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

Vaginal Prolapse Clinical Trial

— POWER1012  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00388947
• Other study ID #: 1012
• Status: Completed
• Phase: N/A
• First received: October 16, 2006
• Last updated: October 16, 2012
• Start date: September 2006
• Est. completion date: May 2010

Study information

• Verified date: August 2012
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1543
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prolapse
• Uterine Prolapse
• Vaginal Prolapse

Intervention

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

Locations

Country	Name	City	State
United States	Samuel Zylstra, MD	Whitinsville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device		up to 2-years post-implant	Yes
Secondary	Prolapse Efficacy Success Rate	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	No