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

Terminated

• Conditions: Pelvic Organ Prolapse; Female Stress Incontinence

• Registration Number: NCT01673360
• Lead Sponsor: ASTORA Women's Health

Brief Summary

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

* Efficacy

* Safety

* Patient reported outcomes

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 Timeline

• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Study Start: 2012-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-17
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 401

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prolapse Efficacy - POP-Q	annually, upto 5 years	Prolapse Endpoints: • POP-Q measurement
Urinary Incontinence Endpoints	annually upto 5 years	Urinary Incontinence Endpoints: * Cough stress test; * 1 hour pad weight test; * Urodynamics

Trial Locations

Locations (19)

Atlanta Medical Research Institute; 🇺🇸 Alpharetta, Georgia, United States

Morristown Memorial Hospital; 🇺🇸 Morristown, New Jersey, United States

Womancare; 🇺🇸 Winston-Salem, North Carolina, United States

Seven Hills Women's Health Centers; 🇺🇸 Cinncinatti, Ohio, United States

The Female Pelvic Health Center; 🇺🇸 Newtown, Pennsylvania, United States

Female Pelvic Medicine Institute of Virginia; 🇺🇸 Richmond, Virginia, United States

The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre; 🇨🇦 Ottawa, Ontario, Canada

Windsor Research Office; 🇨🇦 Windsor, Ontario, Canada

CMC Beau Soleil; 🇫🇷 Montpellier, France

Hôpital BICÊTRE; 🇫🇷 Paris, France

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