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Protocol summary
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 before the operation and 4 weeks and 3 months after the operation, 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.
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.
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 beforeat least 2 weeks after the operationsurgery and 4 weeks and 3 months after the operationfirst 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.
مطالعه در کلینیک بیمارستان امام رضا (ع) تبریز و توسط پرسشنامه های شاخص بین المللی اختلال نعوظی (IIEF ) که قبل از عمل و 4 هفته و 3 ماه بعد از عمل توسط بیمار و یا درمانگر و پس از توضیح نحوه ی تکمیل پرسشنامه ، انجام خواهد پذیرفت.
کور سازی توسط آنالیز کننده با تطابق دارو ها و فرم های تطبیقی مذکور انجام خواهد پذیرفت.
در این مطالعه درمانگر با فرم های تطبیقی، دارو های ضروری را در اختیار بیمار قرار داده خواهد شد و درمانگر و بیمار نسبت به ماهیت دارو، کور می باشند.
مطالعه در کلینیک بیمارستان امام رضا (ع) تبریز و توسط پرسشنامه های شاخص بین المللی اختلال نعوظی (IIEF ) که حداقل ۲ هفته بعد از عمل، 4 هفته و 3 ماه بعد از ارزیابی اول توسط بیمار و یا درمانگر و پس از توضیح نحوه ی تکمیل پرسشنامه ، انجام خواهد پذیرفت.
کور سازی توسط آنالیز کننده با تطابق دارو ها و فرم های تطبیقی مذکور انجام خواهد پذیرفت.
در این مطالعه درمانگر با فرم های تطبیقی، دارو های ضروری را در اختیار بیمار قرار داده خواهد شد و درمانگر و بیمار نسبت به ماهیت دارو، کور می باشند.
مطالعه در کلینیک بیمارستان امام رضا (ع) تبریز و توسط پرسشنامه های شاخص بین المللی اختلال نعوظی (IIEF ) که قبلحداقل ۲ هفته بعد از عمل و، 4 هفته و 3 ماه بعد از عملارزیابی اول توسط بیمار و یا درمانگر و پس از توضیح نحوه ی تکمیل پرسشنامه ، انجام خواهد پذیرفت. کور سازی توسط آنالیز کننده با تطابق دارو ها و فرم های تطبیقی مذکور انجام خواهد پذیرفت. در این مطالعه درمانگر با فرم های تطبیقی، دارو های ضروری را در اختیار بیمار قرار داده خواهد شد و درمانگر و بیمار نسبت به ماهیت دارو، کور می باشند.
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 one week before surgery and the other group will receive placebo.
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.
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 onetwo week beforeafter surgery and the other group will receive placebo.
بیماران کاندید یورتروپلاستی خلفی به دو گروه همگون تقسیم خواهد شد. یک گروه تحت درمان با تادالافیل (10 میلی گرم روزانه) که حداقل از یک هفته قبل از عمل شروع شده باشد و گروه دیگر دارونما دریافت خواهند کرد
بیماران کاندید یورتروپلاستی خلفی به دو گروه همگون تقسیم خواهد شد. یک گروه تحت درمان با تادالافیل (10 میلی گرم روزانه) که حداقل از دو هفته بعد از عمل شروع شده باشد و گروه دیگر دارونما دریافت خواهند کرد
بیماران کاندید یورتروپلاستی خلفی به دو گروه همگون تقسیم خواهد شد. یک گروه تحت درمان با تادالافیل (10 میلی گرم روزانه) که حداقل از یکدو هفته قبلبعد از عمل شروع شده باشد و گروه دیگر دارونما دریافت خواهند کرد
Primary outcomes
#1
2 weeks before surgery, 4 weeks and 3 months after surgery
At least 2 weeks After surgery, 4 weeks and 3 months after first evaluation
At least 2 weeks beforeAfter surgery, 4 weeks and 3 months after surgeryfirst evaluation
2 هفته قبل از عمل، 4 هفته و 3 ماه بعد از عمل
حداقل 2 هفته بعد از عمل، 4 هفته و 3 ماه بعد از ارزیابی اول
حداقل 2 هفته قبلبعد از عمل، 4 هفته و 3 ماه بعد از عملارزیابی اول
Intervention groups
#1
Intervention group: Continuous consumption of Tadalafi 10 mg tablet, daily after surgery and at least 3 months after surgery, During before and after surgery sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
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.
Intervention group: Continuous consumption of Tadalafi 10 mg tablet, daily after surgery and at least 3 months after surgery, During before and after surgery sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
گروه مداخله: مصرف مداوم قرص تادالافیل 10 mg روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسه قبل و جلسات بعد از عمل، توضیحات در مورد نحوه تکمیل پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
گروه مداخله: مصرف مداوم قرص تادالافیل 10 mg روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسات، توضیحات در مورد نحوه تکمیل پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
گروه مداخله: مصرف مداوم قرص تادالافیل 10 mg روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسه قبل و جلسات بعد از عمل، توضیحات در مورد نحوه تکمیل پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
#2
Control group: Continuous consumption of placebo tablet, daily after surgery and at least 3 months after surgery, During before and after surgery sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
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.
Control group: Continuous consumption of placebo tablet, daily after surgery and at least 3 months after surgery, During before and after surgery sessions, we'll inform patients about filling the questionaire and discuss about possible side effects.
گروه کنترل: مصرف پلاسبو روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسه قبل و جلسات بعد از عمل، توضیحات در مورد پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
گروه کنترل: مصرف پلاسبو روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسات، توضیحات در مورد پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
گروه کنترل: مصرف پلاسبو روزانه بعد از عمل و طی حداقل 3 ماه بعد از عمل، در جلسه قبل و جلسات بعد از عمل، توضیحات در مورد پرسشنامه و دارو و عوارض احتمالی بررسی می شود.
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
Name
Hamedreza Nourian kafshgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3387 8734
Email address
hamedrezanourian@gmail.com
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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Tabriz University ofMedical sciences
Street address
Urology departement- Imam reza hospital - Golgasht st - Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
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
Secondary outcomes
empty
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
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Farzin Soleimanzadeh Ardebili
Street address
Imam Reza hospital - Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7328
Email
farzinsoleimanzade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farzin Soleimanzadeh Ardebili
Street address
Urology department - Imam reza Hospital - Golgasht st.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7328
Email
farzinsoleimanzade@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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