Clinical trial NCT01673360: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Official title: Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Female Stress Incontinence
Pelvic Organ Prolapse
Keywords: vaginal repair
urinary slings
POP
SUI
prolapse
incontinence
Lead sponsor: ASTORA Women's Health
Sponsor class: INDUSTRY
First posted: 2012-08-28
Enrollment: 401
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Prolapse Efficacy - POP-Q
timeFrame: annually, upto 5 years
measure: Urinary Incontinence Endpoints
timeFrame: annually upto 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute
state: Georgia
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Winston-Salem
country: United States
facility: Womancare
state: North Carolina
city: Cinncinatti
country: United States
facility: Seven Hills Women's Health Centers
state: Ohio
city: Newtown
country: United States
facility: The Female Pelvic Health Center
state: Pennsylvania
city: Richmond
country: United States
facility: Female Pelvic Medicine Institute of Virginia
state: Virginia
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Research Office
state: Ontario
city: Montpellier
country: France
facility: CMC Beau Soleil
city: Paris
country: France
facility: Hôpital BICÊTRE
city: Berlin
country: Germany
facility: German Pelvic Floor Center, St. Hedwig Hospital
city: Tettnang
country: Germany
facility: Waldburg-Zeil Kliniken Klinik Tettnang
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
city: Pretoria
country: South Africa
facility: Pretoria Urology Hospital
city: Barcelona
country: Spain
facility: Hospital Clínico y Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Beata María Ana de Jesus
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Bolton
country: United Kingdom
facility: Royal Bolton Hospital
city: Glasgow
country: United Kingdom
facility: Glasgow - Southern General Hospital
Study officials:
References: