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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00688181 |
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Date of registration:
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28/05/2008 |
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Primary sponsor: |
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Public title:
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The Prefyx PPS™ System eRegistry
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Scientific title:
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The Prefyx PPS™ System eRegistry |
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Date of first enrolment:
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December 2006 |
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Target sample size:
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44 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00688181 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Robert Walsh, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boston Scientific Corporation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Stress Urinary Incontinence
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Intervention(s)
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Device: The Prefyx PPS™ Pre-pubic Sling System
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Primary Outcome(s)
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Evaluation of reported Adverse Events
[Time Frame: 12 months post operatively]
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The percentage of subjects who remain continent or improved following treatment at timed intervals
[Time Frame: 3 and 12 months post-operative]
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The percentage of subjects who report substantial improvement and consider the surgery successful, as measured by the Patient's Global Impression
[Time Frame: 12, 24 and 36 months post operatively]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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