Avaulta Versus Anterior Repair

Vaginal Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00627549
• Other study ID #: Avaulta 17431
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2008
• Last updated: February 29, 2008

Study information

• Verified date: February 2008
• Source: Roskilde County Hospital
• Contact: Martin Rudnicki, professor
• Phone: +4547324007
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.)

Study Design

N/A

Related Conditions & MeSH terms

• Vaginal Prolapse

Intervention

Procedure:
• Avaulta (surgical procedure using a mesh implant)
The use of Avaulta
• Conventional surgery (anterior repair)
Anterior repair surgery

Locations

Country	Name	City	State
Denmark	Roskilde University Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Roskilde County Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr.		one year	No