The Prefyx PPS™ System eRegistry

Study Overview
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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).

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.

Official Title
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The Prefyx PPS™ System eRegistry

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: The Prefyx PPS™ Pre-pubic Sling System


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects treated with the Prefyx PPS System<br>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. | Device: The Prefyx PPS™ Pre-pubic Sling System<br>* device designed to treat female stress urinary incontinence (SUI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 3 months | 
| Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up | Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse | 12 months | 
| Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression | Substantial improvement is measured by the participants' subjective feedback of their incontinence if they are cured, improved, same, or worse. Patients' Global Impression measures satisfaction (satisfied, or not satisfied). | 12 months | 
| Number of Participants With Adverse Events | Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness. | 12 months |