Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices (CAPTURE)

To monitor post-market performance through evaluation of short and long-term performance via:

• Efficacy
• Safety
• Patient reported outcomes

Study Overview

• Status: Terminated
• Conditions: Pelvic Organ Prolapse; Female Stress Incontinence
• Intervention / Treatment: Device: Elevate PC; Device: Mini Arc Pro; Device: RetroArc

Detailed Description

As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:

• Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
• Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
• Collect concomitant procedural data related to the pelvic floor area

• Study Type: Observational
• Enrollment (Actual): 401

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 7W9
      • The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Research Office
• France
  • Montpellier, France, 34070
    • CMC Beau Soleil
  • Paris, France
    • Hôpital Bicêtre
• Germany
  • Berlin, Germany, 11 10115
    • German Pelvic Floor Center, St. Hedwig Hospital
  • Tettnang, Germany, 16 88069
    • Waldburg-Zeil Kliniken Klinik Tettnang
• Slovenia
  • Maribor, Slovenia
    • University Medical Centre Maribor
• South Africa
  • Pretoria, South Africa
    • Pretoria Urology Hospital
• Spain
  • Barcelona, Spain
    • Hospital Clínico y Provincial de Barcelona
  • Madrid, Spain
    • Hospital Beata Maria Ana de Jesus
  • Valladolid, Spain
    • Hospital Rio Hortega
• United Kingdom
  • Bolton, United Kingdom
    • Royal Bolton Hospital
  • Glasgow, United Kingdom
    • Glasgow - Southern General Hospital
• United States
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Atlanta Medical Research Institute
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Morristown Memorial Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • WomanCare
  • Ohio
    • Cinncinatti, Ohio, United States, 45242
      • Seven Hills Women's Health Centers
  • Pennsylvania
    • Newtown, Pennsylvania, United States, 18940
      • The Female Pelvic Health Center
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Female Pelvic Medicine Institute of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.

Description

Inclusion Criteria:

• Patients must meet all of the following criteria to be considered for inclusion in the registry.

  • Have a signed Informed Consent Form
  • Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
  • Is a female at least 18 years of age
  • Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
  • Is able and willing to participate in the registry

Exclusion Criteria:

• Patients will be excluded from the registry if any one of the following criteria is met.

  • Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Elevate PC; Subjects implanted with Elevate PC	Device: Elevate PC; List of AMS prolapse products
Mini Arc Pro; Subjects implanted with Mini Arc Pro	Device: Mini Arc Pro; List of AMS Urinary Incontinence devices
RetroArc; Subjects implanted with RetroArc	Device: RetroArc; List of AMS Urinary Incontinence devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse Efficacy - POP-Q	Prolapse Endpoints: • POP-Q measurement	annually, upto 5 years
Urinary Incontinence Endpoints	Urinary Incontinence Endpoints: Cough stress test; 1 hour pad weight test; Urodynamics	annually upto 5 years

Collaborators and Investigators

• Sponsor: ASTORA Women's Health

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: prolapse; incontinence; POP; SUI; vaginal repair; urinary slings
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Pathological Conditions, Anatomical; Urinary Incontinence; Prolapse; Pelvic Organ Prolapse; Urinary Incontinence, Stress
• Other Study ID Numbers: PR1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO