The effectiveness of Different Tamsulosin Doses on Lower Urinary Tract Symptoms in Patients with Benign Prostatic Hyperplasia
Design
A single-blind clinical trial with two interventional groups that using a 0.4 mg tamosulosin capsule in first group and a 0.8 mg tamosulosin capsule in second groups.This clinical trial randomized whit random-numbered table.
Settings and conduct
Of the patients will come with lower urinary tract symptoms to the Imam Hasan Hospital and have inclusion criteria sampling will be done.
Patients will be placed randomly in two groups.
Patients in the first group will be recieved a 0.4 mg tamosulosin capsule and the pationts in the second group will be recieved a 0.8 mg tamosulosin capsule.
Patients will be evaluated before and after the drug consumption based on IPSS. Second evaluation will be done after 8 weeks of using the drug. Finally, data collection and analysis will be done and thus we will examine the efficacy of different Tamsolusin doses.
Participants/Inclusion and exclusion criteria
Having consent for entry to study
IPSS over 20
No history of prostate surgery
No history of Tamsulosin consumption
No significant kidney disease
Intervention groups
1. A group that will be recieved a 0.4 mg tamosulosin capsule.
2. A group that will be recieved a 0.4 mg tamosulosin capsule.
Main outcome variables
International Prostate Symptom Score(IPSS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160514027893N3
Registration date:2019-04-12, 1398/01/23
Registration timing:registered_while_recruiting
Last update:2019-04-12, 1398/01/23
Update count:0
Registration date
2019-04-12, 1398/01/23
Registrant information
Name
Ramin Haghighi
Name of organization / entity
North Khorasan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3272 4475
Email address
haghighi.ramin@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the Effectiveness of Different Tamsulosin Doses on Lower Urinary Tract Symptoms in Patients with Benign Prostatic Hyperplasia
Public title
Effect of Tamsulosin on Prostate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with LUTS (Lower Urinary Tract Symptoms) who need tamsulosin drug and are satisfied.
Exclusion criteria:
having prostat surgery history
tamsulosin consumption history
unsatisfication
Age
No age limit
Gender
Male
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups of intervention 1and 2 by random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
After selecting and randomizing, patients will be divided into two groups.
Patients will not know how to group in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
Medical School.Shahriar Ave
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.nkums.rec.1397.076
Health conditions studied
1
Description of health condition studied
Benign prostatic hyperplasia
ICD-10 code
N40
ICD-10 code description
Hyperplasia of prostate
Primary outcomes
1
Description
Reducing the amount of international prostate symptom score (IPSS)
Timepoint
Measuring IPSS at the beginning of the study (before the intervention) And 8 weeks after the start of taking tamsulosin capsules
Method of measurement
International prostate symptom score (IPSS)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: .A group that will be received a 0.4 mg tamsulosin capsule of Behestan Pharmaceutical Company once a day for 8 weeks.
Category
Treatment - Drugs
2
Description
Second intervention group: A group that will be received a 0.8 mg tamsulosin capsule of Behesatn Pharmaceutical Company once a day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hasan Hospital
Full name of responsible person
Ramin Haghighi
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
info@nkums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Amirhosein Khoshi
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3229 7096
Email
ah.khoshi@nkums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Ahmad Kameli
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Shahriar Ave, School of Nursing and Midwifery
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
ahmad_kamely@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Ramin Haghighi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3222 1910
Email
haghighi.ramin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Hossein Bavandy
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Esfarayen Road, 4 km of Arkan, Imam Hasan Hospital
City
Bojnord
Province
North Khorasan
Postal code
9453155174
Phone
+98 58 3228 9294
Email
hossein.bavandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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