N/A
N=1,590
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
Vaginal Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00388947 ↗Enrolled (actual)
1,590
Serious AEs
4.6%
Results posted
Nov 2012
Primary outcome: Primary: Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device — 194 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- AMS Prolapse Product (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- ASTORA Women's Health
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device |
194 | — |
| SECONDARY Prolapse Efficacy Success Rate |
81.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00388947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.