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Trial registered on ANZCTR


Registration number
ACTRN12617000241336
Ethics application status
Approved
Date submitted
18/12/2016
Date registered
16/02/2017
Date last updated
10/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring the mesh position after a successful urinary incontinence surgery
Scientific title
May the length of the surgical midurethra be longer than anatomical midurethra? An analysis of the mesh position with translabial ultrasonography in successful cases after transobturator tape operation.
Secondary ID [1] 290787 0
None
Universal Trial Number (UTN)
U1111-1191-0755
Trial acronym
AML
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 301418 0
Condition category
Condition code
Renal and Urogenital 301147 301147 0 0
Other renal and urogenital disorders
Surgery 301592 301592 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Between September 2011 and April 2016 a total of 82 successful transobturator tape (TOT) surgeries were performed at the Department of Urology, Medicine Faculty of Ahi Evran University. In this study, all cases with favorable results will be phone called prospectively for a translabial ultrasonographic examination to evaluate the mesh location after surgery. The ultrasonography will be performed by an experienced radiologist. The ultrasonographic examinations will be conducted at Medicine Faculty of Ahi Evran University.
After measuring the length of the urethra, the distance from the bladder neck and external urethral meatus to the edges of the mesh will be measured. The anatomic mid-urethra is accepted as the mid one-third of the urethral length. Patients with successful surgical results will be examined whether all the meshes are in the boundaries of the anatomic mid-urethra or not.

The width of the mesh, the distance from the urethral mucosa and from vaginal mucosa to the mesh will also be measured. All measurements will be made in mm. The posterior urethrovesical angle is going to be measured as the angle between the line parallel to the urethra and parallel to the bladder trigone during resting and valsalva. These angles will be measured for two times. The average of the degree of these angles after two different measurements will be calculated. The difference of the angles between resting and valsalva will be recorded.
Intervention code [1] 296700 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300559 0
The bounds of the anatomic and surgical midurethra will be compared after translabial ultrasonographic measurements.
Timepoint [1] 300559 0
At time of ultrasound examination
Secondary outcome [1] 330297 0
The posterior urethrovesical angle will be measured with translabial ultrasonography
Timepoint [1] 330297 0
At time of ultrasound examination

Eligibility
Key inclusion criteria
Patients who have had transobturatory tape operation at the Department Urology, Ahi Evran University between September 2011 and April 2016 with a successful surgical outcome will be included in this study. Patients without stress urinary incontinence, emptying problem, extrusion of the mesh or erosion of the urethra will be accepted as surgical success. Patients who had had the surgery for at least two months ago will be admitted to work.
Minimum age
26 Years
Maximum age
81 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had another urogynecological surgery simultaneously or with unsuccessful surgical outcome will be excluded from the study.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The patients with surgical success will be involved this study. Kolmogorov-Smirnov test will be used to assess the normality of distribution. Pearson’s Chi-square test will be used for the categorical variables and independent t-test will be used for continuous variables.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8520 0
Turkey
State/province [1] 8520 0
Kirsehir

Funding & Sponsors
Funding source category [1] 295213 0
Hospital
Name [1] 295213 0
Ahi Evran University Hospital
Address [1] 295213 0
Department of Radiology and Department of Urology, Ahi Evran University, Kirsehir, Turkey. Postcode:40200
Country [1] 295213 0
Turkey
Primary sponsor type
Hospital
Name
Ahi Evran University Hospital
Address
Department of Radiology and Department of Urology, Ahi Evran University, Kirsehir, Turkey Postcode:40200
Country
Turkey
Secondary sponsor category [1] 294041 0
None
Name [1] 294041 0
None
Address [1] 294041 0
None
Country [1] 294041 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296559 0
Ethics committee of medicine faculty, Ahi Evran University
Ethics committee address [1] 296559 0
Medicine Faculty of Ahi Evran University, Bagbasi Campus, Kirsehir.
Postcode:40200
Ethics committee country [1] 296559 0
Turkey
Date submitted for ethics approval [1] 296559 0
20/12/2016
Approval date [1] 296559 0
03/01/2017
Ethics approval number [1] 296559 0
2017-01/02

Summary
Brief summary
The surgical treatment of stress urinary incontinence is successfully maintained by transobturator midurethral sling (MUS) surgeries over a decade. The short and medium-term results are well understood after many clinical trials. , The mesh is being motivated to localize just under the mid part of the urethra during MUS. After understanding the “integral theory,” this concept has become more important.
The location of the mesh under the midurethra is crucial for the success and complication rates of MUS. Anatomically the midurethra is the mid one-third of the urethra. This part is the high-pressure region of the urethra. The aim of this study is to evaluate the exact location of the mesh under the urethra with translabial ultrasonography and to compare the mesh position to the anatomic midurethra in MUS patients with favorable results, and find out if there is a difference in lengths of surgical and anatomic midurethra.
Between September 2011 and April 2016 a total of 82 successful transobturator tape (TOT) surgeries were performed at the Department of Urology, Medicine Faculty of Ahi Evran University. In this study, all cases with successful results will be prospectively phone called for a translabial ultrasonographic examination to evaluate the relationship of the mesh to the surrounding structures after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71286 0
Dr Sahin Bagbanci
Address 71286 0
Department of Urology, Medicine Faculty of Ahi Evran University, Kirsehir, Turkey Postcode:40200
Country 71286 0
Turkey
Phone 71286 0
+903862134517
Fax 71286 0
Email 71286 0
sahin.bagbanci@ahievran.edu.tr
Contact person for public queries
Name 71287 0
Dr sahin bagbanci
Address 71287 0
Department of Urology, Medicine Faculty of Ahi Evran University, Kirsehir, Turkey Postcode:40200
Country 71287 0
Turkey
Phone 71287 0
+903862134517
Fax 71287 0
Email 71287 0
sahin.bagbanci@ahievran.edu.tr
Contact person for scientific queries
Name 71288 0
Dr Sahin Bagbanci
Address 71288 0
Department of Urology, Medicine Faculty of Ahi Evran University, Kirsehir, Turkey Postcode:40200
Country 71288 0
Turkey
Phone 71288 0
+903862134517
Fax 71288 0
Email 71288 0
sahin.bagbanci@ahievran.edu.tr

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary