This trial is active, not recruiting.

Condition stress urinary incontinence
Treatment the prefyx pps™ pre-pubic sling system
Sponsor Boston Scientific Corporation
Start date December 2006
End date November 2008
Trial size 44 participants
Trial identifier NCT00688181, U8043


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
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.
the prefyx pps™ pre-pubic sling system
device designed to treat female stress urinary incontinence (SUI).

Primary Outcomes

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
Evaluation of reported Adverse Events
time frame: 12 months post operatively
The percentage of subjects who remain continent or improved following treatment at timed intervals
time frame: 3 and 12 months post-operative

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title The Prefyx PPS™ System eRegistry
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Boston Scientific Corporation.