efficacy of dilatation with topical corticosteroid ointment in patients with meatal stricture
Design
Clinical trial without a control group; phase2; in 50 members group
Settings and conduct
This study will be done on boys under 15 years old with meatal stricture who refer to a urology clinic in Sabzevar. After taking history and configuring the meatal stricture; dilatation with nelaton catheter will be done to 10 french. Then weekly for one month will be continued. Hydrocortisone acetate 1% will be prescribed for BID use in the home. One month after the last dilatation; patients will be re_ evaluate for improvement of the meatal stricture with taking history and meatus calibration.
Participants/Inclusion and exclusion criteria
All boys under 15 years old with meatal stricture will be in the study.
If there is a history of meatus surgery except for circumcision; urogenital anomalies; history or recurrent UTI; renal failure secondary to meatal stricture; urinary reflux secondary to meatal stricture and age more than 15 years old they will be out of the study.
Intervention groups
In this study, we will examine the efficacy of dilatation with hydrocortisone ointment as a non_ invasive treatment while the standard treatment in patients with meatal stricture is meatotomy surgery. dilatation will be done with the nelaton catheter to 10 french then weekly till one month this will be continued. hydrocortisone acetate 1% will be prescribed for BID use at home.
Main outcome variables
Resolving the meatal stricture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210729052011N1
Registration date:2021-09-06, 1400/06/15
Registration timing:registered_while_recruiting
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Neda Zahraei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4723 3980
Email address
nedazahraei9593@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-06, 1400/06/15
Expected recruitment end date
2021-10-22, 1400/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of meatal dilatation with topical hydrocortisone ointment in the treatment of meatal stricture
Public title
efficacy of topical hydrocortisone ointment in meatal stricture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All boys under 15 years old with meatal stricture
Exclusion criteria:
History of meatus surgery except circumcision
Urogenital system anomalies
Renal failure secondary to meatal stricture
Urinary reflux secondary to meatal stricture
Recurrent UTI
Age
From 1 month old to 15 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Shohada hastei Blvd; Sabzevar Town;Sabzevar University of Medical Sciences
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
IR.MEDSAB.REC.1398.094
Health conditions studied
1
Description of health condition studied
Meatal stricture
ICD-10 code
N35.010
ICD-10 code description
Post-traumatic urethral stricture, male, meatal
2
Description of health condition studied
Meatal stricture
ICD-10 code
N35.111
ICD-10 code description
Postinfective urethral stricture, not elsewhere classified, male, meatal
3
Description of health condition studied
Meatal stricture
ICD-10 code
N99.110
ICD-10 code description
Postprocedural urethral stricture, male, meatal
Primary outcomes
1
Description
the amount of meatal stricture with clinical examination and qualitative report of it
Timepoint
measuring meatal stenosis at the beginning of the study and then 2 month after intervention
Method of measurement
measuring will be done with nelaton catheter and will be reported in a qualitative way.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after taking history and configuring meatal stricture, dilatation will be done with nelaton catheter and hydrocortisone acetate 1% which manufactured in Emad Darman Pars company to 10 French. then weekly till one-month dilatation will be continued in the same way. topical hydrocortisone acetate 1% ointment will be prescribed for use at home twice a day. one month after the last meatus dilatation, the patient's meatal stricture improvement will be examined by taking history and meatus calibration.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasee Hospital in Sabzevar
Full name of responsible person
Doctor Hamidreza Baghani Aval
Street address
Shohada Hastei Blv; Vasee Hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613988467
Phone
+98 51 4465 1300
Email
hamidreza_baghani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr Mohammadhosein Saghi
Street address
Sabzevar University of Medical science; Shohada Hastei Blv; Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617213112
Phone
+98 51 4401 8300
Email
saghi9@gmail.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
Doctor Hamidreza Baghani Aval
Position
Associate professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Sabzevar Medical University of Science; Shohada Hastei Blv; Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
961383136
Phone
+98 51 4401 1300
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
Doctor Hamidreza Baghani Aval
Position
Associate professor of Urology
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Sabzevar Medical University of Science; Shohada Hastei Blv; Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
961383136
Phone
+98 51 4401 1300
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
Neda Zahraei
Position
Medical intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 6, Besat5 Ave, Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618645151
Phone
+98 51 4723 3980
Fax
Email
nedazahraei9593@gmail.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