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MiniArc and Monarc suburethral sling in women with stress urinary incontinence - a randomised controlled trial

In female patients with Stress Urinary Incontinence, is MiniArc as good as Monarc in objective cure rates?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000624381
Enrollment
220
Registered
2008-12-09
Start date
2009-04-30
Completion date
2011-12-14
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

The purpose of this project is to evaluate the success of two types of surgical procedures in the treatment of women with exertional or activity related urinary incontinence, commonly brought on by coughing and sneezing. Modern advances involve development of minimally invasive procedures which saw the introduction of tension free vaginal tapes (TVT) and transobturator tape (e.g. Monarc) which provides good success rates when compared to the traditional operation, although with the advantage of a quicker recovery. Both the TVT and Monarc tape have a success rates in the order of 85-90% but do attract complications such as bleeding and bladder injury (4-9%) at the time of needle passage, difficulty in passing urine, urinary urgency (2.9%), mesh material making its way through to the vagina (1%) or thigh pain. The MiniArc sling is a procedure that places the tape in a different way. It is inserted through a small vaginal incision with no exit site and acts more as a “hammock”. It may have less complication than the Monarc slings because of its exitless design. We aim to compare the success rate of MiniArc versus Monarc slings in treatment of female stress urinary incontinence with the hypothesis that MiniArc has at least the equivalent success rate

Interventions

Intervention treatment - MiniArc - Exitless transobturator placement of suburethral sling with fixation tip at obturator membrane. Intervention is - MiniArc placement of suburethral sling. Follow up is scheduled for 6 weeks, 6 months, 12 months, 24 months and 36 months.

Sponsors

Professor Peter L Dwyer
Lead SponsorIndividual

Study design

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

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

female patients with urodynamic stress incontinence

Exclusion criteria

evidence of instrinsic sphincter deficiency previous failed suburethral tapes untreated detrusor overactivity, unfit for surgery, history genital tract malignancy or fistula, previous radiation to pelvis, known allergy to polypropylene

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026