An observational study in Vaginal Prolapse, sponsored by ASTORA Women's Health. Completed at 1 site in United States. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-08-11.
Sponsored by ASTORA Women's Health · Observational
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.
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).
111 studies on the registry are indexed under Uterine Prolapse; 20 are open to participants now.
This study's enrollment of 1,543 is above the median of 132 across 28 observational studies indexed under Uterine Prolapse.
Browse Uterine Prolapse studies →ASTORA Women's Health is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female subjects greater than or equal to 21 years of age with genital prolapse who undergo surgical reconstruction of the pelvic floor using an AMS Prolapse Repair device.
Exclusion Criteria:
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
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
Also known as: Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
Time frame: up to 2-years post-implant
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
The first patient was registered in September 2006, The last patient data were entered in May 2010.
| Milestone | 1 - Any AMS Prolapse Product |
|---|---|
| Started | 1590 |
| Completed | 1543 |
| Not completed | 47 |
| Withdrew: Protocol violation | 47 |
| participants | 1 - Any AMS Prolapse Product |
|---|---|
| Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device | 194 |
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.
| percentage of participants | 1 - Any AMS Prolapse Product |
|---|---|
| Prolapse Efficacy Success Rate | 81.6 (77.0 to 85.6) |
Collected over 2 years. Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1 - Any AMS Prolapse Product | — | 71/1,543 (4.6%) | 138/1,543 (8.9%) |
| Event | 1 - Any AMS Prolapse Product |
|---|---|
| ExtrusionGeneral disorders | 24/1543 |
| ProlapseReproductive system and breast disorders | 14/1543 |
| IncontinenceRenal and urinary disorders | 6/1543 |
| Perforation - bladderInjury, poisoning and procedural complications | 5/1543 |
| Pain - excluding dyspareuniaGeneral disorders | 3/1543 |
| Wound separation <3 months post-opGeneral disorders | 3/1543 |
| ConstipationGastrointestinal disorders | 2/1543 |
| Dehiscence at vaginal suture line before healing occursSurgical and medical procedures | 2/1543 |
| Granuloma formationSkin and subcutaneous tissue disorders | 2/1543 |
| Other GenitourinaryGeneral disorders | 2/1543 |
| Event | 1 - Any AMS Prolapse Product |
|---|---|
| prolapseReproductive system and breast disorders | 40/1543 |
| extrusionGeneral disorders | 30/1543 |
| other events below thresholdSkin and subcutaneous tissue disorders | 28/1543 |
| pain (excluding dyspareunia)General disorders | 15/1543 |
| infectionInfections and infestations | 13/1543 |
| incontinenceRenal and urinary disorders | 12/1543 |
| granuloma formationSkin and subcutaneous tissue disorders | 11/1543 |
| hematomaSurgical and medical procedures | 10/1543 |
| Age, Continuous(participants) | 1 - Any AMS Prolapse Product |
|---|---|
| Age <89 years | 62 ± 12 |
| Sex: Female, Male(Participants) | 1 - Any AMS Prolapse Product |
|---|---|
| Female | 1590 |
| Male | 0 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ASTORA Women's Health