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Evaluation study between Tention – Free Vaginal Tape and Transobturator Tape in treatment stress incontinence in women

Protocol summary

Summary
This is a study that evaluate the tension-free vaginal tape (TVT) and obturator tape (TOT) procedures in terms of continence results, outcome and complications after a median follow-up of 6 months were compared The aim of this study was to evaluate the efficacy of the TOT versus the TVT in women with stress urinary incontinence (SUI) .This is a prospective randomized clinical trial study on eighty female patients suffering from SUI that were randomly allocated to two groups; TVT (n=40) and TOT (n=40) group. Preoperative and postoperative assessments included a validated Stress and Urge Incontinence Questionnaire, a 24-h pad test. The clinicopathologic parameters of the patients included age, body mass index, onset of incontinence, previous pelvic surgery, parity, delivery, type of anesthesia, operative time, hospital stay, catheter indwelling, postoperative complications and 1, 3 and 6 months follow up of ICIQ.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201112148228N4
Registration date: 2011-12-26, 1390/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Mohammad Reza Darabi Mahboub
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 80225530511
Email address
ghodsa1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Science
Expected recruitment start date
2009-09-14, 1388/06/23
Expected recruitment end date
2010-11-14, 1389/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation study between Tention – Free Vaginal Tape and Transobturator Tape in treatment stress incontinence in women
Public title
Effect of two surgery methods in treatment stress incontinence in women
Purpose
Treatment
Inclusion/Exclusion criteria
Include criteria:Women with incontinance without history of surgery for cyctocele with SUI.Exclude criteria:neurogenic bladder urgensy incontinance;Metabolic disorder;urinary infection;over activity of detresue in urodynamic test.
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
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

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Mashhad University of Medical Science
Street address
Ghoreshi building,Daneshgah Ave
City
Mashhad
Postal code
Approval date
2009-07-23, 1388/05/01
Ethics committee reference number
87608

Health conditions studied

1

Description of health condition studied
Stress Incintinence
ICD-10 code
N39.3
ICD-10 code description
Use additional code (N32.8), if desired, to identify overactive bladder or detrusor muscle hyperactivity. N39.4 Other specified urinary incontinence Overflow Reflex Urge incontinence Use additional code (N32.8), if desired, to identify overactive bladder

Primary outcomes

1

Description
Rate of incontinence in 24 hours
Timepoint
Before Intervention
Method of measurement
History of patients

Secondary outcomes

1

Description
Rate of incontinence along a 24hours
Timepoint
Months of 1 , 3 and 6 after Intervention
Method of measurement
History

Intervention groups

1

Description
Trans Obturator tape (TOT) procedure
Category
Treatment - Surgery

2

Description
Tension free vaginal tape (TVT) procedure
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad University of Medical Science
Full name of responsible person
Dr Zhila Sheikhi
Street address
Department of urology , Mashhad University of Medical Science
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Science
Full name of responsible person
Mohammad Reza Darabi Mahboub
Street address
Department of urology , Imam Reza hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Science
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
Mashhad University of Medical Science
Full name of responsible person
Mohammad Reza Darabi Mahbob
Position
Full Professor
Other areas of specialty/work
Street address
Department of urology , Imam Reza Hospital , Mashhad university of Medical Science
City
Mashhad
Postal code
Phone
+98 51 1802 2553
Fax
Email
dr.sheikhi@yahoo.com;j_darabi@@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of urology , Imam Reza Hospital , Mashhad University of Medical Science
Full name of responsible person
Mohammad Reza Darabi Mahbob
Position
Full Professor
Other areas of specialty/work
Street address
Department of urology , Mashhad University of Medical Science
City
Mashhad
Postal code
Iran
Phone
+98 51 1802 2553
Fax
Email
dr.sheikhi@yahoo.com; j_darabi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Dr Masoud Shahabian
Position
Other areas of specialty/work
Street address
City
Mashhad
Postal code
Iran
Phone
+98 51 1852 5311
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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