Status:
UNKNOWN
The Use of Avaulta for Anterior Repair
Lead Sponsor:
Zealand University Hospital
Conditions:
Vaginal Prolapse
Eligibility:
FEMALE
55+ years
Phase:
NA
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 d...
Detailed Description
RESEARCH PROTOCOL: The use of Avaulta for anterior repair. A multicenter randomised prospective controlled study. BACKGROUND: During the resent years the methods for pelvic organ prolapse repair ha...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00918099
Start Date
October 1 2008
End Date
July 1 2010
Last Update
June 11 2009
Active Locations (1)
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1
Roskilde University Hospital
Roskilde, Denmark, 4000