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Tension free vaginal tape (TVT) Abbrevo and Miniarc suburethral sling in women with stress urinary incontinence – a Randomised Controlled Trial

In female patients with Stress Urinary Incontinence, is MiniArc as good as Tension free vaginal Tape (TVT) Abbrevo in objective cure rates?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611001151921
Enrollment
230
Registered
2011-11-02
Start date
2011-12-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Sponsors

Anna Rosamilia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026