Vaginal ProlapsePOWER1012NCT00388947
Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products
An observational study of Vaginal Prolapse, run by ASTORA Women's Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Vaginal Prolapse
- What is being tested?
- AMS Prolapse Product
- Type of treatment
- Medical device
- How many people
- 1,543 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to May 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.
Trial locations and contacts
1 site in 1 country.
United States1 site
Samuel Zylstra, MD
Whitinsville, Massachusetts, 01588
About this study
Official title: The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse
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.
Read the 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).
- Conditions
- Vaginal Prolapse
- Being tested
- AMS Prolapse Product
- Keywords
- vaginal prolapse, cystocele, rectocele, enterocele, apical prolapse, vaginal vault prolapse
- Medical subject headings
- Uterine Prolapse, Cystocele, Rectocele, Hernia, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMS Prolapse ProductDevice
Also called Apogee, Straight-In, Perigee, Elevate anterior, Elevate Posterior
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: AMS Prolapse Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
Measured: up to 2-years post-implant
Secondary outcomes (1)
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaginal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASTORA Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Zylstra, MD, Principal investigator, Whitinsville Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388947
- Sponsor's protocol ID
- 1012
- Acronym
- POWER1012
- Status last verified
- Jul 2016
- First submitted
- 16 Oct 2006
- Last updated
- 11 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prolapse Registry: An Observational Collection of Short- and Long-Term Patient Outcomes Following Use of AMS Surgical Devices for the Repair of Female Genital Prolapse
- ClinicalTrials.gov ID
- NCT00388947
- Acronym / sponsor ID
- POWER1012 / 1012
- Conditions
- Vaginal Prolapse
- Keywords
- vaginal prolapse, cystocele, rectocele, enterocele, apical prolapse, vaginal vault prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,543 participants (actual)
- Lead sponsor
- ASTORA Women's HealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Oct 2006 (estimated)
- Results
- Posted 20 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: AMS Prolapse ProductAMS 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) |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMS Prolapse ProductAlso: Apogee, Straight-In, Perigee, Elevate anterior, Elevate PosteriorAMS 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 | 1 |
Primary outcome
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device
Time frame: up to 2-years post-implant
1 secondary outcome
Prolapse Efficacy Success Rate
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vaginal Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Recruiting
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
Prolapse Pelvic, Hysterectomy
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
RecruitingPhase 3
Vaginal Estrogen for Improvement of Outcomes Following Pelvic Organ Prolapse Surgery
Pelvic Organ Prolapse (POP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Zylstra, MD principal investigator
Whitinsville Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Prolapse, run by ASTORA Women's Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device (time frame: up to 2-years post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2016.