The Use of Avaulta for Anterior Repair

NCT00918099 | Unknown DMC

• 1 other identifier: Avaulta
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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. 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

Keywords

Mesh; vaginal prolapse; Recurrence rate

Outcome Measures

Primary Outcomes (1)

• Does Avaulta reduce the recurrence rate

  0ct 2008 - July 2010

Secondary Outcomes (1)

• Does Avaulta improve prolapse symptoms, quality of life and sexual function

  oct 2008-July 2010

Study Arms (2)

Avaulta mesh

ACTIVE COMPARATOR

Avaulta mesh

Procedure: Avaulta mesh

Anterior repair

ACTIVE COMPARATOR

Anterior repair

Procedure: Anterior repair

Interventions

Avaulta mesh PROCEDURE

Insertion of a mesh vs conventional repair

Avaulta mesh

Anterior repair PROCEDURE

Conventional repair

Anterior repair

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• A history of pervious 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 1
• Patients with previous TVT performed through the obturator membrane
• History of genital or abdominal cancer
• Patients treated with corticostaroids
• Not able to understand the study protocol (language problems, cognitive dysfunction etc.)

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Roskilde University Hospital

Roskilde, 4000, Denmark

RECRUITING

MeSH Terms

Conditions

Uterine Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Martin Rudnicki, ass professor

CONTACT

+4547324007; pmru@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: June 11, 2009

Record last verified: 2009-06

Locations

DK (1)