Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
بررسی اثر سینرژیکLHRH آگونیست(Leuprorelin acetate 7.5mg) با کمپلکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری در مقایسه با اثرتجویز کمپبکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری
بررسی اثر سینرژیکLHRH آگونیست(Leuprorelin acetate 7.5mg) با کمپلکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری در مقایسه با اثرتجویز کمپلکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری
بررسی اثر سینرژیکLHRH آگونیست(Leuprorelin acetate 7.5mg) با کمپلکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری در مقایسه با اثرتجویز کمپبکسکمپلکس فیناستراید و تامسولوسین بر بهبود احتباس ادراری
General information
39
78
3978
No
No
empty
77
77
empty
2019-11-02, 1398/08/11
2019-11-02 00:00:00
empty
2019-12-31, 1398/10/10
2019-12-31 00:00:00
empty
2020-01-30, 1398/11/10
2020-01-30 00:00:00
empty
The number of samples entered was incorrect
The number of samples entered was incorrect
empty
تعداد نمونه وارد شده اشتباه بوده است
تعداد نمونه وارد شده اشتباه بوده است
empty
Sample size in each group was maximum predicted to be 39 people, and with predictable Decrease in the number of subjects it was 35 in each group.
Sample size in each group was maximum predicted to be 39 people, and with predictable Decrease in the number of subjects it was 35 in each group.
empty
حجم نمونه در هر گروه حداکثر 39نفر پیش بینی شده است که با ریزش 35نفر قابل پیش بینی بود
حجم نمونه در هر گروه حداکثر 39نفر پیش بینی شده است که با ریزش 35نفر قابل پیش بینی بود
Primary outcomes
#1
PSA Level
IPSS Score
PSA LevelIPSS Score
میزان PSA
میزان IPSS
میزان PSAIPSS
laboratory kit
IPSS Questionnaire
laboratory kitIPSS Questionnaire
كيت آزمايشگاهي
پرسشنامه IPSS
كيت آزمايشگاهيپرسشنامه IPSS
#2
IPSS Score
The incidence of drug side effects
IPSS ScoreThe incidence of drug side effects
میزان IPSS
میزان بروز عوارض دارویی
میزان IPSSبروز عوارض دارویی
Before and one month after drug injection
One month after drug injection
Before and oneOne month after drug injection
قبل و يكماه پس از تزريق دارو
يك ماه پس از تزريق دارو
قبل و يكماهيك ماه پس از تزريق دارو
IPSS Questionnaire
Ask the patient
IPSS QuestionnaireAsk the patient
پرسشنامه IPSS
پرسش از بيمار
پرسشنامه IPSSپرسش از بيمار
#3
The incidence of drug side effects
The amount of post voiding residue(PVR)
The incidenceamount of drug side effectspost voiding residue(PVR)
میزان بروز عوارض دارویی
ميزان باقيمانده ادرار
میزان بروز عوارض داروییميزان باقيمانده ادرار
One month after drug injection
One day after leaving the cathedral
One monthday after drug injectionleaving the cathedral
يك ماه پس از تزريق دارو
يك روز پس از خروج سوند
يك ماهروز پس از تزريق داروخروج سوند
Ask the patient
Ultrasound
Ask the patientUltrasound
پرسش از بيمار
سونوگرافي
پرسش از بيمارسونوگرافي
#4
The amount of post voiding residue(PVR)
empty
The amount of post voiding residue(PVR)
ميزان باقيمانده ادرار
empty
ميزان باقيمانده ادرار
One day after leaving the cathedral
empty
One day after leaving the cathedral
يك روز پس از خروج سوند
empty
يك روز پس از خروج سوند
Ultrasound
empty
Ultrasound
سونوگرافي
empty
سونوگرافي
Secondary outcomes
#1
IPSS Score
empty
IPSS Score
نمره IPSS
empty
نمره IPSS
Before and one month after drug administration
empty
Before and one month after drug administration
قبل و يك ماه پس از تزريق دارو
empty
قبل و يك ماه پس از تزريق دارو
IPSS Questionnaire
empty
IPSS Questionnaire
پرسشنامه IPSS
empty
پرسشنامه IPSS
Protocol summary
Study aim
Evaluation of the synergistic effect of LHRH agonist (Leuprorelin acetate 7.5mg) with finasteride and tamsulosin on urinary retention compared with the effect of finasteride and tamsulosin on urinary retention
Design
Clinical trial with control group with randomized double blind parallel groups
Settings and conduct
Imam Reza Hospital of Mashhad . Covered packages / medications will be given to the patients according to the randomized envelope. Random numbers generated by Excel software are listed as odd / even numbers (intervention / control) and placed in separate envelopes, respectively. After opening each envelope, the nurse will, as defined by the couple or individual code, inject as prescribed or simply deliver routine medication to the patient. Also, these patients have no contact with each other and have no knowledge of each other's treatment process.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) the patient has acute urinary retention 2) is over 50 years of age. 3) first episode of urinary retention 4) no other treatment or indication of surgery 5) patient urinary retention due to BPH
Exclusion criteria: a) no informed consent of the patient 2) a history of any cardiovascular and renal and metabolic diseases and seizures 3) a patient with fever mean T over 38 ° C 4) a high PSA level (above 4) suspected of having prostate cancer To strengthen.
