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
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N3
Registration date:2019-10-17, 1398/07/25
Registration timing:prospective
Last update:2019-10-17, 1398/07/25
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
empty
Actual recruitment end date
empty
Trial completion date
empty
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:
39
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
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
PSA Level
Timepoint
Before and one month after drug injection
Method of measurement
laboratory kit
3
Description
IPSS Score
Timepoint
Before and one month after drug injection
Method of measurement
IPSS Questionnaire
4
Description
The incidence of drug side effects
Timepoint
One month after drug injection
Method of measurement
Ask the patient
5
Description
The amount of post voiding residue(PVR)
Timepoint
One day after leaving the cathedral
Method of measurement
Ultrasound
Secondary outcomes
1
Description
IPSS Score
Timepoint
Before and one month after drug administration
Method of measurement
IPSS Questionnaire
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.