N/A
N=36
The Prefyx PPS™ System eRegistry
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00688181 ↗Enrolled (actual)
36
Serious AEs
52.8%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up — 26 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- The Prefyx PPS™ Pre-pubic Sling System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Nov 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Remain Continent or Improved Following Treatment Through 3 Months Follow-up |
26 | — |
| PRIMARY Number of Participants Who Remain Continent or Improved Following Treatment Through 12 Months Follow-up |
8 | — |
| PRIMARY Number of Participants Who Report Substantial Improvement and Consider the Surgery Successful, as Measured by the Patient's Global Impression |
7 | — |
| PRIMARY Number of Participants With Adverse Events |
23 | — |
Summary
Registry to gather information about the long term use of the Prefyx PPS System for the treatment of Stress Urinary Incontinence (SUI).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00688181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.