Avaulta versus voorwand
A randomised controlled trial comparing the clinical and cost-effectiveness of the Avaulta® anterior mesh and the standard anterior colporrhaphy for the primary surgical treatment of a cystocele stage ≥ 2.
Go to the Avaulta website.
After a standard surgical anterior colporrhaphy for an anterior vaginal wall prolapse (cystocele) grade 2 or higher, one-third of women will have an anatomical recurrence within 2 years after primary surgery. The use of a non-absorbable synthetic polypropylene mesh has been shown to be effective in repeat surgery for genital prolapse, with a recurrence rate between 3-12%. However, a comparative study between the anterior colporrhaphy and surgery with a non-absorbable synthetic mesh as primary treatment for an anterior vaginal wall prolapse has not been conducted.
Multicentre prospective randomised controlled multidisciplinary trial.
Women 40 -80 years of age with a cystocele stage 2 or higher, according to the POPQ classification, who are scheduled for primary surgery.
Women are either allocated to a group who will undergo a classic anterior colporraphy repair or a group in which the Avaulta mesh is used.
The primary endpoint of the study is the number of women who will have a recurrence, defined as a stage ≥ 2 anterior vaginal prolapse at 2 years follow-up. Secundary endpoints are:
POWER / DATA ANALYSIS:
Assuming that in the standard anterior colporrhaphy group 35% of women will have a recurrent cystocele stage ≥ 2 at the 2 year follow up and an estimated recurrence rate of 10% in the Avaulta anterior group , 50 women have to be assigned to each group (power 0,80, alpha 0.05). With an estimated drop-out of 15%, a total of 115 women have to be randomized.
38 months: 12 months for inclusion, 24 months follow-up and 2 months analysis and report.
A. Vollebregt, Spaarne Ziekenhuis Hoofddorp
Alant Vrouw, Bilthoven
Spaarne Ziekenhuis, Hoofddorp
Amphia Ziekenhuis, Breda