The Prefyx PPS™ System eRegistry

Stress Urinary Incontinence Clinical Trial

Official title:

The Prefyx PPS™ System eRegistry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688181
• Other study ID #: U8043
• Status: Completed
• Start date: December 2006
• Est. completion date: April 2009

Study information

• Verified date: February 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: April 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• The Prefyx PPS™ Pre-pubic Sling System
device designed to treat female stress urinary incontinence (SUI).

Locations

Country	Name	City	State
United States	Urology Specialists of Atlanta, LLC /Northside Hospital	Atlanta	Georgia
United States	South Florida Urology Center	Pembroke Pines	Florida
United States	HillCrest Medical Center	Tulsa	Oklahoma
United States	OB/GYN Specialists of the Palm Beaches	West Palm Beach	Florida
United States	Affiliates in Urology	Westland	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Adverse Events	Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.	12 months

External Links

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