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
-
-
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.
Ethics committees
1
-
Ethics committee
-
-
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
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.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
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
-
50
-
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
-
Undecided - It is not yet known if there will be 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
-
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