This study was conducted in Tabriz Hospital and participants through simple randomization divided into intervention and control groups, and double blind study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with at least three months urination problems; age between 18 to 65 years old; signing informed consent form. Exclusion criteria: active urinary tract infection; history of neurological disorders; pregnant women.
Intervention groups
Intervention group percieve tamsulosin and control group percieve placebo
Main outcome variables
Prevention of urinary retention and urinary complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200111046086N1
Registration date:2020-03-31, 1399/01/12
Registration timing:registered_while_recruiting
Last update:2020-03-31, 1399/01/12
Update count:0
Registration date
2020-03-31, 1399/01/12
Registrant information
Name
Changiz Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
ch.naseri@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of Tamsulosin and placebo in the treatment of urinary tract disorder in women
Public title
Tamsulosin for treatment of urinary tract disorder in women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with at least three months of urinary tract disorder
Age between 18 to 65 years old
Signing informed consent form
Exclusion criteria:
Active urinary tract infection
History of neurological disorders
Pregnant women
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
252
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double-blinded study and researcher and patients are kept unaware of intervention in each group and In order to allocation concealment, the type of intervention will be written on paper and placed in numbered, matte and packed envelopes.The envelopes will be opened in the order of participation of the participants and the type of group will be determined.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street