The Prefyx PPS™ System eRegistry
February 25, 2021 updated by: Boston Scientific Corporation
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
44
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Pembroke Pines, Florida, United States, 33028
- South Florida Urology Center
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West Palm Beach, Florida, United States, 33401
- OB/GYN Specialists of the Palm Beaches
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Georgia
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Atlanta, Georgia, United States, 30328
- Urology Specialists of Atlanta, LLC /Northside Hospital
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Michigan
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Westland, Michigan, United States, 48186
- Affiliates in Urology
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Oklahoma
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Tulsa, Oklahoma, United States
- Hillcrest Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
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'.
Description
Inclusion Criteria:
- Patients presenting for treatment of female Urinary Stress Incontinence (SUI)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
device designed to treat female stress urinary incontinence (SUI).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
|
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
|
12 months
|
|
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).
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12 months
|
|
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.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Walsh, M.D., Boston Scientific Corporation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2006
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
May 28, 2008
First Submitted That Met QC Criteria
May 28, 2008
First Posted (Estimate)
June 2, 2008
Study Record Updates
Last Update Posted (Actual)
March 1, 2021
Last Update Submitted That Met QC Criteria
February 25, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U8043
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.