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OpenTrials
Completed

NCT Number: NCT00388947

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

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.

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Key information

Conditions

Vaginal Prolapse Cystocele Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Genital Diseases Genital Diseases, Female Hernia Intestinal Diseases Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Rectocele Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Uterine Diseases Uterine Prolapse

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Samuel Zylstra, MD

Whitinsville, Massachusetts, 01588, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AMS Prolapse Product

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ASTORA Women's Health

Industry

Registry information

Official study 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

Acronym: POWER1012

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 17, 2006
Registry last updated
Aug 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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