The Prefyx PPS™ System eRegistry for Prepubic Clinical Study Subjects - Full Text View

Sponsored by:	Boston Scientific Corporation
Information provided by:	Boston Scientific Corporation
ClinicalTrials.gov Identifier:	NCT00688181

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. Subjects that participated in the Prepubic Post Market Clinical Study had their prepubic slings placed between 30/AUG/2004 and 28/MAR/2007. No additional procedures are required beyond the physician's standard of care and those that were performed at the time of the Clinical Study participation.

Condition	Intervention
Stress Urinary Incontinence	Device: The Prefyx PPS™ Pre-pubic Sling System

MedlinePlus related topics: Pelvic Support Problems Urinary Incontinence

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Prefyx PPS™ System eRegistry for Prepubic Clinical Study Subjects

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

The percentage of subjects who remain continent or improved following treatment at timed intervals [ Time Frame: 3, 12, 24 and 36 months post-operative ] [ Designated as safety issue: No ]
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: 36 months post-operative ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	December 2006
Estimated Study Completion Date:	November 2008
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort 1 Subjects that participated in the Prepubic Post Market Clinical Study and had their prepubic slings placed between 30/AUG/2004 and 28/MAR/2007.	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 subjects from clinical sites which participated in the Prepubic Post Market Clinical Study (U0299) with enrollment greater than eight subjects treated will be invited to participate in the Registry. These subjects were previously treated for female Urinary Stress Incontinence (SUI) under a similar clinical protocol. The clinical study patients will be included in a registry with subjects outside of the clinical study population.

Criteria

Inclusion Criteria:

Participated in the Prepubic Post Market clinical Study U0299

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
OB/GYN Specialists of the Palm Beaches
West Palm Beach, Florida, United States, 33401
South Florida Urology Center
Pembroke Pines, Florida, United States, 33028
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

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator:	Neeraj Kohli, M.D.	Brigham and Women's Hospital
Study Director:	Robert Walsh, M.D.	Boston Scientific Corporation

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Boston Scientific ( Kurt Douglass )
Study ID Numbers:	U8043
Study First Received:	May 28, 2008
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00688181
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Urinary Incontinence, Stress
Urologic Diseases

Urination Disorders
Stress
Urinary Incontinence

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009