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Trial registered on ANZCTR


Registration number
ACTRN12620000900910
Ethics application status
Approved
Date submitted
21/07/2020
Date registered
11/09/2020
Date last updated
11/09/2020
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
Gender
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
Not yet recruiting
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] 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
Address [1] 304222 0
Women's and Children's Health
PO Box 56
Dunedin 9054
New Zealand
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
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
New Zealand
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
Five subjects will be treated with a modification to the traditional way in which a pubo-vaginal sling procedure is performed.

Our modification to the technique involves using a new method to attach the sling so that the abdominal incision to secure the tension on the sling is not necessary. The sling anchor then dissolves over time as healing is complete. The sling tissue will be collected from the patient’s lateral thigh as is the usual for this procedure.
The study is designed to be a small feasibility study to test that the modification of the procedure for anchoring the sling functions as intended.
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
+64 3 479 9750
Fax 97850 0
Email 97850 0
michael.stitely@otago.ac.nz
Contact person for public queries
Name 97851 0
A/Prof 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 3 479 9750
Fax 97851 0
Email 97851 0
michael.stitely@otago.ac.nz
Contact person for scientific queries
Name 97852 0
A/Prof 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 3 479 9750
Fax 97852 0
Email 97852 0
michael.stitely@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient demographics, satisfaction score results (UDI-6), adverse events, urinary retention occurrences,
When will data be available (start and end dates)?
1 June 2021 and ongoing.
Available to whom?
Will be available freely from web-site.
Available for what types of analyses?
Meta-analysis and retrospective research.
How or where can data be obtained?
De-identified data will be placed into a research data repository such as Harvard Dataverse or FigShare once a manuscript is submitted for publication.
What supporting documents are/will be available?
No other documents available
Summary results
No Results