Anterior Colporrhaphy versus Transobturator mesh repair system for anterior vaginal wall prolapse - A Randomised Controlled Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000378325

Acronym

ACT trial

Enrollment

Registered

2008-08-01

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

To compare the safety and efficacy of traditional surgical repair (anterior colporrhaphy) with mesh based prosthetic devices (transobturator mesh) in the clinical management of bladder prolapse.

Interventions

Transobturator mesh repair system. This repair system has a soft polypropylene mesh in the middle with 4 limbs of high friction mesh( 2 superior and 2 inferior ). 2 limb per obturator foremen. This is a surgical procedure Subjects undergoes only one procedure.

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 No maximum

Healthy volunteers

Inclusion criteria

Women presenting with stage 2 or more bladder prolapse (cystocele) and who desire reconstructive surgery, older than 18 yrs, available for follow up for 3 yrs, able to give informed consent

Exclusion criteria

Women with less than stage 2 prolapse Women less than 18 yrs Women who decline participation Women unable to give informed consent Women with previous mesh based repair for bladder prolapse

Outcome results