NCT00774215

Brief Summary

This study is a 1 year review of all patients who had surgery to correct pelvic organ prolapse (i.e. cystocele, rectocele, enterocele) using the Avaulta synthetic mesh kit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

January 26, 2010

Status Verified

October 1, 2008

Enrollment Period

1.5 years

First QC Date

October 16, 2008

Last Update Submit

January 25, 2010

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ ProlapseCystoceleRectoceleEnteroceleSynthetic MeshVaginal MeshTransobturator

Outcome Measures

Primary Outcomes (1)

  • Anatomical success rates 1 year after surgery to correct pelvic organ prolapse with the Avaulta synthetic mesh kit

    1 year post operatively

Secondary Outcomes (1)

  • Mesh complications 1 year after surgery with the Avaulta synthetic mesh kit

    1 year

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

You may qualify if:

  • All patiAll patients who underwent surgery with the Avaulta synthetic mesh kit from 1/06 - 4/08.

You may not qualify if:

  • Unable to give informed consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantic Health System - Division of Urogynecology

Morristown, New Jersey, 07960, United States

Location

Related Publications (1)

  • 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.

    PMID: 24118844DERIVED

Related Links

MeSH Terms

Conditions

Pelvic Organ ProlapseCystoceleRectoceleHernia

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesRectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 17, 2008

Study Start

October 1, 2007

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

January 26, 2010

Record last verified: 2008-10

Locations

US(1)