Comparative study of the synergistic effect of Iso Surbide Di Nitrate on standard medical treatment in acute urinary retention compared to current standard treatment alone
Evaluation of the effect of adding ISDN to the standard treatment of acute urinary retention and comparison of the synergistic effect of this drug
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 78 patients. Sealed envelopes were used for randomization.
Settings and conduct
This study contains urology emergency department of Imam Reza (AS) and Ghaem hospitals due to acute urinary retention due to BPH. This study will be performed as randomized-clinical-trial. Eligible patients are randomly divided into two groups after obtaining conscious consent:
1 - A group that in addition to the standard treatment , 10 mg of sublingual ISDN is consumed daily for up to three weeks.
2 - Control group, which alone will be given the standard treatment
Blindness will be performed for both groups of patients.
Participants/Inclusion and exclusion criteria
Entering criteria : 1) the patient has acute urinary retention 2) age more than 50 years. 3) The first episode of urinary retention 4) No other treatment or surgery indication 5) The patient's urinary retention is due to BPH
The criteria for leaving the study include: 1) a history of any heart, liver, kidney, metabolic, and seizures.2) The patient has a fever of more than 38 C, 3) a high PSA (above 4) or a suspicious examination that increases the suspicion of prostate cancer. 4) Secondary urinary retention in other cases, such as neurogenic bladder
Intervention groups
The use of isosorbide dinydrate in the treatment of acute urinary retention in patients with BPH sublingually in addition to the usual standard treatments (alpha-blocker and antiandrogen)
The control group will receive standard treatment
Main outcome variables
Increasing the effectiveness of drug therapy in the treatment of acute urinary retention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170417033489N5
Registration date:2020-05-08, 1399/02/19
Registration timing:registered_while_recruiting
Last update:2020-05-08, 1399/02/19
Update count:0
Registration date
2020-05-08, 1399/02/19
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
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the synergistic effect of Iso Surbide Di Nitrate on standard medical treatment in acute urinary retention compared to current standard treatment alone
Public title
Comparative study of the synergistic effect of Iso Surbide Di Nitrate on standard medical treatment in acute urinary retention compared to current standard treatment alone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has acute urinary retention
He is over 50 years old.
Has experienced the first episode of urinary retention
Is not undergoing another treatment or has no indication for surgery
The patient's urinary retention is due to the presence of BPH
Exclusion criteria:
History of any heart, liver, kidney, metabolic disease and seizures
Fever in the patient means T more than 38 degrees Celsius
High PSA (above 4) or suspicious examination that casts doubt on prostate cancer
Secondary urinary retention in other cases such as neurogenic bladder
Age
From 50 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using a sealed envelope whose sequence is randomly hidden from the patient and the researcher.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researcher
Participants are told that, in addition to standard treatment, additional treatment may be given at random, and that they will not know whether they will receive over-standard treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Imam Reza Hospital Research Center, Mashhad, Imam Reza Square, Imam Reza Hospital
City
Mashad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2019-08-26, 1398/06/04
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.643
Health conditions studied
1
Description of health condition studied
BENIGN PROSTATE HYPERPLASIA
ICD-10 code
N40
ICD-10 code description
Enlarged prostate
Primary outcomes
1
Description
Percentage of patients discharged from the urinary catheter
Timepoint
21 DAYS
Method of measurement
Lack of urinary retention following urinary catheter removal
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapyy, 10 mg of isosorbide dinitrate is used sublingualy daily for up to three weeks.
Category
Treatment - Drugs
2
Description
Control group: A group receiving standard alpha-blocker ( capsule Tamsulosin 0.4 mg Daily ) and antiandrogen ( tablet Finastride 5 mg Daily )therapy