Cystocele and Stress Urinary Incontinence(SUI):Simultaneous repair (Sim-Pair) by a modified surgical technique using transobturator mesh -Prospective study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000596303

Acronym

SIM-PAIR study

Enrollment

Registered

2008-12-01

Start date

2008-07-01

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

This is a study to assess the efficacy and safety of using one single mesh to treat both bladder prolapse and stress urinary incontinence as one operation. We hope the cure of stress urinary incontinence(SUI) will be comparable to other meshes used to treat SUI alone.

Interventions

Simultaneous repair of cystocoele and treatment of SUI using Transobturator Mesh system(Perigee) via anterior vaginal wall incision and 4 exit points in the crural fold bilaterally (2 on each side). Patients are then followed up for a total of 24 months.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Women presenting with stage 2 or more bladder prolapse (cystocele) and Stress Urinary Incontinence[revealed and occult] who desire reconstructive surgery,

Exclusion criteria

Women with less than stage 2 prolapseWomen who do not demonstrate SUIWomen with Intrinsic sphincter deficiency ( defined as maximum urethral closure pressure of more than orequal to 20 cm of water)Women less than 18 yrsWomen who decline participationWomen unable to give informed consentWomen with previous mesh based repair for bladder prolapse

Outcome results