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

NCT01673360 | Terminated

• 1 other identifier: PR1102
• Study Type: observational
• Target: 401
• Locations: 8 countries
• Sites: 19

Brief Summary

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

• Efficacy
• Safety
• Patient reported outcomes

Conditions

Female Stress Incontinence; Pelvic Organ Prolapse

Keywords

vaginal repair; urinary slings; POP; SUI; prolapse; incontinence

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Elevate PC

Subjects implanted with Elevate PC

Device: Elevate PC

Mini Arc Pro

Subjects implanted with Mini Arc Pro

Device: Mini Arc Pro

RetroArc

Subjects implanted with RetroArc

Device: RetroArc

Interventions

Elevate PC DEVICE

List of AMS prolapse products

Elevate PC

Mini Arc Pro DEVICE

List of AMS Urinary Incontinence devices

Mini Arc Pro

RetroArc DEVICE

List of AMS Urinary Incontinence devices

RetroArc

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ASTORA Women's Health: lead

Study Sites (19)

Atlanta Medical Research Institute

Alpharetta, Georgia, 30005, United States

Location

Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Womancare

Winston-Salem, North Carolina, 27103, United States

Location

Seven Hills Women's Health Centers

Cinncinatti, Ohio, 45242, United States

Location

The Female Pelvic Health Center

Newtown, Pennsylvania, 18940, United States

Location

Female Pelvic Medicine Institute of Virginia

Richmond, Virginia, 23235, United States

Location

The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre

Ottawa, Ontario, K1H 7W9, Canada

Location

Windsor Research Office

Windsor, Ontario, N8W 5L7, Canada

Location

CMC Beau Soleil

Montpellier, 34070, France

Location

Hôpital BICÊTRE

Paris, France

Location

German Pelvic Floor Center, St. Hedwig Hospital

Berlin, 11 10115, Germany

Location

Waldburg-Zeil Kliniken Klinik Tettnang

Tettnang, 16 88069, Germany

Location

University Medical Centre Maribor

Maribor, Slovenia

Location

Pretoria Urology Hospital

Pretoria, South Africa

Location

Hospital Clínico y Provincial de Barcelona

Barcelona, Spain

Location

Hospital Beata María Ana de Jesus

Madrid, Spain

Location

Hospital Rio Hortega

Valladolid, Spain

Location

Royal Bolton Hospital

Bolton, United Kingdom

Location

Glasgow - Southern General Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: August 28, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: June 17, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1); CA (2); GB (2); DE (2); SL (1); FR (2); US (6); ES (3)