The objectives of this study is the comparison between result of trans-obturator tape method and anterior vaginal colporrhaphy in treatment of stress urinary incontinency. We will assay 60 women with stress incontinence and maximum cystocele grade 2 (POP-Q) referred to Gynecology clinic of Kerman Afzalipoor Hospital.The patients randomly will be divided in two groups : anterior colporrhaphy and Transobturator Tap surgery).
Exclusion criteria: : Other Urinary system Disorders; Chronic Disease ; Use Medicines contribute to stress urinary incontinency; Alcohole or Drug users.Patient Visited 1,6,and 12 month after surgery to diagnose complications and results of treatment (Jacobs and Blavias classification: cure:no incontinence,improvment :less than once in two weeks,failure: more than once in week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204109433N1
Registration date:2012-04-18, 1391/01/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-18, 1391/01/30
Registrant information
Name
Samira Sohbati
Name of organization / entity
Kerman University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1244 5022
Email address
871129007@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University Of Medical Sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between result of trans-obturator tape method and anterior vaginal colporrhaphy in treatment of stress urinary incontinency
Public title
Comparison between trans-obturator tape method and anterior vaginal colporrhaphy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Stress Urinary Icncontinency; Cystocel with maximum garde 2( POP-Q)
Exclusion criteria: : Other Urinary system Disorders; Chronic Disease ( for example: psychiatry diseases,DM,Heart Failure,Chronic Lung Disease,Neurologic Disorders( like MS , CVA),; Use Medicins like: benzodiazepines, Anticholinergic,Prazocine, Ca Chanel Blockers; Alcohole or Drug users.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Kerman University Of Medical Sciences/ Research Deputy
Street address
Ebne Sina Street, Jahad Boulevard
City
Kerman
Postal code
7619813159
Approval date
2010-07-06, 1389/04/15
Ethics committee reference number
k/89/154
Health conditions studied
1
Description of health condition studied
stress urinary incontinence
ICD-10 code
N39.3
ICD-10 code description
Stress incontinence
Primary outcomes
1
Description
stress urinary incontinency
Timepoint
1,6,12 month
Method of measurement
quastion
Secondary outcomes
1
Description
complications: urethral erosion, bladder perforation, urethral or vaginal perforation,abccess, hematoma in opration site, new urinary disorders
Timepoint
intraopration, 1, 6 nad 12 month aftre surgery
Method of measurement
physical examination
Intervention groups
1
Description
Transe Obturator Tape
Category
Treatment - Surgery
2
Description
Anterior Colporrhaphy surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Samira Sohbati
Street address
Department Of Obstetrics And Gynecology, Afzalipoor Hospital, Kerman University Of Medical Sciences
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University Of Medical Sciences
Full name of responsible person
Dr Zohreh Salari
Street address
Department Of Obstetrics And Gynecology, Afzalipoor Hospital, Kerman University Of Medical Sciences
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Department Of Obstetrics And Gynecology, Afzalipoor Hospital, Kerman University Of Medical Sciences
Full name of responsible person
Samira Sohbati
Position
Resident Of Obsterics And Gynecology
Other areas of specialty/work
Street address
47, Between Valfajr 25 & 27, Valfajr Street, Jomhoori Boulevard