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Trial registered on ANZCTR


Registration number
ACTRN12618000383268
Ethics application status
Approved
Date submitted
27/01/2018
Date registered
14/03/2018
Date last updated
2/03/2021
Date data sharing statement initially provided
2/03/2021
Date results information initially provided
2/03/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Female urinary tract fistula following pelvic surgery
Scientific title
Female lower genitourinary tract fistula following pelvic surgery
Secondary ID [1] 293889 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vesicle-vaginal fistula 306416 0
Condition category
Condition code
Renal and Urogenital 305444 305444 0 0
Other renal and urogenital disorders
Surgery 305504 305504 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
Chart review of women who have been referred with lower urinary tract fistula following pelvic surgery. Information regarding antecedent surgery, investigations performed to evaluate the urinary incontinence and time to referral/diagnosis of the fistula.
The observation period is up to 3 months.
Intervention code [1] 300157 0
Not applicable
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304580 0
Time taken for diagnosis of fistula from index surgery from review of records
Timepoint [1] 304580 0
At time of first consultation in the clinic
Primary outcome [2] 304713 0
Initial surgery relating to cause of fistula e.g. hysterectomy
Timepoint [2] 304713 0
At initial consultation, this history will be taken
Primary outcome [3] 304714 0
Time from initial surgery causing fistula to complaint of urinary incontinence
Timepoint [3] 304714 0
at initial consultation, history will be taken
Secondary outcome [1] 342457 0
Number of investigations of urinary incontinence prior to diagnosis of fistula by reviewing medical records
Timepoint [1] 342457 0
At initial consultation in the clinic

Eligibility
Key inclusion criteria
Women referred with low genitourinary fistula following pelvic surgery
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women who do not consent to the study.
Women with ureteric fistula

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/07/2012
Date of last participant enrolment
Anticipated
30/04/2018
Actual
31/08/2018
Date of last data collection
Anticipated
30/04/2018
Actual
2/01/2019
Sample size
Target
45
Accrual to date
Final
56
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 298512 0
Self funded/Unfunded
Name [1] 298512 0
Prof Judith Goh
Country [1] 298512 0
Australia
Primary sponsor type
Individual
Name
Prof Judith Goh
Address
Suite 209, Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country
Australia
Secondary sponsor category [1] 297659 0
None
Name [1] 297659 0
Address [1] 297659 0
Country [1] 297659 0
Other collaborator category [1] 279918 0
Individual
Name [1] 279918 0
Hannah Krause
Address [1] 279918 0
Suite 209, Ramsay Specialist Centre
Newdegate Street
Greenslopes Private Hospital
Greenslopes QLD 4120
Country [1] 279918 0
Australia
Other collaborator category [2] 279919 0
Individual
Name [2] 279919 0
Dr Sneha Parghi
Address [2] 279919 0
The Women's Hospital
20 Flemington Rd
Parkville VIC 3052
Country [2] 279919 0
Australia
Other collaborator category [3] 281670 0
Individual
Name [3] 281670 0
Krishanthy Thayalan
Address [3] 281670 0
Department Obstetrics & Gynaecology
Redlands Hospital
QLD 4165
Country [3] 281670 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299490 0
Greenslopes Ethics and Research Committee
Ethics committee address [1] 299490 0
Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120
Ethics committee country [1] 299490 0
Australia
Date submitted for ethics approval [1] 299490 0
Approval date [1] 299490 0
07/06/2012
Ethics approval number [1] 299490 0
Protocol 12/24

Summary
Brief summary
Low urinary tract fistulas is an uncommon complication of pelvic/gynaecological surgery. It presents with urinary incontinence. As it is uncommon, some clinicians may not include this condition in the differential diagnosis of urinary incontinence following surgery. Therefore, some women with this condition may have had a number of investigations with a lag time from symptoms to diagnosis and hence, a delay in treatment of the fistula.

This study will review the women's history, antecedent procedure, time of onset of urinary incontinence after surgery, type and number of investigations for the urinary incontinence, time-lag between symptomatology to diagnosis and referral for management.

The aim is to provide clinicians with a recommendations for more accurate diagnosis to allow expeditious referral and management of the urinary incontinence due to the fistula.
Trial website
Trial related presentations / publications
Public notes
Ethics committee approval was given to review charts for women with genitourinary fistula after gynaecological surgery. This review included a retrospective and ongoing prospective review of charts.

Contacts
Principal investigator
Name 80590 0
Prof Judith Goh
Address 80590 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 80590 0
Australia
Phone 80590 0
+61 7 38479909
Fax 80590 0
+61 7 38476433
Email 80590 0
[email protected]
Contact person for public queries
Name 80591 0
Judith Goh
Address 80591 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 80591 0
Australia
Phone 80591 0
+61 7 38479909
Fax 80591 0
+61 7 38476433
Email 80591 0
[email protected]
Contact person for scientific queries
Name 80592 0
Judith Goh
Address 80592 0
Suite 209, Ramsay Specialist Centre
Greenslopes Private Hospital
Newdegate St
Greenslopes QLD 4120
Country 80592 0
Australia
Phone 80592 0
+61 7 38479909
Fax 80592 0
+61 7 38476433
Email 80592 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
patient confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes ANZJOG Volume 60, 2020 doi:10.1111/ajo.13134 374383-(Uploaded-13-06-2020-09-46-23)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.