Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMS Prolapse Product | Device | 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 |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samuel Zylstra, MD | Whitinsville Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samuel Zylstra, MD | Whitinsville | Massachusetts | 01588 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients had to met all of the inclusion criteria and none of the exclusion criteria.
The first patient was registered in September 2006, The last patient data were entered in May 2010.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 1 - Any AMS Prolapse Product | at least one AMS prolapse product was used |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 1 - Any AMS Prolapse Product | at least one AMS prolapse product was used |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patients >89 years old were excluded because protected health information was not collected in this study. Mean age excludes patients >89 years old. Two patients were >89 years old. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device | All patients that met the inclusion/exclusion criteria. | Posted | Number | participants | up to 2-years post-implant |
|
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1 - Any AMS Prolapse Product | at least one AMS prolapse product was used |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adhesion | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| extrusion | General disorders | Non-systematic Assessment | mesh exposure through vaginal mucosa |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Samuel Zylstra | Whitinsville Medical Center | 508-243-6260 | samuelzylstra@milreg.org |
Not provided
| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| D052858 | Cystocele |
| D020047 | Rectocele |
| D006547 | Hernia |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Mean |
| Standard Deviation |
| participants |
|
| Sex: Female, Male | Count of Participants | 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. | Patients returning for a visit between 19-24 months post-procedure. | Posted | Number | 95% Confidence Interval | percentage of participants | 24 months |
|
|
|
| 71 |
| 1,543 |
| 138 |
| 1,543 |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dehiscence at vaginal suture line before healing occurs | Surgical and medical procedures | Non-systematic Assessment |
|
| Extrusion | General disorders | Non-systematic Assessment |
|
| Granuloma formation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | Non-systematic Assessment | includes denovo and recurrent incontinence |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Other Genitourinary | General disorders | Non-systematic Assessment | 1)Coumadin medicated patient received too much anticoagulation therapy resulting in bleeding 2)small separation of anterior mesh from vaginal mucosa |
|
| Pain - dyspareunia | General disorders | Non-systematic Assessment |
|
| Pain - excluding dyspareunia | General disorders | Non-systematic Assessment |
|
| Perforation - bladder | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Prolapse | Reproductive system and breast disorders | Non-systematic Assessment | includes denovo and recurrent |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary urge, frequency, or hesistancy | Renal and urinary disorders | Non-systematic Assessment |
|
| Wound separation <3 months post-op | General disorders | Non-systematic Assessment | Wound separation events less than 3 months post-procedure including mesh exposure events |
|
|
| granuloma formation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| hematoma | Surgical and medical procedures | Non-systematic Assessment |
|
| incontinence | Renal and urinary disorders | Non-systematic Assessment | Includes both denovo and worsening incontinence |
|
| infection | Infections and infestations | Non-systematic Assessment |
|
| other events below threshold | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Incongruous events that are individually below the threshold |
|
| pain (excluding dyspareunia) | General disorders | Non-systematic Assessment |
|
| prolapse | Reproductive system and breast disorders | Non-systematic Assessment | includes denovo and recurrent prolapse |
|
AMS (sponsor) is the sole owner of the conglomerate data inputted into the POWER database and has the right to publish such data at its sole discretion. Registry Physician will provide AMS with a copy of any data, finding, result, article, abstract, manuscripts, presentation, or other information intended for publication, at least thirty (30) days prior to submission of same for publication.
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |