The Prefyx PPS™ System eRegistry
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Boston Scientific Corporation.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Boston Scientific Corporation
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00688181
First received: May 28, 2008
Last updated: March 30, 2009
Last verified: March 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Stress Urinary Incontinence |
Device: The Prefyx PPS™ Pre-pubic Sling System |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Prefyx PPS™ System eRegistry |
Resource links provided by NLM:
Further study details as provided by Boston Scientific Corporation:
Primary Outcome Measures:
- The percentage of subjects who report substantial improvement and consider the surgery successful, as measured by the Patient's Global Impression [ Time Frame: 12, 24 and 36 months post operatively ] [ Designated as safety issue: No ]
- Evaluation of reported Adverse Events [ Time Frame: 12 months post operatively ] [ Designated as safety issue: No ]
- The percentage of subjects who remain continent or improved following treatment at timed intervals [ Time Frame: 3 and 12 months post-operative ] [ Designated as safety issue: No ]
| Enrollment: | 44 |
| Study Start Date: | December 2006 |
| Estimated Study Completion Date: | April 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cohort 1
All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use.
|
Device: The Prefyx PPS™ Pre-pubic Sling System
device designed to treat female stress urinary incontinence (SUI).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| 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'.
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00688181
Locations
| United States, Florida | |
| South Florida Urology Center | |
| Pembroke Pines, Florida, United States, 33028 | |
| OB/GYN Specialists of the Palm Beaches | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Georgia | |
| Urology Specialists of Atlanta, LLC /Northside Hospital | |
| Atlanta, Georgia, United States, 30328 | |
| United States, Michigan | |
| Affiliates in Urology | |
| Westland, Michigan, United States, 48186 | |
| United States, Oklahoma | |
| HillCrest Medical Center | |
| Tulsa, Oklahoma, United States | |
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
| Study Director: | Robert Walsh, M.D. | Boston Scientific Corporation |
More Information
No publications provided
| Responsible Party: | Erin Leckrone, Boston Scientific |
| ClinicalTrials.gov Identifier: | NCT00688181 History of Changes |
| Other Study ID Numbers: | U8043 |
| Study First Received: | May 28, 2008 |
| Last Updated: | March 30, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Urinary Incontinence Urinary Incontinence, Stress Urination Disorders |
Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013