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

ASTORA Women's Health401 enrolled

Overview

To monitor post-market performance through evaluation of short and long-term performance via: * Efficacy * Safety * Patient reported outcomes

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

401

Conditions

Female Stress Incontinence Pelvic Organ Prolapse

Interventions

Elevate PCDEVICE

List of AMS prolapse products

Mini Arc ProDEVICE

List of AMS Urinary Incontinence devices

RetroArcDEVICE

List of AMS Urinary Incontinence devices

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Atlanta Medical Research Institute

Alpharetta, Georgia, United States

Morristown Memorial Hospital

Morristown, New Jersey, United States

Outcomes

Primary Outcomes

Prolapse Efficacy - POP-Q

Prolapse Endpoints: • POP-Q measurement

Time frame: annually, upto 5 years

Urinary Incontinence Endpoints

Urinary Incontinence Endpoints: * Cough stress test * 1 hour pad weight test * Urodynamics

Time frame: annually upto 5 years

Data from ClinicalTrials.gov

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