Protocol summary
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Study aim
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Determination of the safety of omitting continuous antibiotic treatment in patients with Double-J ureteral stent following transurethral lithotripsy (TUL) and stenting
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Design
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Randomized clinical trial, with control group, parallel groups, phase 2-3 study on 90 patients, block randomization with blocks of size 4 with a ratio of 1 to 1 via a online program named sealed envelop/randomisation
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Settings and conduct
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The study will be performed in the urology ward and operating room of Razi Hospital in Rasht. This study is randomly performed on 90 patients in parallel groups. Patients in intervention group will receive single dose intravenous ciprofloxacin (400 mg) before starting the procedure. Patients in control group, in addition to antibiotics prophylaxis, will receive 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until stent removal.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: have a sterile urine culture before stent placement; Exclusion criteria: use of antibiotics during the 2 weeks before the stent insertion, history of prostate and bladder cancer, Recurrent urinary tract infections, pregnancy
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Intervention groups
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Intervention group: receiving single dose intravenous ciprofloxacin (400 mg) before procedure;
Control group: receiving single dose intravenous ciprofloxacin (400 mg) before procedure + receiving one tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until stent removal
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Main outcome variables
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Urinary tract infection, fever and stent-related symptoms
General information
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Reason for update
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More clear explanation of the type of intervention and correction of the type of consequences as well as some typographical errors
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220213054009N1
Registration date:
2022-04-18, 1401/01/29
Registration timing:
prospective
Last update:
2023-02-13, 1401/11/24
Update count:
1
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Registration date
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2022-04-18, 1401/01/29
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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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2022-05-21, 1401/02/31
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Expected recruitment end date
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2023-05-21, 1402/02/31
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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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Comparison of prophylactic effect of single-dose and continuous-dose antibiotics on urinary tract infections (UTI) in patients with Double-J ureteral stent following transurethral lithotripsy (TUL)
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Public title
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Comparison of prophylactic effect of single-dose and continuous-dose antibiotics on urinary tract infections (UTI) following transurethral lithotripsy (TUL) and stenting
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Have a sterile urine culture before stent placement
Exclusion criteria:
Fever
Use of antibiotics during the 2 weeks before the stenting operation
Purulent discharge during TUL
History or treatment of obstructive symptoms
Chronic bacterial prostatitis
Chronic pelvic pain syndrome
Prostate cancer
Chronic ureteral obstruction
Obstruction due to malignancy
Iatrogenic trauma
Conditions prone to bleeding
History of bladder cancer
Recurrent urinary tract infections
Irritable bladder syndrome
History of mental or neurological disease
Taking alpha-blockers and anticholinergics, painkillers, or other medications that may interfere with the symptoms of ureteral stent
Pregnancy
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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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2-3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization will done with blocks of size 4 with a ratio of 1 to 1 (as two groups A and B) via a online program named sealed envelop/randomization. One of the researcher (resident of urology) based on a table prepared from four random blocks, assigns patients to two groups: A (single dose) and B (continuous), by random replacement method.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not 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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2022-01-26, 1400/11/06
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Ethics committee reference number
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IR.GUMS.REC.1400.523
Health conditions studied
1
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Description of health condition studied
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Post-operative urinary tract infection
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ICD-10 code
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T83.51
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ICD-10 code description
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Infection and inflammatory reaction due to urinary catheter
Primary outcomes
1
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Description
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Urinary tract infection after inserting the stent
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Timepoint
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The mean duration of stent indwelling time and before removing the stent
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Method of measurement
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Urine culture and urinalysis
2
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Description
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Fever
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Timepoint
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During the stent indwelling time
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Method of measurement
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Interview and physical exam
3
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Description
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Hematuria
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Timepoint
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During of stent indwelling time and before removing the stent
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Method of measurement
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Interview and questionnaire
4
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Description
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Dysuria
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Timepoint
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During of stent indwelling time and before removing the stent
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Method of measurement
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Interview and questionnaire
5
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Description
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Frequency
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Timepoint
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During of stent indwelling time and before removing the stent
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Method of measurement
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Interview and questionnaire
6
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Description
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Nocturia
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Timepoint
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During of stent indwelling time and before removing the stent
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Method of measurement
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Interview and questionnaire
7
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Description
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Flank pain
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Timepoint
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During of stent indwelling time and before removing the stent
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Method of measurement
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Interview and questionnaire
Secondary outcomes
1
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Description
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Side effects of contentious antibiotics
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Timepoint
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During of stent indwelling time
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Method of measurement
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Interview
Intervention groups
1
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Description
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Intervention group: receiving single dose intravenous ciprofloxacin (400 mg) before procedure
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Category
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Treatment - Drugs
2
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Description
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Control group:receiving single dose intravenous ciprofloxacin (400 mg) before procedure + receiving 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until stent removal
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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10506
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Grant code / Reference number
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32
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Urology Research Center, Guilan 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be 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