Protocol summary
-
Study aim
-
survey of continuous use of tadalafil after posterior in men's sexual function
-
Design
-
Two arm parallel RCT with treatment and placebo arms ,double-blinded, on 80 patients
-
Settings and conduct
-
The study is performed in the clinic of Imam Reza hospital in Tabriz ,by International Index of Erectile Dysfunction ( IIEF ) questionnaires that will be completed at least 2 weeks after the surgery and 4 weeks and 3 months after first evaluation, By either patient or physician and after proper guiding of how to fill the questionnaire .
Blinding is performed by the analyzer according to the mentioned drugs and matching forms.
In this study, physician will provide the drugs for patients and give it to them based on matching forms and both physician and patient, will be blinded.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria:
Men eligible for posterior urethroplasty
Exclusion criteria:
Absence of Sexual dysfunction at presentation
Physical inability for sexual intercourse
-
Intervention groups
-
The patients who are candidates for posterior urethroplasty will be divided into two homogenous groups. One group will undergo Tadalafil (10 mg per day) treatment starting at least two week after surgery and the other group will receive placebo.
-
Main outcome variables
-
The effect of continuous use of tadalafil versus placebo in patients undergoing posterior urethroplasty; The prevalence of erectile dysfunction in the patients
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20201111049350N1
Registration date:
2020-12-25, 1399/10/05
Registration timing:
registered_while_recruiting
Last update:
2021-05-15, 1400/02/25
Update count:
1
-
Registration date
-
2020-12-25, 1399/10/05
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-12-21, 1399/10/01
-
Expected recruitment end date
-
2021-07-22, 1400/04/31
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Study of the effect of continuous use of Tadalafil on men’s sexual function after posterior urethroplasty surgery – clinical trial
-
Public title
-
Effect of continuous use of Tadalafil on men’s sexual function after surgery
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Men eligible for posterior urethroplasty whom visited at Urology clinic, Imam Reza hospital, Tabriz
Exclusion criteria:
Abscence of erectile dysfunction at presentation, or anytime during study
Physical inability to perform sexual intercourse
-
Age
-
No age limit
-
Gender
-
Male
-
Phase
-
2-3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
80
-
Randomization (investigator's opinion)
-
Not randomized
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Factorial
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-12-08, 1399/09/18
-
Ethics committee reference number
-
IR.TBZMED.REC.1399.829
Health conditions studied
1
-
Description of health condition studied
-
Erectile dysfunction
-
ICD-10 code
-
N52
-
ICD-10 code description
-
Male erectile dysfunction
Primary outcomes
1
-
Description
-
Suffering of Erectile dysfunction before and after posterior Urethroplasty
-
Timepoint
-
At least 2 weeks After surgery, 4 weeks and 3 months after first evaluation
-
Method of measurement
-
The international index of erectile function questionaire
Intervention groups
1
-
Description
-
Intervention group: Continuous consumption of Tadalafi 10 mg tablet, daily after surgery and at least 3 months after surgery, During sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: Continuous consumption of placebo tablet, daily after surgery and at least 3 months after surgery, During sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Tabriz 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
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
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is 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
-
Title and more details about the data/document
-
Specific participant data sets are to be shared
-
When the data will become available and for how long
-
starting 6 months after publication)
-
To whom data/document is available
-
This is available for people working in academic institutions and people working in related businesses.
-
Under which criteria data/document could be used
-
For use in other studies ( meta-analysis)
-
From where data/document is obtainable
-
Emailing via Corresponding author
Hamedreza Nourian Kafshgari,
Urology department, Imam Reza hospital, Tabriz University of Medical Sciences
Hamedrezanourian@gmail.com
-
What processes are involved for a request to access data/document
-
After confirmation of Corresponding author and Urology departemant of Tabriz medical University, Information will be provided considering confidentiality
-
Comments
-