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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00388947
First received: October 16, 2006
Last updated: October 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Vaginal Prolapse
Device: AMS Prolapse Product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by American Medical Systems:

Primary Outcome Measures:
  • Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device [ Time Frame: up to 2-years post-implant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Prolapse Efficacy Success Rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 1543
Study Start Date: September 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388947

Locations
United States, Massachusetts
Samuel Zylstra, MD
Whitinsville, Massachusetts, United States, 01588
Sponsors and Collaborators
American Medical Systems
Investigators
Principal Investigator: Samuel Zylstra, MD Whitinsville Medical Center
  More Information

No publications provided

Responsible Party: American Medical Systems
ClinicalTrials.gov Identifier: NCT00388947     History of Changes
Other Study ID Numbers: 1012
Study First Received: October 16, 2006
Results First Received: August 3, 2012
Last Updated: October 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Medical Systems:
vaginal prolapse
cystocele
rectocele
enterocele
apical prolapse
vaginal vault prolapse

Additional relevant MeSH terms:
Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 20, 2014