Urinary tract infection is a common cause of morbidity. Urinary tract should be checked for cases with recurrent UTI. Some patients have frequent UTI without any abnormality in urinary tract. In this study we will evaluate the efficacy of the long- term low-dose antibiotic prophylaxis with Cotrimoxazol and Nalidixic-acid in the patients with recurrent UTI.
This study is a before and after clinical trial without control group over 100 patients with recurrent UTI who will refer to the Urology clinic, Ekbatan Hospital. These patients should not have abnormal urologic findings in clinical and para-clinical evaluations (Ultrasonography, VCUG and IVP). They will treat by Cotrimoxazol or Nalidixic-acid in long term-low dose antibiotic prophylaxis method according to urine culture and antibiogram. Both groups will follow with urine cultures in therapeutic and 6 months follow up period. Also we will evaluate the differences between age, gender, kind of microorganism, marital status, re-infection time and number of recurrences before treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112095641N2
Registration date:2011-12-15, 1390/09/24
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-12-15, 1390/09/24
Registrant information
Name
Seyed Habibollah Mousavi-bahar
Name of organization / entity
Hamedan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 0829
Email address
shmbahar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical Sciences
Expected recruitment start date
2012-01-01, 1390/10/11
Expected recruitment end date
2012-09-01, 1391/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effectiveness of long term low dose antibiotic
Prophylaxis in patients with recurrent UTI
Public title
Treatment of recurrent urinary tract infection
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Any patient with recurrent Urinary Tract Infection, at least 3 episode of UTI during past 12 months.
Exclusion criteria:
Abnormal finding in physical examination or in paraclinic (ultrasonography, VCUG, Isotope Scan, IVP)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Hamedan University of Medical Sciences
Street address
Shariati Cross Road
City
Hamedan
Postal code
Approval date
2011-11-17, 1390/08/26
Ethics committee reference number
2007/9/35/16/P/D
Health conditions studied
1
Description of health condition studied
Urinary Tract Infection
ICD-10 code
N39.0
ICD-10 code description
Urinary tract infection, site not specified
Primary outcomes
1
Description
No Urinary Tract Infection
Timepoint
Every month for 2 months and then every 2 months for 10 months
Method of measurement
Urine Culture
Secondary outcomes
1
Description
Recurence of Urinary Tract Infection
Timepoint
Every month for 2 months and then every 2 months for 10 months
Method of measurement
Urine Culture
Intervention groups
1
Description
After properly treating the current UTI, we will start longterm lowdose antibiotic (Coterimoxazole or Nalidixic acid) based on urine culture and antibiogram. One tablet per night for adults and weight adjusted dose for children.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Street address
Urology Ward
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Heidar Tavilani
Street address
Opposit to Mardom Park
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Associate Prof.
Other areas of specialty/work
Street address
Urology Ward, Ekbatan Hospital
City
Hamedan
Postal code
Phone
+98 81 1823 0829
Fax
Email
shmbahar@umsha.ac.ir , shmbahar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Associate Prof. in Urology
Other areas of specialty/work
Street address
Urology Ward, Ekbatan Hospital
City
Hamedan
Postal code
Phone
+98 81 1823 0829
Fax
Email
shmbahar@umsha.ac.ir , shmbahar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)