A randomised trial comparing two vaginal prolene sling surgeries for female urinary incontinence

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000314820

Enrollment

Registered

2012-03-20

Start date

2012-01-01

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

50 females with urodynamically proven stress incontience will be randomised to either Monarc or Miniarc suburethral sling surgery and compared with regard to postoperative pain relief, blood loss, and continence at 6 months

Interventions

Suburethral sling surgery with randomisation to Monarc or Mini-arc. Both are surgical devices made of polypropylene that are placed underneath the mid urethra. Both procedures take about 20minutes, however the Monarch is more invasive with 3 incisions, whilst the Mini-arc only has a single incision.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

16 Years to 90 Years

Healthy volunteers

Inclusion criteria

no other surgery required, females only ages 16 - 90, urodynamically proven stress incontinence & fit for surgery

Exclusion criteria

prolapse, detrusor overactivity or voiding difficulty, unit for surgery

Outcome results