Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001097437
Ethics application status
Approved
Date submitted
20/06/2016
Date registered
12/08/2016
Date last updated
12/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
vaginal and abdominal surgery for female stress incontinence
Scientific title
abdominal burch colposuspension versus transobturator tape vaginal surgery in female genuine stress incontinence
Secondary ID [1] 289615 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress incontience 299193 0
Condition category
Condition code
Reproductive Health and Childbirth 299202 299202 0 0
Other reproductive health and childbirth disorders
Surgery 299591 299591 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 295085 0
Treatment: Surgery
Intervention code [2] 295223 0
Treatment: Devices
Comparator / control treatment
arm 2: abdominal burch colposuspension through laparotomy with suturing of the paravesical and parauretheral fascia at the bladder neck and midurethera to the cooper`s ligament bilaterally that will be performed by gynecologist with 5 years of experience .this will be done in shatby maternity university hospital,alexandria ,egypt..the approximate duration of the procedure is 45 minutes.
Control group
Active

Outcomes
Primary outcome [1] 298679 0
failure rate by recurrence of symptoms from medical records
Timepoint [1] 298679 0
baseline, one month ,6 month after surgery
Secondary outcome [1] 324945 0
complications as bleeding , hematoma with blood transfusion, bladder tear from medical records.
Timepoint [1] 324945 0
during surgery and one week after surgery
Secondary outcome [2] 325395 0
duration of surgery from medical records
Timepoint [2] 325395 0
during surgery

Eligibility
Key inclusion criteria
1.genuine stress incontinence.

2.mixed urinary incontinence
3.symptomatic patients
Minimum age
35 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
nil

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who cannot afford the intervention treatment will be allocated to arm 2 (abdominal burch colposuspension), and participants who can afford the intervention will be allocated to arm 1 (vaginal transobturator tape insertion)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
4/09/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 7974 0
Egypt
State/province [1] 7974 0
shatby alexandria univeristy hospital,alexandria,egypt

Funding & Sponsors
Funding source category [1] 293867 0
Hospital
Name [1] 293867 0
shatby maternity university hospital
Country [1] 293867 0
Egypt
Primary sponsor type
Individual
Name
Ahmed samy el-agwany
Address
portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Country
Egypt
Secondary sponsor category [1] 292813 0
None
Name [1] 292813 0
Address [1] 292813 0
Country [1] 292813 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295288 0
alexandria university
Ethics committee address [1] 295288 0
Ethics committee country [1] 295288 0
Egypt
Date submitted for ethics approval [1] 295288 0
Approval date [1] 295288 0
01/08/2015
Ethics approval number [1] 295288 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66778 0
Dr ahmed elagwany
Address 66778 0
portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Country 66778 0
Egypt
Phone 66778 0
+201228254247
Fax 66778 0
Email 66778 0
[email protected]
Contact person for public queries
Name 66779 0
ahmed elagwany
Address 66779 0
portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Country 66779 0
Egypt
Phone 66779 0
+201228254247
Fax 66779 0
Email 66779 0
[email protected]
Contact person for scientific queries
Name 66780 0
ahmed elagwany
Address 66780 0
portsaied street
shatby maternity university hospital besided bibliotheca alexandrina
alexandria ,egypt
20255
Country 66780 0
Egypt
Phone 66780 0
+201228254247
Fax 66780 0
Email 66780 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.