1. Home
  2. Approved trials
  3. » فارسی

Tamsulosin effect on the treatment of urinary tract obstruction symptoms in women

Protocol summary

Study aim
Determining the effect of Tamsulosin on treatment of urinary obstruction symptoms in women
Design
Clinical trial with only intervention group, without blinding, phase 2 on 110 patients, data are entered into spss20 software after collection. Quantitative variables will be presented as mean and standard deviation, and qualitative variables will be presented as frequency.
Settings and conduct
Patients with obstructive symptoms Referred to Vaesi Hospital in Sabzevar and Private Urology Practice in Sabzevar are included in the study. First, the IPSS symptoms questionnaire is completed for patients. Then patients are subjected to uroflowmetry and determination of residual disease. Then Tamsulosin drug is taken at a dose of 0.4 mg once a day before going to bed for 1 month. The data before and after the intervention are statistically analyzed and compared since all the participants were treated with the same drug and the same dosage (0.4 ml g once a day) and there is no need to blind the samples.
Participants/Inclusion and exclusion criteria
Women up to 18 YO with urinary tract obstruction symptoms that did not find a reason for the obstruction symptoms in the investigations and the obstruction symptoms did not develop acutely.
Intervention groups
Patients with obstructive symptoms are included in the study. First, the IPSS symptoms questionnaire is completed for patients. Then all patients are subjected to uroflowmetry and determination of residual disease. Then Tamsulosin drug is taken for all patients at a dose of 0.4 mg once a day before going to bed for 1 month.
Main outcome variables
IPSS questionnaire score; Uroflowmetry results, urinary residual amount

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230501058042N1
Registration date: 2023-05-10, 1402/02/20
Registration timing: registered_while_recruiting

Last update: 2023-05-10, 1402/02/20
Update count: 0
Registration date
2023-05-10, 1402/02/20
Registrant information
Name
Taranom Rabiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4467 2748
Email address
rabiet94@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-04, 1402/02/14
Expected recruitment end date
2023-06-04, 1402/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Tamsulosin effect on the treatment of urinary tract obstruction symptoms in women
Public title
Tamsulosin effect on the treatment of urinary tract obstruction symptoms in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female Over 18 years old With urinary tract obstruction symptoms
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Sabzevar Medical Sciences Campus, Shuhada Nuclear Martyrs Boulevard, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.MEDSAB.REC.1402.013

Health conditions studied

1

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

Primary outcomes

1

Description
IPSS Score
Timepoint
At the beginning of the study and 4 weeks after taking the drug
Method of measurement
IPSS questionnaire

Secondary outcomes

1

Description
The result of uroflowmetry
Timepoint
The beginning of the study and 4 weeks after the start of taking the drug
Method of measurement
Objective uroflowmetry

Intervention groups

1

Description
Intervention group: Tamsulosin drug with a dose of 0.4 mg daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vasi Hospital
Full name of responsible person
Tarnam Rabiei
Street address
Nuclear martyrs boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Phone
+98 51 4465 1306
Email
rabiet94@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amin Lotfi
Street address
Nuclear martyrs boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Phone
+98 51 4401 8001
Email
rabiet94@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
Amin Lotfi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Nuclear martyrs boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Phone
+98 51 4401 8001
Email
rabiet94@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Amin Lotfi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Nuclear martyrs boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Phone
+98 51 4401 8001
Email
rabiet94@medsab.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Taranom Rabie
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Nuclear martyrs boulevard
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617614615
Phone
+98 51 4467 2748
Email
rabiet94@medsab.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
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
Data is shared after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Accessible to all
Under which criteria data/document could be used
There are no special conditions.
From where data/document is obtainable
rabiet94@medsab.ac.ir
What processes are involved for a request to access data/document
Send your request to the above email.
Comments
Loading...