Vaginal Prolapse
Conditions
Keywords
vaginal prolapse, cystocele, rectocele, enterocele, apical prolapse, vaginal vault prolapse
Brief summary
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
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).
Interventions
DEVICEAMS 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
Sponsors
ASTORA Women's Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device | up to 2-years post-implant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prolapse Efficacy Success Rate | 24 months | 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. |
Countries
United States
Participant flow
Recruitment details
The first patient was registered in September 2006, The last patient data were entered in May 2010.
Pre-assignment details
Patients had to met all of the inclusion criteria and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| 1 - Any AMS Prolapse Product at least one AMS prolapse product was used | 1,590 |
| Total | 1,590 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 47 |
Baseline characteristics
| Characteristic | 1 - Any AMS Prolapse Product |
|---|---|
| Age, Continuous Age <89 years | 62 participants STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 1590 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 138 / 1,543 |
| serious Total, serious adverse events | 71 / 1,543 |
Outcome results
Primary
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
Time frame: up to 2-years post-implant
Population: All patients that met the inclusion/exclusion criteria.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Any AMS Prolapse Product | Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device | 194 participants |
Secondary
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.
Time frame: 24 months
Population: Patients returning for a visit between 19-24 months post-procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Any AMS Prolapse Product | Prolapse Efficacy Success Rate | 81.6 percentage of participants |