|
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P030030 / PAS001 |
| Date Original Protocol Accepted |
12/16/2004
|
| Date Current Protocol Accepted |
12/16/2004
|
| Study Name |
Tegress PAS
|
| Device Name |
URYX URETHRAL BULKING AGENT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
1. The Two-year Enhanced Surveillance Program (ESP) is actively soliciting adverse event information related to the use of Tegress Urethral Implant. The Program consists of two parts: (A) Two-part information card and (B) Quarterly contact with US physicians to obtain adverse event information. 2. The Five-year Registry's objectives are to evaluate long-term safety and effectiveness and to assess the incidence of material exposure and other adverse events. At time of this report, Bard has qualified 4 sites and planned to begin patient enrollment in the fall 2006. The anticipated enrollment table is listed in Appendix 2. An updated enrollment table would be required for the next postmarket report.
These two studies were terminated.
|
| Study Population |
Study population as per device indication. This device is indicated for transurethral injection in the treatment of adult women diagnosed with stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
|
| Sample Size |
N/A
|
| Key Study Endpoints |
Adverse events
|
| Follow-up Visits and Length of Follow-up |
N/A
|
| Interim or Final Data Summary |
| Interim Results |
PMA was withdrawn, see Final Safety findings
|
| Actual Number of Patients Enrolled |
N/A
|
| Actual Number of Sites Enrolled |
N/A
|
| Patient Follow-up Rate |
(1) For the Active surveillance System: the latest period for which FDA has data - The return rate was 53% (3203 returned/ 6071 unit sales). (2) For the Registry: protocol was approved by the FDA on 5/23/06. PMA withdrawn April 6, 2007; No PAS report for the Registry was received.
|
| Final Safety Findings |
Safety issues identified in the last Report received for the Active Surveillance System: The adverse events observed (such as erosion, necrosis, and rupture of the urethral wall) were not observed in the PMA trial. The exact mechanism of injury for the various cases was unclear. Some plausible explanations were proposed by the FDA, such as cytotoxicity from the solvent used with the implant material; tissue necrosis from a combination of causes such as blood loss, pressure, and cytotoxicity; and rupture as a mechanical event as the elastic limit is exceeded when the implant material expands. The sponsor conducted biocompatibility testing by repeating cytotoxicity, chemical evaluation and implant studies and the projected completion dates were 9/15/06 and 5/31/07. As per CTS, the PMA was withdrawn April 6, 2007
|
| Study Strengths & Weaknesses |
N/A
|
| Recommendations for Labeling Changes |
None, PMA withdrawn
|
