Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000616471p
Ethics application status
Submitted, not yet approved
Date submitted
8/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study of a Bioengineered Animal Tissue Graft Urinary Incontinence Sling
Scientific title
A descriptive study to determine the feasibility of a minimally-invasive non-mesh incontinence sling procedure using a bioengineered
animal tissue graft in adults with urodynamic stress incontinence.
Secondary ID [1] 314408 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress urinary incontinence 337417 0
Condition category
Condition code
Renal and Urogenital 333796 333796 0 0
Other renal and urogenital disorders
Surgery 333797 333797 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Performance of a pubo-vaginal sling to be tension adjusted using a knotless fixation mechanism without using an abdominal incision. The sling graft will be a bioengineered animal tissue graft with regulatory approval for surgical implantation (Myriad Matrix, Aroa Biosurgery, Auckland, NZ).
The intervention will be performed by a subspecialist Urogynaecologist or a Gynaecologist who completed an Advanced Training Module in Urogynaecology who has surgical credentials to perform pubo-vaginal sling procedures.

Mode of care delivery is surgical, provided in operating theatre, with single episode provision of care lasting approximately 30 minutes, 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 a tissue graft as described above which is anchored using a knotless fixation method using polydioxanone sulphate barbed suture. The biograft will be fully integrated within 120 days, 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] 331013 0
Treatment: Surgery
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341375 0
Feasibility will be determined to be : Patient reported success of the procedure of greater than or equal to 70% reporting an improvement on the overall UDI-6 score. This assessment is conducted by directly asking the participant about this outcome.
Timepoint [1] 341375 0
Baseline, 42-56 days post-procedure.
Primary outcome [2] 341376 0
Percentage of participants with urinary retention requiring catheter usage for longer than 4 weeks.
Timepoint [2] 341376 0
42-56 Days post-surgery at first post-operative follow-up visit
Secondary outcome [1] 447346 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] 447346 0
Day of surgery.
Secondary outcome [2] 447347 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] 447347 0
Baseline, 42-56 days post-operative, 6 months post-operative, 12 months post-operative.
Secondary outcome [3] 447348 0
Post-void residual urine volume
Timepoint [3] 447348 0
42-56 days post-operative.

Eligibility
Key inclusion criteria
Adult people with urodynamic stress urinary incontinence who would otherwise be a candidate for an incontinence 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.
Lack of a patent vagina.
Chronic vaginal or pelvic pain.
Inability to give informed consent.
Current pregnancy.

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)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics only as no comparator group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2025
Actual
Date of last participant enrolment
Anticipated
31/07/2026
Actual
Date of last data collection
Anticipated
31/07/2027
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 27055 0
New Zealand
State/province [1] 27055 0

Funding & Sponsors
Funding source category [1] 318929 0
Charities/Societies/Foundations
Name [1] 318929 0
Healthcare Otago Trust
Country [1] 318929 0
New Zealand
Primary sponsor type
Government body
Name
Health New Zealand (Investigator initiated study)
Address
Country
New Zealand
Secondary sponsor category [1] 321666 0
None
Name [1] 321666 0
None
Address [1] 321666 0
Country [1] 321666 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317542 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 317542 0
Ethics committee country [1] 317542 0
New Zealand
Date submitted for ethics approval [1] 317542 0
06/05/2025
Approval date [1] 317542 0
Ethics approval number [1] 317542 0

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

Contacts
Principal investigator
Name 141382 0
Mr Elliot MacKenzie
Address 141382 0
Dunedin Hospital. Gynaecology Department. Private Bag 1921. Dunedin 9054
Country 141382 0
New Zealand
Phone 141382 0
+64 03 474 0999
Fax 141382 0
Email 141382 0
[email protected]
Contact person for public queries
Name 141383 0
Michael Stitely
Address 141383 0
Southland Hospital. Gynaecology Department. PO Box 828. Invercargill 9840
Country 141383 0
New Zealand
Phone 141383 0
+64 03 218 1949
Fax 141383 0
Email 141383 0
[email protected]
Contact person for scientific queries
Name 141384 0
Michael Stitely
Address 141384 0
Southland Hospital. Gynaecology Department. PO Box 828. Invercargill 9840
Country 141384 0
New Zealand
Phone 141384 0
+64 03 218 1949
Fax 141384 0
Email 141384 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:
• Anyone

• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
• Published results
• Primary outcome(s)
• Safety data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: Harvard Dataverse data repository.

• Journal publication or its supplementary materials: A journal in the field of Gynaecology, not yet determined.

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.