The Prefyx PPS™ System eRegistry

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Device: The Prefyx PPS™ Pre-pubic Sling System

• Registration Number: NCT00688181
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-05-28
• Study First Submitted QC: 2008-05-28
• Study First Posted: 2008-06-02
• Primary Completion: 2008-11
• Study Completion: 2009-04
• Results First Submitted: 2010-10-18
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Results First Posted: 2021-03-01
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with the Prefyx PPS System	The Prefyx PPS™ Pre-pubic Sling 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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	12 months	Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.
Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up	12 months	Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up	3 months	Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse
Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression	12 months	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).

Trial Locations

Locations (5)

Urology Specialists of Atlanta, LLC /Northside Hospital; 🇺🇸 Atlanta, Georgia, United States

OB/GYN Specialists of the Palm Beaches; 🇺🇸 West Palm Beach, Florida, United States

South Florida Urology Center; 🇺🇸 Pembroke Pines, Florida, United States

Affiliates in Urology; 🇺🇸 Westland, Michigan, United States

HillCrest Medical Center; 🇺🇸 Tulsa, Oklahoma, United States