Female Stress IncontinenceCAPTURENCT01673360
Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
An observational study of Female Stress Incontinence and Pelvic Organ Prolapse, run by ASTORA Women's Health at 19 sites in 8 countries.
Trial summary
To monitor post-market performance through evaluation of short and long-term performance via: Efficacy Safety Patient reported outcomes Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Incontinence, Pelvic Organ Prolapse
- What is being tested?
- Elevate PC, Mini Arc Pro and RetroArc
- Type of treatment
- Medical device
- How many people
- 401 participants
- Where
- 19 sitesin 8 countries
- Study dates
- Sep 2012to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.
Who may be able to join
- Patients must meet all of the following criteria to be considered for inclusion in the registry.
- Have a signed Informed Consent Form
- Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
- Is a female at least 18 years of age
- Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
- Is able and willing to participate in the registry
Who cannot join
- Patients will be excluded from the registry if any one of the following criteria is met.
- Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU
Trial locations and contacts
19 sites in 8 countries.
19 sites in 8 countries
United States6 sites
Atlanta Medical Research Institute
Alpharetta, Georgia, 30005
Seven Hills Women's Health Centers
Cinncinatti, Ohio, 45242
Morristown Memorial Hospital
Morristown, New Jersey, 07962
The Female Pelvic Health Center
Newtown, Pennsylvania, 18940
Female Pelvic Medicine Institute of Virginia
Richmond, Virginia, 23235
Womancare
Winston-Salem, North Carolina, 27103
Spain3 sites
Hospital Clínico y Provincial de Barcelona
Barcelona
Hospital Beata María Ana de Jesus
Madrid
Hospital Rio Hortega
Valladolid
Canada2 sites
The Ottawa Hospital - Shirley E. Greenberg Women's Health Centre
Ottawa, Ontario, K1H 7W9
Windsor Research Office
Windsor, Ontario, N8W 5L7
Germany2 sites
German Pelvic Floor Center, St. Hedwig Hospital
Berlin, 11 10115
Waldburg-Zeil Kliniken Klinik Tettnang
Tettnang, 16 88069
United Kingdom2 sites
Royal Bolton Hospital
Bolton
Glasgow - Southern General Hospital
Glasgow
About this study
To monitor post-market performance through evaluation of short and long-term performance via:
- Efficacy
- Safety
- Patient reported outcomes
Read the detailed description
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
- Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
- Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
- Collect concomitant procedural data related to the pelvic floor area
- Conditions
- Female Stress Incontinence, Pelvic Organ Prolapse
- Being tested
- Elevate PC, Mini Arc Pro, RetroArc
- Keywords
- vaginal repair, urinary slings, POP, SUI, prolapse, incontinence
- Medical subject headings
- Pelvic Organ Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elevate PCDevice
List of AMS prolapse products
Mini Arc ProDevice
List of AMS Urinary Incontinence devices
RetroArcDevice
List of AMS Urinary Incontinence devices
| Study group | Role | What they receive |
|---|---|---|
| Elevate PC | Subjects implanted with Elevate PC Receives: Device: Elevate PC | |
| Mini Arc Pro | Subjects implanted with Mini Arc Pro Receives: Device: Mini Arc Pro | |
| RetroArc | Subjects implanted with RetroArc Receives: Device: RetroArc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolapse Efficacy - POP-Q
Prolapse Endpoints:
- POP-Q measurement
Measured: annually, upto 5 years
Urinary Incontinence Endpoints
Urinary Incontinence Endpoints:
- Cough stress test
- 1 hour pad weight test
- Urodynamics
Measured: annually upto 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Sponsor is winding down business operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress IncontinenceStudies 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
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- ASTORA Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673360
- Sponsor's protocol ID
- PR1102
- Acronym
- CAPTURE
- Status last verified
- Jun 2016
- First submitted
- 23 Aug 2012
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Long Term Patient Outcomes Data Following Implantation of AMS Surgical Devices
- ClinicalTrials.gov ID
- NCT01673360
- Acronym / sponsor ID
- CAPTURE / PR1102
- Conditions
- Female Stress Incontinence, Pelvic Organ Prolapse
- Keywords
- vaginal repair, urinary slings, POP, SUI, prolapse, incontinence
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor is winding down business operations
- Enrolment
- 401 participants (actual)
- Lead sponsor
- ASTORA Women's HealthIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To monitor post-market performance through evaluation of short and long-term performance via:
- Efficacy
- Safety
- Patient reported outcomes
Detailed description
As this is a post-market registry on market approved devices, there will be no formal hypothesis testing. However, points of evaluation will include:
- Characterize the efficacy of the AMS market approved female pelvic health products using standard of care outcome measures and validated quality of life questionnaires
- Characterize the type, severity, and rate of adverse events related to each AMS market approved female pelvic health product
- Collect concomitant procedural data related to the pelvic floor area
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elevate PC | – | Device: Elevate PCSubjects implanted with Elevate PC |
| Mini Arc Pro | – | Device: Mini Arc ProSubjects implanted with Mini Arc Pro |
| RetroArc | – | Device: RetroArcSubjects implanted with RetroArc |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients planned to receive at least one (1) target AMS market approved female pelvic health product will be considered for inclusion in the registry.
Key inclusion criteria (6 listed)
- Patients must meet all of the following criteria to be considered for inclusion in the registry.
Key exclusion criteria (2 listed)
- Patients will be excluded from the registry if any one of the following criteria is met.
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 |
|---|---|---|
| Elevate PCList of AMS prolapse products | Device | Elevate PC |
| Mini Arc ProList of AMS Urinary Incontinence devices | Device | Mini Arc Pro |
| RetroArcList of AMS Urinary Incontinence devices | Device | RetroArc |
Primary outcome
Prolapse Efficacy - POP-Q
Time frame: annually, upto 5 years
Prolapse Endpoints: • POP-Q measurement
Urinary Incontinence Endpoints
Time frame: annually upto 5 years
Urinary Incontinence Endpoints: * Cough stress test * 1 hour pad weight test * Urodynamics
Results and safety
The study was stopped early (reason given: Sponsor is winding down business operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Stress Incontinence and Pelvic Organ Prolapse, run by ASTORA Women's Health at 19 sites in 8 countries.
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 6 inclusion and 2 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: stopped early, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Spain, Canada, France, Germany and 3 more countries. 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?
The study was stopped early (reason given: Sponsor is winding down business operations). Results are not available in the source record.
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?
Prolapse Efficacy - POP-Q (time frame: annually, upto 5 years). The study lists 2 primary outcomes in all. 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 17 Jun 2016.