After colporhaphy , folley catheterization is done for the patients with sutures on vaginal mucosa for prevention of urinary retention. Folley can cause urinary tract infection and pain. This study is a randomized controlled trial.Inclusion criteria:BMI:19-24, grade 1 and 2 of vaginal prolapse, Normal urine culture and analysis, agree to participate in the study. Exclusion criteria: diabetic patients. Eighty eight patients that refer to gynecology clinics of Bushehr University of Medical Sciences during 2015, randomly divide in two groups. In control group folley inserted for 72 hours and in intervention group for 24 hours after operation.urinary tract infection will be checked with urine culture and urine analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506134339N11
Registration date:2015-07-26, 1394/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-26, 1394/05/04
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice Chanceller of reseach ,Bushehr University of Medical sciense
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of 1 versus 3 days post operative urinary catheterization after anterior colporrhaphy on urinary complications
Public title
comparison of the effect of 1 versus 3 days urinary catheterization after gynecological operation on urinary complications
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria:vaginal prolapse grade 1 and 2; U/A & U/C normal; BMI 19 -24; intention to participation.
exclusion criteria:diabetic patient.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
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
Bushehr University of Medical Sciences
Street address
Bahmani campus, Bushehr University of Medical Sciences, Sabzabad Blvd, Bhmani.
City
Bushehr
Postal code
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
B-93-16-21
Health conditions studied
1
Description of health condition studied
Urinary tract infection
ICD-10 code
N30-N39
ICD-10 code description
urinary infection complicating colporhaphy
Primary outcomes
1
Description
urinary infection
Timepoint
24 and 72 hours after operation
Method of measurement
Urine analysis and culture
Secondary outcomes
1
Description
number of urinary catheterization
Timepoint
24 and 72 hours after operetion
Method of measurement
hospital records
2
Description
urinary retention
Timepoint
24 and 72 hours after operetion
Method of measurement
checking for residual urine
3
Description
duration of addmision
Timepoint
24 and 72 hours after operetion
Method of measurement
hospital record
4
Description
satisfaction of the patient
Timepoint
24 and 72 hours after operetion
Method of measurement
quastionare
Intervention groups
1
Description
intervention group: removal of urinary catheter 24 hours after operation
Category
Treatment - Devices
2
Description
control group: removal of urinary catheter 72 hours after operation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynecology clinics of Bushehr University of Medical Sciences
Full name of responsible person
Dr Elham Rahmani
Street address
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice Chanceller of reseach ,Bushehr University of Medical sciense
Full name of responsible person
Dr Afshin Ostovar
Street address
Bahmani campus, Bushehr University of Medical Sciences, Sabzabad Blvd, Bhmani.
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice Chanceller of reseach ,Bushehr University of Medical sciense
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
Bushehr University of Medical Sciences
Full name of responsible person
Dr Elham Rahmani
Position
associate professor of OB -GYN
Other areas of specialty/work
Street address
Bahmani campus, Bushehr University of Medical Sciences, Sabzabad Blvd, Bahmani.
City
Bushehr
Postal code
Phone
00
Fax
Email
rahmani@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr university of Medical Sciences
Full name of responsible person
Dr Elham Rahmani
Position
associate professor of OB -GYN
Other areas of specialty/work
Street address
Bahmani campus, Bushehr University of Medical Sciences, Sabzabad Blvd, Bhmani.
City
Bushehr
Postal code
Phone
00
Fax
Email
rahmani@bpums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)