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)
Determination of the safety of omitting continuous antibiotic prophylaxis (long-term) in patients with Double-J ureteral stent following transurethral lithotripsy (TUL)
Design
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
Settings and conduct
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 ciprofloxacin (500 mg) before inserting the stent. Patients in control group 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 the stent is removed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: have a sterile urine culture before stent placement; Exclusion criteria: use of antibiotics during the 2 weeks before the stenting operation, history of prostate and bladder cancer, Recurrent urinary tract infections, obstruction history
Intervention groups
Intervention group: receiving single dose ciprofloxacin (500 mg) before inserting the stent;
Control group: receiving 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until the stent is removed
Main outcome variables
Urinary tract infection, fever and stent-related complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220213054009N1
Registration date:2022-04-18, 1401/01/29
Registration timing:prospective
Last update:2022-04-18, 1401/01/29
Update count:1
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Reza Shahrokhi Damavand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3352 5259
Email address
reza_sh_urg@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-21, 1401/02/31
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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)
Public title
Comparison of prophylactic effect of single-dose and continuous-dose antibiotics on urinary tract infections (UTI) following transurethral lithotripsy (TUL)
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Sardar Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Approval date
2022-01-26, 1400/11/06
Ethics committee reference number
IR.GUMS.REC.1400.523
Health conditions studied
1
Description of health condition studied
Post-operative urinary tract infection
ICD-10 code
T83.51
ICD-10 code description
Infection and inflammatory reaction due to urinary catheter
Primary outcomes
1
Description
Urinary tract infection after inserting the stent
Timepoint
Before removing the stent (average time to have a stent) and one week after removing the stent
Method of measurement
Urine culture and urinalysis
2
Description
Fever
Timepoint
During the stent period
Method of measurement
Interview and physical exam
Secondary outcomes
1
Description
Hematuria
Timepoint
At the time of removing the stent
Method of measurement
Questionnaire
2
Description
Dysuria
Timepoint
At the time of removing the stent
Method of measurement
Questionnaire
3
Description
Frequency
Timepoint
At the time of removing the stent
Method of measurement
Questionnaire
4
Description
Nocturia
Timepoint
At the time of removing the stent
Method of measurement
Questionnaire
5
Description
Flank pain
Timepoint
At the time of removing the stent
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: receiving single dose ciprofloxacin (500 mg) before inserting the stent
Category
Treatment - Drugs
2
Description
Control group: receiving 1 tablet of ciprofloxacin (500 mg) every 12 hours for 3 days and then one tablet of ciprofloxacin (250 mg) every night until the stent is removed
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Reza Shahrokhi Damavand
Street address
Sardar-e-Jangal street
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Email
reza_sh_urg@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Siavash Falahatkar
Street address
Sardar-e-Jangal Avenue
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
urc@gums.ac.ir
Web page address
https://urc.gums.ac.ir/
Grant name
10506
Grant code / Reference number
32
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urology Research Center, Guilan University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Bahador Heidari Bateni
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Ave.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
Bahador_hb@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Reza Shahrokhi Damavand
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Sardar-e-Jangal Ave.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
reza_sh_urg@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Urology Research Center, Guilan University of Medical Sciences
Full name of responsible person
Samaneh Esmaeili
Position
Non-faculty researcher
Latest degree
Master
Other areas of specialty/work
Urology
Street address
Sardar Jangal St.
City
Rasht
Province
Guilan
Postal code
41448-95655
Phone
+98 13 3352 5259
Fax
+98 13 3352 5259
Email
samaneh_815@yahoo.com
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