Protocol summary
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Study aim
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Determining the effect of injectable dexamethasone administration on the frequency and excretion time of distal ureteral stones
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Design
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A randomized, double-blinding clinical trial, with the parallel groups, Phase 3 on 100 patients
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Settings and conduct
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In this randomized double-blind clinical trial study, 100 eligible patients referred to Al-Zahra Hospital in Isfahan will be included in the study and randomly divided into two groups. Patients in the first group will be prescribed dexamethasone and in the control group distilled water. Then the frequency and time of stone excretion will be compared between the two groups.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include definitive diagnosis of distal ureteral stone less than 1 cm, age over 18 years, drug indication, and consent to participate in the study.
Exclusion criteria include benign prostatic hyperplasia (BPH), concomitant stenosis, contraindications to corticosteroids, and hydronephrosis.
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Intervention groups
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Intervention group 1: Patients in this group are treated orally with tamsulosin 0.4 mg/day for two weeks. In addition, an intramuscular injection of 8 mg dexamethasone will be given.
Control group: Patients in this group receive oral tamsulosin 0.4 mg/day for two weeks. In addition, 8 mg of distilled water will be injected intramuscularly within a week.
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Main outcome variables
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Frequent distal ureteral stone excretion, Time to excrete distal ureteral stones
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200825048515N59
Registration date:
2022-09-12, 1401/06/21
Registration timing:
prospective
Last update:
2022-09-12, 1401/06/21
Update count:
1
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Registration date
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2022-09-12, 1401/06/21
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-21, 1401/06/30
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Expected recruitment end date
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2023-03-21, 1402/01/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of the effect of injectable dexamethasone on the frequency and excretion time of distal ureteral stones
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Public title
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Evaluation of the effect of injectable dexamethasone on excretion of distal ureteral stones
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Definitive diagnosis of distal ureteral stones below 1 cm
Age over 18 years
Indicated for drug therapy
Satisfaction to participate in the study
Exclusion criteria:
Having benign prostatic hyperplasia (BPH) at the same time
Having a narrowing of the urethra
Contraindications to the use of corticosteroids
Existence of hydronephrosis
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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En In this study, 100 eligible patients are randomly selected. For this, the letter A is written on 50 sheets, the letter B is written on 50 sheets, and each is placed in an envelope. Each patient is then asked to choose one of the envelopes. The patient is assigned to one of two groups depending on the selected envelope.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, two drugs, dexamethasone, and distilled water, are pre-prepared in similar syringes of the same volume and placed in coded packages, and delivered daily to the researcher. The researcher prescribes each drug without knowing the type. Also, the person recording the patient and clinical information and the statistical analyst will not be aware of the type of intervention.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-04-10, 1400/01/21
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Ethics committee reference number
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IR.MUI.MED.REC.1400.015
Health conditions studied
1
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Description of health condition studied
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Calculus of ureter
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ICD-10 code
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N20.1
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ICD-10 code description
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Calculus of ureter
Primary outcomes
1
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Description
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Frequent distal ureteral stone excretion
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Timepoint
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Until the end of two weeks of intervention
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Method of measurement
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Observational
2
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Description
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Time to excrete distal ureteral stone
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Timepoint
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Until the end of two weeks of intervention
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Method of measurement
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Observational
Intervention groups
1
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Description
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Intervention group: Patients in this group are treated orally with Tamsulosin 0.4 mg / day for two weeks. In addition, an intramuscular injection of 8 mg dexamethasone will be given.
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Category
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Treatment - Drugs
2
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Description
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Control group: Patients in this group receive oral tamsulosin 0.4 mg / day for two weeks. In addition, 8 mg of distilled water will be injected intramuscularly within a week.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Isfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available