Avaulta Versus Anterior Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Roskilde County Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Roskilde County Hospital
ClinicalTrials.gov Identifier:
NCT00627549
First received: February 22, 2008
Last updated: February 29, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention
Vaginal Prolapse
Procedure: Avaulta (surgical procedure using a mesh implant)
Procedure: Conventional surgery (anterior repair)

Study Type: Interventional
Official Title: The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study

Further study details as provided by Roskilde County Hospital:

Primary Outcome Measures:
  • Does Avaulta Plus reduce the recurrence rate defined as a POP-Q Aa <-2 cm at follow-up after 1 yr. [ Time Frame: one year ] [ Designated as safety issue: No ]

Arms Assigned Interventions
Active Comparator: 1 Procedure: Avaulta (surgical procedure using a mesh implant)
The use of Avaulta
Active Comparator: 2 Procedure: Conventional surgery (anterior repair)
Anterior repair surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627549

Contacts
Contact: Martin Rudnicki, professor +4547324007

Locations
Denmark
Roskilde University Hospital Not yet recruiting
Roskilde, Denmark, 4000
Contact: Martin Rudnicki, Professor         
Contact: Ulla Hviid, MD         
Principal Investigator: Martin Rudnicki, Professor         
Sponsors and Collaborators
Roskilde County Hospital
  More Information

No publications provided by Roskilde County Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00627549     History of Changes
Other Study ID Numbers: Avaulta 17431
Study First Received: February 22, 2008
Last Updated: February 29, 2008
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Roskilde County Hospital:
cystocele, anterior repair, mesh

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on August 19, 2014