Intervention groups
Intervention group or treatment group including group receiving routine benign prostate enlargement treatment (alpha-blocker treatment + 5 alphardectase inhibitor + LHRH agonist)
Control group Benign prostate enlargement treatment group (alpha-blocker + 5-alpha reductase inhibitor)
Main outcome variables
Release from catheterization one month after acute urinary retention
General information
Reason for update
The number of samples entered was incorrect
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N3
Registration date:2019-10-17, 1398/07/25
Registration timing:prospective
Last update:2020-02-25, 1398/12/06
Update count:1
Registration date
2019-10-17, 1398/07/25
Registrant information
Name
Salman Soltani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2553
Email address
soltanis@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-22, 1398/07/30
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
2019-11-02, 1398/08/11
Actual recruitment end date
2019-12-31, 1398/10/10
Trial completion date
2020-01-30, 1398/11/10
Scientific title
The effect of LHRH agonist on the improvement of urinary retention compared with the effect of finasteride and tamsulosin alone
Public title
The effect of LHRH agonist on urinary retention
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The first acute urinary retention
No other treatment
No indication of surgery
Patient's urinary retention is caused by BPH
Minimum age of 50 years
Exclusion criteria:
Informed patient dissatisfaction
History of any heart, liver, kidney, metabolic and seizure diseases
Patients with fever mean T more than 38 degrees Celsius
High PSA levels (above 4) which strengthen suspicion of prostate cancer
Age
From 50 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
78
Actual sample size reached:
77
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using Excel software. Random numbers are inserted in odd and even codes into the envelope, after the patient arrives at the admission criteria, and, if the patient is satisfied, the envelope is opened and will be assigned to the intervention or control group according to the patient's code. Paired and odd codes represent intervention and control groups.The codes are placed separately in the envelope so that the nurse who opens each envelope will not be aware of the allocation of the next envelope (until the next envelope is opened).
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluators and analysts will be unaware of intervention and control groups (the evaluator will only assess the extent of catheter release in the short term).
Placebo
Not used
Assignment
Parallel
Other design features
Sample size in each group was maximum predicted to be 39 people, and with predictable Decrease in the number of subjects it was 35 in each group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Qureshi building ,University Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
99191-91778
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.512
Health conditions studied
1
Description of health condition studied
Acute urinary retention in patients with BPH
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
The rate of catheter release in acute urinary retention induced by BPH
Timepoint
One month after drug injection
Method of measurement
No need for re-catheterization
2
Description
IPSS Score
Timepoint
Before and one month after drug injection
Method of measurement
IPSS Questionnaire
3
Description
The incidence of drug side effects
Timepoint
One month after drug injection
Method of measurement
Ask the patient
4
Description
The amount of post voiding residue(PVR)
Timepoint
One day after leaving the cathedral
Method of measurement
Ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral.In addition, patients in the intervention group will be given a single dose of LHRH agonist loperurelin acetate 7.5 mg at baseline.
Category
Treatment - Drugs
2
Description
Control group: All patients will receive routine BPH treatment including alpha-blocker tamsulosin 0.4 mg single daily oral and alpha reductase inhibitor finasteride 5 mg single daily oral.