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Avaulta Versus Anterior Repair

The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00627549
Enrollment
Unknown
Registered
2008-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2008-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Prolapse

Keywords

cystocele, anterior repair, mesh

Brief summary

Summary: Vaginal prolapse is a well-known disease and is observed in approximately 11% of all postmenopausal women and tending to increase with age. Consequently, many surgical procedures have been developed in order to ensure sufficient support for the bladder, rectum or vaginal vault depending on the site of the defect. However, many procedures are associated with a high recurrence rate up to 40 % even within one to two years after the surgical procedure. Due to the high recurrence rate new methods include the use of mesh, either biologically or synthetic. The latter is a permanent implant and therefore theoretically may result in a long-lasting anatomically correct position of the prolapse. Although the recurrence rate may be lower using a mesh such surgical procedures may be associated with adverse events such as erosions of the vaginal mucosa. Others have observed shrinkage of the vaginal mucosa. However, in these studies large prolene mesh have been used. In contrast the recurrence rate is lowered up to 25%. The above-mentioned advantage of synthetic mesh is however, mostly based on few non-randomised studies. We therefore find it of importance to evaluate whether a surgical procedure using a mesh implant is superior to conventional surgical techniques. The present study is a clinical controlled study where patients with anterior vaginal prolapse are randomised to either a mesh technique or a standard anterior procedure. The present study includes only two more visits at the outpatient clinic after the surgical procedure. Furthermore the patients have to fulfil questionnaires regarding urinary and faecal leakage and sexual habits. Any participation in the study is totally voluntary and the patient may at any time withdraw herself. In any case the patient will receive our standard treatment. The study is performed in all the Scandinavian countries.

Interventions

PROCEDUREAvaulta (surgical procedure using a mesh implant)

The use of Avaulta

PROCEDUREConventional surgery (anterior repair)

Anterior repair surgery

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Women aged \> 55 yr * Women with anterior vaginal wall prolapse stage \>2 according to POP-Q classification * Good understanding the language in word and writing

Exclusion criteria

* A history of previous major pelvic surgery with the exception of a hysterectomy for reasons other than genital prolapse * Patients with previous vaginal surgery because of defects in the anterior of posterior compartments * Previous hysterectomy because of vaginal prolapse * Patients with prolapse of uterus or an enterocele \> stage 2 * Patients with previous TVT performed through the obturator membrane * History of genital or abdominal cancer * Patients treated with corticosteroids * Not able to understand the study protocol (language problems, cognitive dysfunction etc.)

Design outcomes

Primary

MeasureTime frame
Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr.one year

Countries

Denmark

Contacts

Primary ContactMartin Rudnicki, professor
+4547324007

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026