Avaulta Versus Anterior Repair
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|ClinicalTrials.gov Identifier: NCT00627549|
Recruitment Status : Unknown
Verified February 2008 by Zealand University Hospital.
Recruitment status was: Not yet recruiting
First Posted : March 3, 2008
Last Update Posted : March 3, 2008
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 or disease||Intervention/treatment||Phase|
|Vaginal Prolapse||Procedure: Avaulta (surgical procedure using a mesh implant) Procedure: Conventional surgery (anterior repair)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627549
|Contact: Martin Rudnicki, professor||+4547324007|
|Roskilde University Hospital||Not yet recruiting|
|Roskilde, Denmark, 4000|
|Contact: Martin Rudnicki, Professor|
|Contact: Ulla Hviid, MD|
|Principal Investigator: Martin Rudnicki, Professor|