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

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ClinicalTrials.gov Identifier: NCT00388947
Recruitment Status : Completed
First Posted : October 17, 2006
Results First Posted : November 20, 2012
Last Update Posted : August 11, 2016
Sponsor:
Information provided by (Responsible Party):
ASTORA Women's Health

Brief Summary:
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 or disease Intervention/treatment
Vaginal Prolapse Device: AMS Prolapse Product

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).


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Study Type : Observational
Actual Enrollment : 1543 participants
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
Study Start Date : September 2006
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


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 Name: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior




Primary Outcome Measures :
  1. Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device [ Time Frame: up to 2-years post-implant ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388947


Locations
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United States, Massachusetts
Samuel Zylstra, MD
Whitinsville, Massachusetts, United States, 01588
Sponsors and Collaborators
ASTORA Women's Health
Investigators
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Principal Investigator: Samuel Zylstra, MD Whitinsville Medical Center

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Responsible Party: ASTORA Women's Health
ClinicalTrials.gov Identifier: NCT00388947     History of Changes
Other Study ID Numbers: 1012
First Posted: October 17, 2006    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: August 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ASTORA Women's Health:
vaginal prolapse
cystocele
rectocele
enterocele
apical prolapse
vaginal vault prolapse
Additional relevant MeSH terms:
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Uterine Prolapse
Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse