Female Stress Incontinence, Pelvic Organ Prolapse
Conditions
Keywords
vaginal repair, urinary slings, POP, SUI, prolapse, incontinence
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
Interventions
DEVICEElevate PC
List of AMS prolapse products
DEVICEMini Arc Pro
List of AMS Urinary Incontinence devices
DEVICERetroArc
List of AMS Urinary Incontinence devices
Sponsors
ASTORA Women's Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada, France, Germany, Slovenia, South Africa, Spain, United Kingdom, United States
Outcome results
None listed