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A clinical trial to compare the effectiveness of oral colchicine and placebo on the need for urethral dilation after internal urethrotomy

Protocol summary

Study aim
The effectiveness of oral colchicine and placebo on the need for urethral dilation after internal urethrotomy
Design
Totally, 176 patients with narrowing of the urethra candid for internal urethrotomy were chosen from the Ghaem Hospital, Mashhad, Iran. In this triple-blind, controlled clinical trial, the patients are assigned into parallel groups using simple and successive sampling methods.
Settings and conduct
Patients with narrowing of the urethra candid for internal urethrotomy who are candidates for internal urethrotomy at the Ghaem Hospital, Mashhad, Iran, are chosen. In this triple-blind study, sealed opaque envelopes will be used to conceal the sequencing. The participants, person responsible for data collection, and clinical care provider are blind to group allocation and the type of drugs.
Participants/Inclusion and exclusion criteria
Inclusion criteria: narrowing shorter than 1 centimeter in bulbar urethral stricture; single urethral strictures; first-time visitor; age over 20 years. Exclusion criteria: sensitivity to colchicine; having gastrointestinal problems; the history of liver failure; the history of renal disease.
Intervention groups
The intervention group will receive 1 mg oral colchicine after internal urethrotomy for 6 weeks. The control group will receive 1 mg oral placebo (Placebo will be produced the same of colchicine in terms of shape, size, taste, color, and odor by pharmaceutical company) after internal urethrotomy for 6 weeks.
Main outcome variables
Evaluation and comparison of the rate of urethral stricture, symptoms of acute urinary, and the rate of pain 6 weeks and 3 months after intervention in control and intervention groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200628047937N1
Registration date: 2020-08-12, 1399/05/22
Registration timing: prospective

Last update: 2020-08-12, 1399/05/22
Update count: 0
Registration date
2020-08-12, 1399/05/22
Registrant information
Name
Samane Shirzadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3760 4106
Email address
shirzadis921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of oral colchicine and placebo on the need for urethral dilation after internal urethrotomy
Public title
Effect of oral colchicine on urethral dilation control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Narrowing shorter than 1 centimeter in bulbar urethral stricture Single urethral strictures First-time visitor Age over 20 years
Exclusion criteria:
Sensitivity to colchicine Having gastrointestinal problems The history of liver failure The history of renal disease
Age
From 20 years old
Gender
Male
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 176
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects will be randomly assigned into two groups of 88 patients with blocks of 2 and 4 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sample selection based on a statistical analysis system (SAS), computer software. Accordingly, the participants were given codes and assigned into the intervention and control groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, person responsible for data collection, and clinical care provider are blind to group allocation and the type of drugs.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.093

Health conditions studied

1

Description of health condition studied
Urethral dilation
ICD-10 code
N36.8
ICD-10 code description
Other specified disorders of urethra

Primary outcomes

1

Description
Urethral stricture
Timepoint
6 weeks and 3 months after intervention
Method of measurement
Retrograde urethrography

2

Description
Symptoms of acute urinary
Timepoint
6 weeks and 3 months after intervention
Method of measurement
Clinical urine tests

Secondary outcomes

1

Description
The rate of pain
Timepoint
6 weeks and 3 months after intervention
Method of measurement
Analogue Scale for Pain (VAS)

Intervention groups

1

Description
Intervention group: The intervention group will receive 1 mg oral colchicine after internal urethrotomy for 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive 1 mg oral placebo (Placebo will be produced the same of colchicine in terms of shape, size, taste, color, and odor by pharmaceutical company) after internal urethrotomy for 6 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Samane Shirzadi
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3760 4106
Email
Shirzadi.samane73@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Samane Shirzadi
Position
Internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3760 4106
Email
Shirzadi.samane73@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Shirzadi
Position
Internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3760 4106
Email
Shirzadi.samane73@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Shirzadi
Position
Internship
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9187145785
Phone
+98 51 3760 4106
Email
Shirzadi.samane73@gmail.com

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
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome or the like can be shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Our data will only be available to researchers working at science centers and universities.
Under which criteria data/document could be used
Our data will be available for scholars working at science centers and universities.
From where data/document is obtainable
Samane Shirzadi provides the data analysis to the applicants via email: Shirzadi.samane73@gmail.com
What processes are involved for a request to access data/document
Applicants can respond to the email of the respondent and receive a response within a week.
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