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

Terminated

• Conditions: Pelvic Organ Prolapse; Female Stress Incontinence
• Interventions: Device: RetroArc; Device: Elevate PC; Device: Mini Arc Pro

• 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

Arm && Interventions

Group	Intervention	Description
RetroArc	RetroArc	Subjects implanted with RetroArc
Elevate PC	Elevate PC	Subjects implanted with Elevate PC
Mini Arc Pro	Mini Arc Pro	Subjects implanted with Mini Arc Pro

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)

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

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

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

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

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

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

CMC Beau Soleil; 🇫🇷 Montpellier, France

Windsor Research Office; 🇨🇦 Windsor, Ontario, Canada

Hospital Clínico y Provincial de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Beata María Ana de Jesus; 🇪🇸 Madrid, Spain

German Pelvic Floor Center, St. Hedwig Hospital; 🇩🇪 Berlin, Germany

Hôpital BICÊTRE; 🇫🇷 Paris, France

Waldburg-Zeil Kliniken Klinik Tettnang; 🇩🇪 Tettnang, Germany

University Medical Centre Maribor; 🇸🇮 Maribor, Slovenia

Royal Bolton Hospital; 🇬🇧 Bolton, United Kingdom

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

Pretoria Urology Hospital; 🇿🇦 Pretoria, South Africa

Hospital Rio Hortega; 🇪🇸 Valladolid, Spain

Glasgow - Southern General Hospital; 🇬🇧 Glasgow, United Kingdom