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

NCT00388947 | Completed Results

• 1 other identifier: 1012
• Study Type: observational
• Target: 1,543
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Prolapse

Keywords

vaginal prolapse; cystocele; rectocele; enterocele; apical prolapse; vaginal vault prolapse

Outcome Measures

Primary Outcomes (1)

• Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device

  up to 2-years post-implant

Secondary Outcomes (1)

• Prolapse Efficacy Success Rate

  24 months

Study Arms (1)

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

Interventions

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

Also known as: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior

1

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (1)

Samuel Zylstra, MD

Whitinsville, Massachusetts, 01588, United States

Location

MeSH Terms

Conditions

Uterine Prolapse; Cystocele; Rectocele; Hernia; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr Samuel Zylstra
• Organization: Whitinsville Medical Center

samuelzylstra@milreg.org

508-243-6260

Study Officials

• Samuel Zylstra, MD

  Whitinsville Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2006
• First Posted: October 17, 2006
• Study Start: September 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 11, 2016
• Results First Posted: November 20, 2012

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)