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Trial registered on ANZCTR


Registration number
ACTRN12611001151921
Ethics application status
Approved
Date submitted
22/10/2011
Date registered
2/11/2011
Date last updated
5/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Tension free vaginal tape (TVT) Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence – a Randomised Controlled Trial
Scientific title
In female patients with Stress Urinary Incontinence, is MiniArc as good as Tension free vaginal Tape (TVT) Abbrevo in objective cure rates?
Secondary ID [1] 273253 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Female stress urinary incontinence 279017 0
Condition category
Condition code
Renal and Urogenital 279203 279203 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
TVT Abbrevo suburethral sling
a monofilament synthetic polypropylene tape (permanent) is placed underneath the (mid) urethra, during this 20min operation
Tvt Abbrevo is around 15cm long and is placed tension free
Intervention code [1] 269593 0
Treatment: Surgery
Intervention code [2] 269594 0
Treatment: Devices
Comparator / control treatment
Miniarc suburethral sling
a monofilament synthetic polypropylene tape (permanent) is placed underneath the (mid) urethra, during this 20min (approx) operation
Miniarc is a 9cm mini sling with an innovative anchor to keep it in place
Control group
Active

Outcomes
Primary outcome [1] 279838 0
objective cure rate for stress urinary incontinence

Definition of cure: negative cough stress test
Timepoint [1] 279838 0
6 months, 12months, 24 months, 36 months
Secondary outcome [1] 294542 0
subjective cure rate for stress urinary incontinence using ICIQ UI SF questionnare
Timepoint [1] 294542 0
6 months, 12months, 24 months, 36 months
Secondary outcome [2] 294543 0
subjective overactive bladder rate using ICIQ OAB
Timepoint [2] 294543 0
6 months, 12months, 24 months, 36 months
Secondary outcome [3] 294544 0
incontinence impact using IIQ7
Timepoint [3] 294544 0
6 months, 12months, 24 months, 36 months
Secondary outcome [4] 294545 0
global impression of improvement using PGI-I
Timepoint [4] 294545 0
6 months, 12months, 24 months, 36 months
Secondary outcome [5] 294546 0
sexual function using PISQ12
Timepoint [5] 294546 0
6 months, 12months, 24 months, 36 months

Eligibility
Key inclusion criteria
1. female patients with urodynamic stress incontinence Or Stress Urinary incontinence
2. Willing to participate and return for follow up
3. able to provide informed consent
Minimum age
18 Years
Maximum age
80 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Evidence of intrinsic sphincter deficiency
2.Previous failed suburethral tapes
3.Untreated Detrusor overactivity
4.Significant voiding dysfunction
5.Lower urinary tract anomaly (congenital)
6.Neurogenic bladder disorders
7.Previous radiation therapy to pelvis
8.Past history of any form of fistula involving the vagina
9.Allergy to polypropylene or local anaesthetic

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients is enrolled at urodynamic clinic, when they are assessed for suitability for surgery for their stress urinary incontinence. Allocation is random and involved contacting the holder of the allocation schedule who was at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated table, stratified to centre
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284080 0
Self funded/Unfunded
Name [1] 284080 0
Address [1] 284080 0
Country [1] 284080 0
Australia
Primary sponsor type
Individual
Name
Anna Rosamilia
Address
Suite 8, Cabrini Medical Centre Malvern, 183 Wattletree Road, VIC 3144
Country
Australia
Secondary sponsor category [1] 269047 0
Individual
Name [1] 269047 0
Joseph Lee
Address [1] 269047 0
Pelvic Floor Clinic, Monash Moorabbin
823-865 Centre Road, East Bentleigh VIC 3165
Country [1] 269047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272038 0
Research Directorate, Southern Health HREC
Ethics committee address [1] 272038 0
Research Directorate, Southern Health
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 272038 0
Australia
Date submitted for ethics approval [1] 272038 0
Approval date [1] 272038 0
04/01/2012
Ethics approval number [1] 272038 0
11261B

Summary
Brief summary
Female stress urinary incontinence, which is exertional or activity related urinary incontinence commonly brought on by coughing and sneezing, is both common and have a high burden of suffering. The traditional operation to treat stress urinary incontinence has been open colposuspension, which involve an abdominal skin incision and a hospital stay of at least 5 days. Modern advances involve development of minimally invasive procedures which saw the introduction of tension free vaginal tapes (TVT) and transobturator tape (e.g. Monarc, TVT Obturator) which provides good success rates when compared to the traditional operation, although with the advantage of a quicker recovery. These procedures involve inserting slings made of synthetic material underneath the water pipe (urethra) to provide support. They exit through the abdomen, in the case of TVT or through the groin in the case of Monarc. Although these operations work very well, they do come with known complications such as bleeding and bladder injury, voiding difficulty or thigh pain. Whilst similar to the Monarc procedure, MiniArc it is placed using a very small incision and has no exit site. TVT Abbrevo is similar to the established TVT Obturator, except it comes with a shorter sling that do not come into potential contact with the thigh muscles thereby reducing risk of groin pain. The purpose of this project is to evaluate the success of these two types of surgical procedures (MiniArc and TVT Abbrevo) in the treatment of women with stress urinary incontinence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33296 0
Address 33296 0
Country 33296 0
Phone 33296 0
Fax 33296 0
Email 33296 0
Contact person for public queries
Name 16543 0
Alison Leitch
Address 16543 0
pelvic floor clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 16543 0
Australia
Phone 16543 0
+61399288588
Fax 16543 0
+61399288338
Email 16543 0
Alison.Leitch@southernhealth.org.au
Contact person for scientific queries
Name 7471 0
Joseph Lee
Address 7471 0
pelvic floor clinic
Monash Moorabbin
823-865 Centre Road
East Bentleigh VIC 3165
Country 7471 0
Australia
Phone 7471 0
+61399288588
Fax 7471 0
+61399288338
Email 7471 0
joseph.lee@southernhealth.org.au

No information has been provided regarding IPD availability
Summary results
No Results