A comparative study on the effects of prevention antibiotics cefixime and levofloxacin on infections after urinary tract dilatation in patients with recurrent stenosis
A comparative study of the therapeutic effects of two antibiotics Cefixime and Levofloxacin in preventing and improving infections after urethral dilatation.
Design
Clinical trial with Control group, Parallel groups, single blind, Phase 3, 50 Patients, table of random numbers used for allocation
Settings and conduct
The present study is a double blind randomized clinical trial that was performed on 50 patients referred to the urology clinic of Ghaem Hospital due to urethral stricture from April of 2021 to the June 2022. Eligible patients were randomly divided into two groups after obtaining informed consent.
The intervention group (25 people) before and after urethral dilatation in given 500mg Levofloxacin for 3 days (one dose before urethral dilatation and two doses after urethral dilatation).The control group (25 people) before and after urethral dilatation in given 400mg cefixime for 3 days (one dose before urethral dilatation and two doses after urethral dilatation).Demographic information (age, occupation, etc.), pain during the procedure and (VAS),PVR,The rate of improvement of urinary retention symptoms, side effects of drugs and U/A,U/C,Cr were collected in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria: single stricture and less than 1.5 cm in length urethral stricture; single urethral strictures are less than 2 cm; patients over 18 years old; no history of liver and kidney problems.
Exclusion criteria: history of sensitivity to the two mentioned drugs; the patient's unwillingness to continue participation in the study.
Intervention groups
The intervention group (25 people) before and after urethral dilatation in given 500mg Levofloxacin for 3 days. The control group (25 people) before and after urethral dilatation in given 400mg Cefixime for 3 days
Main outcome variables
Side effects of drugs and lab data U/A,U/C,Cr
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220711055433N2
Registration date:2022-10-27, 1401/08/05
Registration timing:retrospective
Last update:2022-10-27, 1401/08/05
Update count:0
Registration date
2022-10-27, 1401/08/05
Registrant information
Name
Amir Abbas Asadpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3843 2256
Email address
asadpouraa@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-06, 1399/10/17
Expected recruitment end date
2022-01-07, 1400/10/17
Actual recruitment start date
2021-01-06, 1399/10/17
Actual recruitment end date
2022-06-21, 1401/03/31
Trial completion date
2025-09-22, 1404/06/31
Scientific title
A comparative study on the effects of prevention antibiotics cefixime and levofloxacin on infections after urinary tract dilatation in patients with recurrent stenosis
Public title
Comparative cefixime and levofloxacin on infections after urinary tract dilatation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Single urethral stricture and stricture length less than 2 cm
Strictures shorter than 1.5 cm in the anterior urethra
Age older than 18 years old
Exclusion criteria:
Patient refusal of participation
History of allergy to levofloxacin and cefixime
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The generation of random numbers using random blocks and the envelope method is such that the envelopes will be prepared by a member of the research team and random numbers with the help of random blocks, printed and placed inside the envelope. The lid of the envelopes will be closed and its contents will not be visible from the outside. Then the person takes an envelope and enters the intervention or control group based on the contents of the envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The evaluator and the analyst unaware of the intervention and control groups.
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
Ghoreshi Building, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2019-09-03, 1398/06/12
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.573
Health conditions studied
1
Description of health condition studied
Urethral Stricture
ICD-10 code
N35.9
ICD-10 code description
Urethral stricture, unspecified
Primary outcomes
1
Description
Urinary tract infections after urethral dilatation
Timepoint
The rate of improvement in urinary tract infection in the first, second and third months after dilatation
Method of measurement
The use of Urine analysis and Urine culture
Secondary outcomes
1
Description
Side effects caused by cefixime or levofloxacin
Timepoint
72 hours after urethral dilatation
Method of measurement
Medical records
Intervention groups
1
Description
Intervention group: Before and after urethral dilatation, a 500mg tablet of levofloxacin is given for 3 days (one dose before urethral dilatation and two doses after urethral dilatation).
Category
Treatment - Drugs
2
Description
Control group: Before and after urethral dilatation, a tablet cefixime 400 mg is given for 3 days (one dose before urethral dilatation and two doses after urethral dilatation).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Amir Abbas Asadpour
Street address
Ghaem Hospital, Ahmadabad Blvd.
City
mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3840 0001
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayor Mobarhan
Street address
Ghoreshi Department, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?