Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products (POWER1012)

July 11, 2016 updated by: ASTORA Women's Health

The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data.

The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).

Study Type

Observational

Enrollment (Actual)

1543

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Whitinsville, Massachusetts, United States, 01588
        • Samuel Zylstra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female subjects greater than or equal to 21 years of age with genital prolapse who undergo surgical reconstruction of the pelvic floor using an AMS Prolapse Repair device.

Description

Inclusion Criteria:

  • Female at least 21 years old
  • Has pelvic organ prolapse requiring surgical repair
  • Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse

Exclusion Criteria:

  • Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
AMS Prolapse Product (AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family)
Device: AMS Prolapse Product
AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family
Other Names:
  • Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
Time Frame: up to 2-years post-implant
up to 2-years post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prolapse Efficacy Success Rate
Time Frame: 24 months
Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ASTORA Women's Health

Investigators

  • Principal Investigator: Samuel Zylstra, MD, Whitinsville Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 16, 2006

First Submitted That Met QC Criteria

October 16, 2006

First Posted (Estimate)

October 17, 2006

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

July 11, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1012 (Registry Identifier: NNGYK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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