Skip to main content
OpenTrials
Completed

NCT Number: NCT00688181

The Prefyx PPS™ System eRegistry

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

South Florida Urology Center, Pembroke Pines, Florida, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Prefyx PPS™ Pre-pubic Sling System

Device

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

Primary outcomes

  1. Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up

    Time frame: 3 months

    Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse

  2. Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up

    Time frame: 12 months

    Continence was measured by participant subjective feedback. Responses included: cured, significantly improved, slightly improved, same, slightly worse, or significantly worse

  3. Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression

    Time frame: 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).

  4. Number of Participants With Adverse Events

    Time frame: 12 months

    Adverse events were collected throughout the study and tabulated per severity, seriousness, and device-relatedness.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 2, 2008
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.