Evaluation of the Effect of Topical Corticosteroid on the Prevention of Recurrence of Urethral Stenosis after Internal Urethrotomy
Design
Intervention Group: There are Patients Who are injected with 20cc Triamcinolone Ointment into Their Ducts after Internal Surgery and a Suitable Catheter is Implanted for a Week . We Examine Them After 1 and 3 Months.
Settings and conduct
Sabzevar Vaseii Hospital
Participants/Inclusion and exclusion criteria
log in:
Patients with Urethral Stricture Who Have Undergone Urethrotomy
Patient Satisfaction
Men Over 18 Years
Ability to Cooperate with the Patient Using Topical Corticosteroids
Exit:
Reluctance of some Patients
Inability to Cooperate with Topical Corticosteroids
Age Under 18 Years
Women with Urethral Stenosis
History of Previous Open Duct Surgery
Intervention groups
Control Group: There are the Patients for Who an Appropriate Number of Catheters is Implanted after Internal Ejaculation Surgery. At the End of One Week, The Catheter is Removed and after 1 and 3 Months, We Examine the Recurrence of Stenosis with Uroflowmetry.
Main outcome variables
Urethral Stenosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200308046722N1
Registration date:2021-06-08, 1400/03/18
Registration timing:registered_while_recruiting
Last update:2021-06-08, 1400/03/18
Update count:0
Registration date
2021-06-08, 1400/03/18
Registrant information
Name
melika jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3220 2986
Email address
jalali613@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-09-06, 1400/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Topical Steroids on the Prevention of Recurrence of Stenosis after Internal Urethrotomy
Public title
Evaluation of the Effect of Topical Steroids on the Prevention of Recurrence of Stenosis after Internal Urethrotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Patient with Urethral Stenosis Who Have Undergone Internal Urethrotomy Surgery
Patient Satisfaction
The Patient Have Ability to Cooperate for Using Topical Corticosteroid
Age Over 18 Years
Exclusion criteria:
Patient Reluctance
Patient Who Can't Be Cooperative
Age Under 18 Years
Women with Urethral Stenosis
History of Previous Open Urethral Surgery
Age
From 18 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
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 Sabzevar University of Medical Sciences
Street address
Pardis,Shohadaye Hasteii Blvd,Tohid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2020-02-15, 1398/11/26
Ethics committee reference number
IR.MEDSAB.REC.1398.100
Health conditions studied
1
Description of health condition studied
Urethral Stenosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Urethral Stricture
Timepoint
3 Months
Method of measurement
Uroflowmetry
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: There are the Patients for Who an Appropriate Number of Catheters is Implanted after Internal Ejaculation Surgery. At the End of One Week, The Catheter is Removed and after 1 and 3 Months, We Examine the Recurrence of Stenosis with Uroflowmetry.
Category
Treatment - Devices
2
Description
Intervention Group: There are Patients Who are injected with 20cc Triamcinolone Ointment into Their Ducts after Internal Surgery and a Suitable Catheter is Implanted for a Week . We Examine Them After 1 and 3 Months with Uroflowmetry.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vaseii Hospital
Full name of responsible person
Dr Hamidreza Baghani Avval
Street address
Pardis, Shohadaye hasteii Blvd., Tohid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617747431
Phone
+98 51 4465 1300
Email
jalali613@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology
Street address
Pardis, Shohadaye hasteii Blvd., Tohid Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8101
Email
jalali613@yahoo.com
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
Dr Hamidreza Baghani Avval
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
13th Alley, Kashefi st.
City
Sabzevar
Province
Razavi Khorasan
Postal code
96179131114
Phone
+98 51 4401 8101
Email
hamidreza_baghani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Hamidreza Baghani Avval
Position
Proffessor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
13th Alley, Kashefi St.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8101
Email
hamidreza_baghani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Melika Jalali
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
83th Alley, Zibashahr St.
City
Gorgan
Province
Golestan
Postal code
4518745634
Phone
+98 17 3220 2986
Email
jalali613@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