Comparison of outcome following surgery for pelvic organ prolapse using two different types of mesh grafts

Comparison of objective and subjective success rates following surgery using the anterior-Prolift and Perigee systems in women with multi compartment pelvic organ prolapse

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000112268

Enrollment

100

Registered

2009-02-18

Start date

2008-10-24

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

The purpose of the study is to compare the outcomes of the surgical treatment for pelvic organ prolapse using two different mesh grafts, namely the anterior Prolift(TM) and the Perigee(TM) systems. Women with genital prolapse who underwent surgery using one of these mesh systems were recruited in the study and the anatomical outcomes as well as subjective success, patients' satisfaction and complication rates were prospectively evaluated.

Interventions

Anterior vaginal repair using the anterior Prolift(TM) system (Ethicon Women’s Health and Urology, Somerville, NJ) and concminant procedures for the apical and posterior compartments and for stress urinary incontinence as required. The anterior Prolift system is a transvaginal surgical kit designed for the treatment of anterior vaginal wall prolapse. It consists of a synthetic mesh graft with four arms. The graft is placed between the bladder and the anterior vaginal wall without tension and the

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

Women with symptomatic stage 2 (POP-Q) or more anterior vaginal prolapse

Exclusion criteria

Stage 0 or 1 anterior vaginal support, ongoing pregnancy, prior mesh implantation and inability to give informed consent.

Outcome results