Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

Study Overview
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Brief Summary
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This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Detailed Description
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The Prolapse Registry was an observational study of patients who were implanted with AMS devices for the surgical repair of female pelvic prolapse. The registry followed patients post-operatively for up to 2 years and collected demographic, clinical, surgical, safety, and patient outcomes data. The registry was a web-based system in which surgeons entered patient information with regard to their prolapse surgery. All information entered was de-identified (no names, no date of birth, no date of surgery, etc).

Official Title
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The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse

Conditions
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Vaginal Prolapse

Intervention / Treatment
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* Device: AMS Prolapse Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female at least 21 years old Has pelvic organ prolapse requiring surgical repair Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse Exclusion Criteria: Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>AMS Prolapse Product (AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family) | Device: AMS Prolapse Product<br>* AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Mesh implant for posterior wall pelvic organ prolapse AMS Straight-In™ with IntePro (Synthetic) Mesh implant for vaginal vault pelvic organ prolapse AMS Perigee™ with IntePro Mesh implant for anterior wall pelvic organ prolapse AMS Perigee™ with IntePro Mesh coated with PC AMS Elevate® Prolapse Repair System Family<br>* Other names: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device |  | up to 2-years post-implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse Efficacy Success Rate | Success was defined as either (1) Baden-Walker grade 0 or 1 or (2) (Pelvic Organ Prolapse Quantification System) POP-Q stage 0 or 1. If a site reported both measurements, then the POP-Q score was used. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal prolapse, cystocele, rectocele, enterocele, apical prolapse, vaginal vault prolapse