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CompletedNCT00774215Updated Jan 26, 2010

Evaluation of the Avaulta Procedure for the Correction of Pelvic Organ Prolapse - Results at 1 Year

An observational study in Pelvic Organ Prolapse, sponsored by Atlantic Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-01-26.

Sponsored by Atlantic Health System · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
103
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

This is a retrospective cohort analysis of all patients who experienced vaginal prolapse and were operated on with the Avaulta synthetic vaginal mesh "kit" from January 2006 to April 2007. The Avaulta synthetic mesh is composed of polypropylene which is a monofilament. The objective of this trial is to compare patients objectively and subjectively at least one year after placement of the Avaulta synthetic vaginal mesh in terms of prolapse symptoms.

This data will be compared to pre-operative data already collected for these patients as a part of their routine surgical work-up. Mesh-related complications will be quantified, including erosions, new-onset pain, and infections. Success and anatomic recurrence rates will be recorded as well

02

Conditions studied

  • Pelvic Organ Prolapse

Keywords

  • Pelvic Organ Prolapse
  • Cystocele
  • Rectocele
  • Enterocele
  • Synthetic Mesh
  • Vaginal Mesh
  • Transobturator
03

In context

Pelvic Organ Prolapse

516 studies on the registry are indexed under Pelvic Organ Prolapse; 80 are open to participants now.

This study's planned enrollment of 103 is below the median of 131 across 168 observational studies indexed under Pelvic Organ Prolapse.

Browse Pelvic Organ Prolapse studies →

Lead sponsor

Atlantic Health System is the lead sponsor of 63 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Unable to give informed consent to participate
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
103 participants (estimated)
06

What researchers measure

Primary outcomes

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

    Time frame: 1 year post operatively

Secondary outcomes

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

    Time frame: 1 year

07

Study locations

1 site
  • Atlantic Health System - Division of Urogynecology
    Morristown, New Jersey 07960, United States
08

References and documents

Publications

  • 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. PubMed 24118844 ↗

Related links

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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2007, a primary completion of Apr 2009 and a completion of Apr 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2008
First posted
Oct 17, 2008
Start
Oct 2007
Primary completionActual
Apr 2009
CompletionActual
Apr 2009
Last update
Jan 26, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00774215
Lead sponsor
Atlantic Health System
First posted
Oct 17, 2008
Start date
Oct 2007
Primary completion
Apr 2009
Completion
Apr 2009
Last update
Jan 26, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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