group: Treatment with tadalafil 5 mg+tamsulosin 0.4 mg once daily - Patients before treatment, 4, 8 and 12 weeks after starting treatment (PVR, IPSS, IPSS-QOL and IIEF-5) are evaluated. Q max is assessed before starting treatment and after 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Dr Ali Tavoosian
Street address
Hassan Abad street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
alitavoosian@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran. Keshavarz Boulevard, Quds Ave., Central University, Sixth Floor
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Tavoosian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
alitavoosian@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
register
Under which criteria data/document could be used
Re-information for the purpose of clarification
From where data/document is obtainable
Dr. Ali Tavoosian
What processes are involved for a request to access data/document
After the examination, the applicant will be provided with the advice of an epidemiologist and with the confidentiality of patient information.