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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12616001097437 |
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Date of registration:
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12/08/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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vaginal and abdominal surgery for female stress incontinence
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Scientific title:
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abdominal burch colposuspension versus transobturator tape vaginal surgery in female genuine stress incontinence |
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Date of first enrolment:
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01/09/2015 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://anzctr.org.au/ACTRN12616001097437.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Egypt
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Contacts
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Name:
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Dr ahmed elagwany
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Address:
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portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Egypt |
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Telephone:
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+201228254247 |
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Email:
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ahmedsamyagwany@gmail.com |
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Affiliation:
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Name:
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Dr ahmed elagwany
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Address:
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portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Egypt |
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Telephone:
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+201228254247 |
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Email:
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ahmedsamyagwany@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.genuine stress incontinence.
2.mixed urinary incontinence
3.symptomatic patients
Exclusion criteria: nil
Age minimum:
35 Years
Age maximum:
No limit
Gender:
Females
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Health Condition(s) or Problem(s) studied
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Reproductive Health and Childbirth - Other reproductive health and childbirth disorders
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stress incontience ;
stress incontience
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Surgery - Surgical techniques
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Intervention(s)
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arm 1: vaginal transobturator tape insertion using prolene tape at the level of midurethera by gynecologist with 5 years of experience .this will be done in shatby maternity university hospital,alexandria ,egypt. by gynecolist with 5 years of experience. .the approximate duration of the procedure is 10-15 minutes
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Primary Outcome(s)
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failure rate by recurrence of symptoms from medical records [baseline, one month ,6 month after surgery]
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Secondary Outcome(s)
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duration of surgery from medical records [during surgery]
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complications as bleeding , hematoma with blood transfusion, bladder tear from medical records. [during surgery and one week after surgery ]
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Secondary ID(s)
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nil known
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Source(s) of Monetary Support
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shatby maternity university hospital
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Ethics review
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Status: Approved
Approval date:
Contact:
alexandria university
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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