Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12620000900910
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
11/09/2020
Date last updated
18/09/2023
Date data sharing statement initially provided
11/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Urinary sling feasibility study
Scientific title
A descriptive study to determine the feasibility of a self-fixing urinary sling procedure in adult women with urodynamic stress urinary incontinence.
Secondary ID [1] 299753 0
None
Universal Trial Number (UTN)
U1111-1243-1828
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 318259 0
Condition category
Condition code
Renal and Urogenital 316268 316268 0 0
Other renal and urogenital disorders
Surgery 316654 316654 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Performance of an autologous fascia lata pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision.
The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology.

Mode of care delivery is surgical, provided in operating theatre, with single episode provision of care lasting approximately 1 hour, with clinic follow-up 42-56 days after surgery, including assessment of voiding function, vaginal examination and completion of the Urinary Distress Inventory-Sort Form (UDI-6). The surgical intervention itself includes using an autologous fascia lata graft which is anchored using a knotless fixation method using polydioxanone sulphate. The autologous graft will remain, and the fixation device will absorb by hydrolysis in approximately 180-238 days.

Interventional adherence will be managed by having the assessment being based on intervention received.
Intervention code [1] 318084 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324506 0
Feasibility will be determined to be : Patient reported success of the procedure of greater than or equal to 70%. This assessment is conducted by directly asking the participant about this outcome.
Timepoint [1] 324506 0
42-56 Days post-surgery at scheduled follow-appointment.
Primary outcome [2] 324507 0
Percentage of participants with urinary retention requiring catheter usage for longer than 2 weeks This outcome is assessed by direct observation of participant outcome, and by assessing clinical examination and voiding function.
Timepoint [2] 324507 0
42-56 Days post-surgery at first post-operative follow-up visit.
Secondary outcome [1] 384834 0
Technical issue in sling placement, assessed by review of operation report in participant notes. Technical issues could include issues such as detachment of the sling from the anchoring device, inability to adequately position the sling, Other unanticipated issues could occur and these will be assessed in the same manner.
Timepoint [1] 384834 0
Day of surgery.
Secondary outcome [2] 384835 0
Scores of Urinary Distress Inventory, Short Form (UDI-6) that assesses a composite outcome consisting of parameters of urinary system function such as urinary frequency, leakage and voiding issues.
Timepoint [2] 384835 0
42-56 Days post-surgery at the first scheduled post-operative clinic follow-up appointment.
Secondary outcome [3] 384836 0
Post-void residual urine volume as measured by bladder scan.
Timepoint [3] 384836 0
42-56 days Post-surgery at the first scheduled post-operative clinic follow-up appointment.

Eligibility
Key inclusion criteria
Adult women with urodynamic stress urinary incontinence who would otherwise be a candidate for a mid-urethral sling procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Urinary incontinence that is not purely urodynamic stress incontinence.
Post-void residual volume of urine greater than 100 mL.
Body mass index of greater than 35.
History of prior significant pelvic or urinary tract reconstructive surgery.
Chronic vaginal or pelvic pain.
Inability to give informed consent.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Small feasibility study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics only, as no comparator group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2020
Actual
29/04/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
17/11/2022
Date of last data collection
Anticipated
19/05/2023
Actual
18/05/2023
Sample size
Target
5
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 22742 0
New Zealand
State/province [1] 22742 0
Otago

Funding & Sponsors
Funding source category [1] 304222 0
University
Name [1] 304222 0
University of Otago
Country [1] 304222 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306693 0
None
Name [1] 306693 0
Address [1] 306693 0
Country [1] 306693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304683 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 304683 0
Ethics committee country [1] 304683 0
New Zealand
Date submitted for ethics approval [1] 304683 0
04/05/2020
Approval date [1] 304683 0
13/07/2020
Ethics approval number [1] 304683 0
20/NTA/57

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

Contacts
Principal investigator
Name 97850 0
A/Prof Michael Stitely
Address 97850 0
University of Otago. Department of Women's and Children's Health PO Box 56 Dunedin 9013 NewZealand
Country 97850 0
New Zealand
Phone 97850 0
+64276678852
Fax 97850 0
Email 97850 0
[email protected]
Contact person for public queries
Name 97851 0
Michael Stitely
Address 97851 0
University of Otago. Department of Women's and Children's Health PO Box 56 Dunedin 9013 NewZealand
Country 97851 0
New Zealand
Phone 97851 0
+64 027 6678852
Fax 97851 0
Email 97851 0
[email protected]
Contact person for scientific queries
Name 97852 0
Michael Stitely
Address 97852 0
University of Otago. Department of Women's and Children's Health PO Box 56 Dunedin 9013 NewZealand
Country 97852 0
New Zealand
Phone 97852 0
+64 27 667 8852
Fax 97852 0
Email 97852 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Will be available freely from web-site.

Conditions for requesting access:
• -

What individual participant data might be shared?
• Patient demographics, satisfaction score results (UDI-6), adverse events, urinary retention occurrences,

What types of analyses could be done with individual participant data?
• Meta-analysis and retrospective research.

When can requests for individual participant data be made (start and end dates)?
From:
1 July 2023 and ongoing.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• De-identified data will be placed into a research data repository such as Harvard Dataverse or FigShare once a manuscript is submitted for publication.

Are there extra considerations when requesting access to individual participant data?
No


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.