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The Use of Avaulta for Anterior Repair

NCT00918099 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2009-06-11

No results posted yet for this study

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. The investigators 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 the investigators' standard treatment.

Conditions

  • Vaginal Prolapse

Interventions

PROCEDURE

Avaulta mesh

Insertion of a mesh vs conventional repair

PROCEDURE

Anterior repair

Conventional repair

Sponsors & Collaborators

  • Zealand University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00918099 on ClinicalTrials.gov