Trial Outcomes & Findings for Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products (NCT NCT00388947)
NCT ID: NCT00388947
Last Updated: 2016-08-11
Results Overview
Recruitment status
COMPLETED
Target enrollment
1543 participants
Primary outcome timeframe
up to 2-years post-implant
Results posted on
2016-08-11
Participant Flow
The first patient was registered in September 2006, The last patient data were entered in May 2010.
Patients had to met all of the inclusion criteria and none of the exclusion criteria.
Participant milestones
| Measure |
1 - Any AMS Prolapse Product
at least one AMS prolapse product was used
|
|---|---|
|
Overall Study
STARTED
|
1590
|
|
Overall Study
COMPLETED
|
1543
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
1 - Any AMS Prolapse Product
at least one AMS prolapse product was used
|
|---|---|
|
Overall Study
Protocol Violation
|
47
|
Baseline Characteristics
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
Baseline characteristics by cohort
| Measure |
1 - Any AMS Prolapse Product
n=1590 Participants
at least one AMS prolapse product was used
|
|---|---|
|
Age, Continuous
Age <89 years
|
62 participants
STANDARD_DEVIATION 12 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1590 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: up to 2-years post-implantPopulation: All patients that met the inclusion/exclusion criteria.
Outcome measures
| Measure |
1 - Any AMS Prolapse Product
n=1543 Participants
at least one AMS prolapse product was used
|
|---|---|
|
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
|
194 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Patients returning for a visit between 19-24 months post-procedure.
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.
Outcome measures
| Measure |
1 - Any AMS Prolapse Product
n=332 Participants
at least one AMS prolapse product was used
|
|---|---|
|
Prolapse Efficacy Success Rate
|
81.6 percentage of participants
Interval 77.0 to 85.6
|
Adverse Events
1 - Any AMS Prolapse Product
Serious events: 71 serious events
Other events: 138 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1 - Any AMS Prolapse Product
n=1543 participants at risk
at least one AMS prolapse product was used
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Adhesion
|
0.06%
1/1543 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
Surgical and medical procedures
Dehiscence at vaginal suture line before healing occurs
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
General disorders
Extrusion
|
1.6%
24/1543 • Number of events 26 • 2 years
|
|
Skin and subcutaneous tissue disorders
Granuloma formation
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Hematoma
|
0.06%
1/1543 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Incontinence
|
0.39%
6/1543 • Number of events 6 • 2 years
|
|
Infections and infestations
Infection
|
0.06%
1/1543 • Number of events 1 • 2 years
|
|
General disorders
Other Genitourinary
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
General disorders
Pain - dyspareunia
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
General disorders
Pain - excluding dyspareunia
|
0.19%
3/1543 • Number of events 3 • 2 years
|
|
Injury, poisoning and procedural complications
Perforation - bladder
|
0.32%
5/1543 • Number of events 5 • 2 years
|
|
Reproductive system and breast disorders
Prolapse
|
0.91%
14/1543 • Number of events 14 • 2 years
|
|
Renal and urinary disorders
Urinary retention
|
0.06%
1/1543 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Urinary urge, frequency, or hesistancy
|
0.13%
2/1543 • Number of events 2 • 2 years
|
|
General disorders
Wound separation <3 months post-op
|
0.19%
3/1543 • Number of events 3 • 2 years
|
Other adverse events
| Measure |
1 - Any AMS Prolapse Product
n=1543 participants at risk
at least one AMS prolapse product was used
|
|---|---|
|
General disorders
extrusion
|
1.9%
30/1543 • Number of events 32 • 2 years
|
|
Skin and subcutaneous tissue disorders
granuloma formation
|
0.71%
11/1543 • Number of events 11 • 2 years
|
|
Surgical and medical procedures
hematoma
|
0.65%
10/1543 • Number of events 10 • 2 years
|
|
Renal and urinary disorders
incontinence
|
0.78%
12/1543 • Number of events 12 • 2 years
|
|
Infections and infestations
infection
|
0.84%
13/1543 • Number of events 14 • 2 years
|
|
Skin and subcutaneous tissue disorders
other events below threshold
|
1.8%
28/1543 • Number of events 28 • 2 years
|
|
General disorders
pain (excluding dyspareunia)
|
0.97%
15/1543 • Number of events 15 • 2 years
|
|
Reproductive system and breast disorders
prolapse
|
2.6%
40/1543 • Number of events 41 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER