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

Pelvic Organ Prolapse Clinical Trial

— CAPTURE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01673360
• Other study ID #: PR1102
• Status: Terminated
• Phase: N/A
• First received: August 23, 2012
• Last updated: June 16, 2016
• Start date: September 2012
• Est. completion date: December 2021

Study information

• Verified date: June 2016
• Source: ASTORA Women’s Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSpain: Ethics CommitteeUnited Kingdom: National Health ServiceSlovenia: Ethics CommitteeFrance: Conseil National de l'Ordre des MédecinsFrance: French Data Protection AuthorityBelgium: Ethics CommitteeSouth Africa: Human Research Ethics CommitteeCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

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

• Efficacy

• Safety

• Patient reported outcomes

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 401
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Female Stress Incontinence
• Pelvic Organ Prolapse
• Prolapse
• Urinary Incontinence, Stress

Intervention

Device:
• Elevate PC
List of AMS prolapse products
• Mini Arc Pro
List of AMS Urinary Incontinence devices
• RetroArc
List of AMS Urinary Incontinence devices

Locations

Country	Name	City	State
Canada	The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre	Ottawa	Ontario
Canada	Windsor Research Office	Windsor	Ontario
France	CMC Beau Soleil	Montpellier
France	Hôpital BICÊTRE	Paris
Germany	German Pelvic Floor Center, St. Hedwig Hospital	Berlin
Germany	Waldburg-Zeil Kliniken Klinik Tettnang	Tettnang
Slovenia	University Medical Centre Maribor	Maribor
South Africa	Pretoria Urology Hospital	Pretoria
Spain	Hospital Clínico y Provincial de Barcelona	Barcelona
Spain	Hospital Beata María Ana de Jesus	Madrid
Spain	Hospital Rio Hortega	Valladolid
United Kingdom	Royal Bolton Hospital	Bolton
United Kingdom	Glasgow - Southern General Hospital	Glasgow
United States	Atlanta Medical Research Institute	Alpharetta	Georgia
United States	Seven Hills Women's Health Centers	Cinncinatti	Ohio
United States	Morristown Memorial Hospital	Morristown	New Jersey
United States	The Female Pelvic Health Center	Newtown	Pennsylvania
United States	Female Pelvic Medicine Institute of Virginia	Richmond	Virginia
United States	Womancare	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ASTORA Women’s Health

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Slovenia,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolapse Efficacy - POP-Q	Prolapse Endpoints: • POP-Q measurement	annually, upto 5 years	No
Primary	Urinary Incontinence Endpoints	Urinary Incontinence Endpoints: Cough stress test; 1 hour pad weight test; Urodynamics	annually upto 5 years	No