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The Prefyx PPS™ System eRegistry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2009 by Boston Scientific Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00688181
First received: May 28, 2008
Last updated: March 30, 2009
Last verified: March 2009
  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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on December 07, 2016