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

Completed

• Conditions: Vaginal Prolapse

• Registration Number: NCT00388947
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-10-16
• Study First Submitted QC: 2006-10-16
• Study First Posted: 2006-10-17
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2012-08-03
• Results First Submitted QC: 2012-10-16
• Results First Posted: 2012-11-20
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1543

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device	up to 2-years post-implant

Secondary Outcome Measures

Name	Time	Method
Prolapse Efficacy Success Rate	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.

Trial Locations

Locations (1)

Samuel Zylstra, MD; 🇺🇸 Whitinsville, Massachusetts, United States