Protocol summary

Study aim
Determining the effectiveness of treatment with terazosin using IPSS questionnaire before and After treatment
Design
110 people were randomly selected from those who came to the Urology Clinic of Vasei Hospital and private offices with complaints of urinary obstruction symptoms and after Written informed consent was entered into the study. There is no need to blind the samples.
Settings and conduct
For 110 patients with urinary obstruction symptoms, the IPSS questionnaire was completed first before the treatment with terazosin. Then patients are subjected to uroflowmetry and determination of urinary residue. The drug terazosin is prescribed at a dose of 2 mg once a day for 1 month. Then again the IPSS questionnaire is completed by the patients and uroflowmetry is performed for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All women over 18 years of age who refer to Urology Clinic of Vaesi Hospital or private urology practice with urinary obstruction symptoms. Exclusion criteria: drug side effects such as dizziness or orthostatic hypotension
Intervention groups
For patients with urinary obstruction symptoms, the IPSS questionnaire is first completed before treatment with terazosin. Then patients are subjected to uroflowmetry and determination of urinary residue. The drug terazosin is prescribed at a dose of 2 mg once a day for 1 month. Then again the IPSS questionnaire is completed by the patients and uroflowmetry is performed for all patients. Since all participants are treated with the same drug and with the same dose, there is no need to The samples are not blinded.
Main outcome variables
The average volume of administration and after taking terazosin; Blood flow rate and after taking terazosin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221223056903N1
Registration date: 2023-04-15, 1402/01/26
Registration timing: registered_while_recruiting

Last update: 2023-04-15, 1402/01/26
Update count: 0
Registration date
2023-04-15, 1402/01/26
Registrant information
Name
azadeh shakeriasil
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 5138
Email address
shakeria94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Terazosin effect on the treatment of urinary tract obstruction symptoms in women
Public title
Terazosin effect on the treatment of urinary tract obstruction symptoms in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All women over the age of 18 years who complain of obstructive symptoms and go to the urology treatment of Vaesi Hospital or a private urology office are included in the study.
Exclusion criteria:
causing drug side effects such as dizziness or orthostatic hypotension Lack of informed consent to participate in the study
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 110
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
shohadaye gomnam Avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Approval date
2023-01-04, 1401/10/14
Ethics committee reference number
IR.MEDSAB.REC.1401.087

Health conditions studied

1

Description of health condition studied
Urinary obstruction symptoms in women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Urinary obstruction symptoms in women
Timepoint
Measuring the average urine volume with uroflowmetry and completing the International Prostate Symptom Scoring Questionnaire (IPSS) at the beginning of the study and one month after taking the drug.
Method of measurement
Uroflowmetry and International Prostate Symptom Scoring Questionnaire (IPSS) questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:A total of 110 people were randomly selected from those who referred to the Urology Clinic of Vasi Hospital and private practices with complaints of urinary obstruction symptoms and were included in the study after obtaining written informed consent. For all women referring with urinary obstruction symptoms,International scoring of symptoms prostate(IPSS) is completed first before treatment with terazosin. Then patients are subjected to uroflowmetry and determination of urinary residue. The drug terazosin is prescribed at a dose of 2 mg once a day for 1 month. Then the IPSS questionnaire is completed again by the patients, and uroflowmetry and urinary residual determination are performed for all patients.Then again the International scoring of symptoms prostate(IPSS) questionnaire by Takil patientsUroflowmetry and determination of urinary residue are performed for all patients. Since all participants are treated with the same drug and with the same dosage (i.e. terazosin 2 mg once a day for one month), there is no need toThe samples are not blinded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasai Hospital of Urology Clinic
Full name of responsible person
azade shakeriasil
Street address
shohadaye gomnam Avenue
City
sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Phone
+98 51 4401 1000
Fax
+98 51 4401 1000
Email
shakeriA94@medsab.ac.ir
Web page address
https://www.medsab.ac.ir/indexb742.html?siteid=1&fkeyid=&siteid=1&pageid=8530

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hossein Saqi
Street address
shohadaye gomnam avenue
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Phone
+98 51 4401 1000
Fax
+98 51 4401 1000
Email
info@medsab.ac.ir
Web page address
https://medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Azadeh Shakeriasil
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Janat western
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Phone
+98 51 4423 5138
Fax
Email
shakeriA94@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hamidreza baghaniaval
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Janat western
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Phone
+98 51 4423 5138
Fax
Email
shakeriA94@medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Azadeh Shakeriasil
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Janat western
City
Sabzevar
Province
Razavi Khorasan
Postal code
9619635989
Phone
+98 51 4423 5138
Fax
Email
shakeriA94@medsab.ac.ir

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
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