Stress Urinary IncontinenceNCT00688181
The Prefyx PPS™ System eRegistry
An observational study of Stress Urinary Incontinence, run by Boston Scientific Corporation at 5 sites in United States.
Trial summary
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- The Prefyx PPS™ Pre-pubic Sling System
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2006to Apr 2009
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) should be eligible for enrollment in the PPS eRegistry. However, any patient meeting any of the contraindications should NOT be included as noted in the Directions For Use. Minors are excluded from the registry per contraindications in which mesh implants are contraindicated in 'patients with the potential for future growth'.
Who may be able to join
- Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
Who cannot join
- Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
- Any patients with soft tissue pathology into which the implant is to be placed.
- Patients with any pathology which would compromise implant placement.
- Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Urology Specialists of Atlanta, LLC /Northside Hospital
Atlanta, Georgia, 30328
South Florida Urology Center
Pembroke Pines, Florida, 33028
HillCrest Medical Center
Tulsa, Oklahoma
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida, 33401
Affiliates in Urology
Westland, Michigan, 48186
About this study
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Read the detailed description
Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.
- Conditions
- Stress Urinary Incontinence
- Being tested
- The Prefyx PPS™ Pre-pubic Sling System
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Prefyx PPS™ Pre-pubic Sling SystemDevice
device designed to treat female stress urinary incontinence (SUI).
| Study group | Role | What they receive |
|---|---|---|
| Subjects treated with the Prefyx PPS System | All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use. Receives: Device: The Prefyx PPS™ Pre-pubic Sling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Measured: 3 months
Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Measured: 12 months
Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression
Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied).
Measured: 12 months
Number of Participants With Adverse Events
Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startDec 2006
- Primary completionNov 2008
- Study completionApr 2009
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Walsh, M.D., Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688181
- Sponsor's protocol ID
- U8043
- Status last verified
- Feb 2021
- First submitted
- 28 May 2008
- Last updated
- 1 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prefyx PPS™ System eRegistry
- ClinicalTrials.gov ID
- NCT00688181
- Acronym / sponsor ID
- U8043
- Conditions
- Stress Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Detailed description
Registry to gather information about the long term use of the Prefyx PPS System which utilizes a pre-pubic surgical approach (device is to be placed in front of the pubic bone) for the treatment of SUI. No additional procedures are required beyond the physician's standard of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects treated with the Prefyx PPS System | – | Device: The Prefyx PPS™ Pre-pubic Sling SystemAll patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) should be eligible for enrollment in the PPS eRegistry. However, any patient meeting any of the contraindications should NOT be included as noted in the Directions For Use. Minors are excluded from the registry per contraindications in which mesh implants are contraindicated in 'patients with the potential for future growth'.
Key inclusion criteria (1 listed)
- Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
Key exclusion criteria (4 listed)
- Pregnant patients, patients with the potential for future growth or patients that are considering future pregnancies.
- Any patients with soft tissue pathology into which the implant is to be placed.
- Patients with any pathology which would compromise implant placement.
- Patients with any pathology, such as blood supply limitations or infections that would compromise healing.
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 |
|---|---|---|
| The Prefyx PPS™ Pre-pubic Sling Systemdevice designed to treat female stress urinary incontinence (SUI). | Device | Subjects treated with the Prefyx PPS System |
Primary outcome
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up
Time frame: 3 months
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up
Time frame: 12 months
Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression
Time frame: 12 months
Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied).
Number of Participants With Adverse Events
Time frame: 12 months
Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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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.
Robert Walsh, M.D. study director
Boston Scientific Corporation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence, run by Boston Scientific Corporation at 5 sites 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 1 inclusion and 4 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 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 Mar 2021). 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?
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up (time frame: 3 months). The study lists 4 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 1 Mar 2021.