Determining and comparing the effectiveness of tadalafil and tamsulosin on the control of bladder neck obstruction symptoms in patients with benign prostatic hyperplasia.
What will be done in the present Babylonian interventional study is to evaluate and compare the effectiveness of two drug classes in this category, including tadalafil and tamsulosin, in removing the blockage caused by BPH.
Design
A non-randomized clinical trial study without blinding with parallel groups on 48 patients who were divided into two groups of 24 people in such a way that in one group tadalafil with a dose of 5 mg once a day and in the second group tamsulosin with a dose of 0.4 mg daily both for A period of two months is prescribed for patients. Both categories of drugs are taken half an hour after dinner. After two months of taking the drugs, the patients should be examined for obstructive symptoms and bladder neck stricture through urodynamic analysis, cystourethroscopy and IPSS.
Settings and conduct
Tehran Islamic Azad University Hospitals
Participants/Inclusion and exclusion criteria
Suffering from BPH, suffering from complications of BPH progression in the form of bladder neck obstruction
Intervention groups
First intervention group: receiving tadalafil
The second intervention group: receiving tamsulosin
Main outcome variables
type of medicine
Age
The duration of the onset of symptoms of the disease
Bladder neck obstruction
Age of the patient
Side effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230628058608N1
Registration date:2023-09-25, 1402/07/03
Registration timing:registered_while_recruiting
Last update:2023-09-25, 1402/07/03
Update count:0
Registration date
2023-09-25, 1402/07/03
Registrant information
Name
Sara Negintaji zardak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 941 9867
Email address
negintaji.sara@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-21, 1402/03/31
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining and comparing the effectiveness of tadalafil and tamsulosin on the control of bladder neck obstruction symptoms in patients with benign prostatic hyperplasia.
Public title
Comparing the effectiveness of tadalafil and tamsulosin on the control of bladder neck obstruction symptoms in patients with benign prostatic hyperplasia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from BPH, suffering from complications of BPH progression in the form of bladder neck obstruction
Exclusion criteria:
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
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 of Islamic Azad University
Street address
Dr. Shariati Street., Shahid Khaghani Street (Zargandeh)
City
Tehran
Province
Tehran
Postal code
1918938136
Approval date
2022-12-25, 1401/10/04
Ethics committee reference number
ir.iau.tmu.rec.1401.326
Health conditions studied
1
Description of health condition studied
Suffering from BPH, suffering from complications of BPH progression in the form of bladder neck obstruction
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Determining and comparing the recovery rate of bladder neck obstruction symptoms in the group treated with tadalafil and tamsulosin based on age
The first intervention group: receiving tadalafil, tadalafil is prescribed to patients at a dose of 5 mg once a day for two months and half an hour after dinner. Tadalafil belongs to a group of drugs called phosphodiesterase type 5 (PDE5) inhibitors and is sold under the brand name Cialis in packs of 30 by Medipharm.
Category
Treatment - Drugs
2
Description
The second intervention group: receiving tamsulosin, tamsulosin at a dose of 0.4 mg once a day for a period of two months and half an hour after dinner is prescribed to the patients. Tamsulosin belongs to a group of drugs called phosphodiesterase type 5 (PDE5) inhibitors, and it is supplied with a dose of 0.4 mg in 30-packs by the Iranian pharmaceutical company Galinos.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals, Islamic Azad University of Tehran
Full name of responsible person
Dr. Ali Reza Nouri
Street address
Shariati, Zargandeh., South Attari Moghadam
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 6660
Email
iautmu@iautmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
University of Medical Sciences
Street address
Dr. Shariati Street., Shahid Khaghani Street (Zargandeh)
City
Tehran
Province
Tehran
Postal code
1918938136
Phone
+98 21 2200 6660
Fax
Email
iautmu@iautmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
sara negintaji zardak
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Urology
Street address
Dr. Shariati Street., Shahid Khaghani Street (Zargandeh)
City
Tehran
Province
Tehran
Postal code
1918938136
Phone
+98 21 2200 6660
Email
negintaji.sara@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Ali Reza Nouri
Position
University professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Dr. Shariati Street., Shahid Khaghani Street (Zargandeh)
City
Tehran
Province
Tehran
Postal code
1918938136
Phone
+98 21 2200 6660
Email
nouri_ar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Reza Noori
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Dr. Shariati Street., Shahid Khaghani Street (Zargandeh)
City
Tehran
Province
Tehran
Postal code
1918938136
Phone
+98 21 2200 6660
Email
nouri_ar@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available