- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00627549
Avaulta Versus Anterior Repair
The Use of Avaulta Plus for Anterior Repair. A Multicenter Randomised Prospective Controlled Study
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.
Study Overview
Status
Conditions
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Martin Rudnicki, professor
- Phone Number: +4547324007
Study Locations
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Roskilde, Denmark, 4000
- Roskilde University Hospital
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Contact:
- Martin Rudnicki, Professor
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Contact:
- Ulla Hviid, MD
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Principal Investigator:
- Martin Rudnicki, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 2
|
Anterior repair surgery
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Active Comparator: 1
|
The use of Avaulta
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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one year
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. A 3-year follow-up after anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2016 Jan;123(1):136-42. doi: 10.1111/1471-0528.13628. Epub 2015 Sep 30.
- Teleman P, Laurikainen E, Kinne I, Pogosean R, Jakobsson U, Rudnicki M. Relationship between the Pelvic Organ Prolapse Quantification system (POP-Q), the Pelvic Floor Impact Questionnaire (PFIQ-7), and the Pelvic Floor Distress Inventory (PFDI-20) before and after anterior vaginal wall prolapse surgery. Int Urogynecol J. 2015 Feb;26(2):195-200. doi: 10.1007/s00192-014-2434-6. Epub 2014 May 28.
- Rudnicki M, Laurikainen E, Pogosean R, Kinne I, Jakobsson U, Teleman P. Anterior colporrhaphy compared with collagen-coated transvaginal mesh for anterior vaginal wall prolapse: a randomised controlled trial. BJOG. 2014 Jan;121(1):102-10; discussion 110-1. doi: 10.1111/1471-0528.12454. Epub 2013 Oct 1.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Avaulta 17431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Vaginal Prolapse
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