The Prefyx PPS™ System eRegistry

Boston Scientific

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: The Prefyx PPS™ Pre-pubic Sling System

Study type: Observational

Funder types: Industry

Identifiers

NCT00688181

U8043

Details and patient eligibility

About

Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 1 patient group

Subjects treated with the Prefyx PPS System

Description:

All patients presenting to the institution for treatment of female Stress Urinary Incontinence (SUI), excluding those patients meeting any of the contraindications as noted in the Directions For Use.

Treatment:

Device: The Prefyx PPS™ Pre-pubic Sling System