The Prefyx PPS™ System eRegistry

NCT00688181 | Completed Results

• 1 other identifier: U8043
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

Device: The Prefyx PPS™ Pre-pubic Sling System

Interventions

The Prefyx PPS™ Pre-pubic Sling System DEVICE

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

Subjects treated with the Prefyx PPS System

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting to the institution for treatment of female Urinary Stress Incontinence (SUI) should be eligible for enrollment in the PPS eRegistry. However, any patient meeting any of the contraindications should NOT be included as noted in the Directions For Use. Minors are excluded from the registry per contraindications in which mesh implants are contraindicated in 'patients with the potential for future growth'.

You may qualify if:

• Patients presenting for treatment of female Urinary Stress Incontinence (SUI)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

South Florida Urology Center

Pembroke Pines, Florida, 33028, United States

Location

OB/GYN Specialists of the Palm Beaches

West Palm Beach, Florida, 33401, United States

Location

Urology Specialists of Atlanta, LLC /Northside Hospital

Atlanta, Georgia, 30328, United States

Location

Affiliates in Urology

Westland, Michigan, 48186, United States

Location

HillCrest Medical Center

Tulsa, Oklahoma, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Clinical Operations
• Organization: Boston Scientific Corporation

Teresa.Takle-Flach@bsci.com

(952) 930-6300

Study Officials

• Robert Walsh, M.D.

  Boston Scientific Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2008
• First Posted: June 2, 2008
• Study Start: December 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 1, 2021
• Results First Posted: March 1, 2021

Record last verified: 2021-02

Locations

US (5)