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The Prefyx PPS™ System eRegistry

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ClinicalTrials.gov Identifier: NCT00688181
Recruitment Status : Unknown
Verified March 2009 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
First Posted : June 2, 2008
Last Update Posted : March 31, 2009
Sponsor:
Information provided by:
Boston Scientific Corporation

Brief Summary:
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 or disease Intervention/treatment
Stress Urinary Incontinence Device: The Prefyx PPS™ Pre-pubic Sling System

Study Type : Observational
Actual Enrollment : 44 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Prefyx PPS™ System eRegistry
Study Start Date : December 2006
Actual Primary Completion Date : November 2008
Estimated Study Completion Date : April 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).




Primary Outcome Measures :
  1. 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 ]
  2. Evaluation of reported Adverse Events [ Time Frame: 12 months post operatively ]
  3. The percentage of subjects who remain continent or improved following treatment at timed intervals [ Time Frame: 3 and 12 months post-operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Erin Leckrone, Boston Scientific
ClinicalTrials.gov Identifier: NCT00688181     History of Changes
Other Study ID Numbers: U8043
First Posted: June 2, 2008    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders