The Prefyx PPS™ System eRegistry

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2009-04-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Stress Urinary Incontinence

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects treated with the Prefyx PPS System

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.

The Prefyx PPS™ Pre-pubic Sling System

Intervention Type DEVICE

device designed to treat female stress urinary incontinence (SUI).

Interventions

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The Prefyx PPS™ Pre-pubic Sling System

device designed to treat female stress urinary incontinence (SUI).

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No