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| General |
| Study Status |
Other |
| 522 Number / Requirement Number |
PS120035 / PSS001 |
| Date Original Plan Accepted |
07/08/2013
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| Date Current Plan Accepted |
06/20/2014
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| Study Name |
POP AE and Effectiveness rates, registry
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| Device Name |
Exair anterior and posterior prolapse repair systems
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| Root Document Number |
K083499
K112386
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
External Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
"The proposed study is a multicenter, non-randomized, cohort study of Exair for the treatment of transvaginal repair of POP among patients with clinically documented POP and symptomatic POP. The primary study hypothesis is that at 36 months following surgical treatment for POP, the proportion of prolapse recurrence (defined as prolapse below the hymenal ring or awareness of protrusion or bulge of any compartment or retreatment, including the introduction of a pessary after index procedure of Pelvic Organ Prolapse in the target compartment) in the Exair Group will be non-inferior to the proportion of prolapse recurrence in the NTR group. There is no comparator device that will be used for this study. The study will be comparing
Exair/NovaSilk mesh to native tissue repair for the treatment of pelvic organ prolapse. The native tissue repair cohort will be a shared common control cohort across multiple sponsors that are participating in the national registry. Common inclusion and exclusion criteria as well as post-hoc analyses will ensure consistency and poolability across the shared cohort."
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| Study Population |
The study population will consist of adult female subjects with pelvic organ prolapse that are clinically indicated for surgical intervention for pelvic floor reconstruction.
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| Sample Size |
338 subjects (169 patients treated with Exair Anterior and Posterior Prolapse Repair Systems and 169 patients treated with Native Tissue Repair) will be enrolled at up to 25 study centers.
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| Key Study Endpoints |
Primary effectiveness endpoint: Recurrent prolapse; Primary Safety Endpoint: Device or procedure-related adverse events (AEs) of interest; Secondary Endpoints: 1. Rates of all other adverse events; 2. Primary and secondary safety endpoints stratified by compartment; 3. Primary and secondary safety endpoints listed by severity; 4. Primary and secondary efficacy outcome stratified by compartment; 5. Primary and secondary safety endpoints stratified by subjects requiring and not requiring re-surgery after the initial transvaginal pelvic organ prolapse surgery overall, and stratified by compartment; 6. Quality of life score differences from baseline overall, and stratified by compartment; 7. Quality of life score improvement from baseline for subjects requiring re-surgery following the index procedure overall, and stratified by compartment; 8. Quality of life score improvement from baseline for subjects with similar conditions with and without surgical intervention (e.g. pessary); 9. Prolapse at or beyond the hymenal ring just prior to mesh removal surgery among those who have and have not had all or part of their mesh removed post-operatively; 10. Bulge for each vaginal compartment in which mesh is placed; 11. Revision and/or re-surgery; 12. Recurrent prolapse.
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| Follow-up Visits and Length of Follow-up |
The length of study follow-up is 3 years. Follow-up will be conducted at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
79 (53 were treated in the mesh arm and 5 in the native tissue repair arm [NTR])
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| Actual Number of Sites Enrolled |
14
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| Patient Followup Rate |
2-month follow-up: 31% mesh arm and 3% NTR, 6-month follow-up: 9.5% mesh arm and 1% NTR. No patients completed 12, 18, 24, and 36 months follow-up visits.
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| Final Safety Findings |
From a total of 20 AEs 34.5% (20/58), four AEs 6.9% (4/58) were mild, 14 moderate 24.1% (14/58), and two severe 3.5% (2/58). None were NTR related. Eleven 19% (11/58) were related to the procedure including one severe (hypotension) 1.7% (1/58) that was resolved, seven moderate 12.1% (7/58) and three mild 5.2% (3/58). Among those related to the procedure, two moderate 3.5% and two mild 3.5% were not resolved. AEs unrelated to the device or the procedure include a hematoma retroperitoneal 1.7% (1/58) considered severe that was resolved, and seven moderate and one mild recovering or resolved. CEC only considered three of them as related to the Mesh device including: pain being mild and resolved 1.7%, recurrent uterine prolapse that was moderate and not resolved 1.7%, and right buttock numbness that was an unresolved, mild, device and procedure related AE 1.7%. There were four cases 6.9% (4/58) of urinary tract infection, three of them were related to the procedure and the other one not related to the procedure or the device, two cases of vaginal infection 3.4% (3/58), one of them related to the procedure and the other one not related to the procedure or the device, and one new case of difficulty emptying bladder 1.7% (1/58) that was related to the device.
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| Final Effectiveness Findings |
No results were reported due to early study termination
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| Study Strengths and Weaknesses |
Strengths:
None
Weaknesses:
a. The study was discontinued prematurely because the device is no longer marketed before the 522 order questions could be addressed.
b. Only 23% (79/338) of the target sample size was enrolled. This small sample size makes difficult any meaningful analyses.
c. Only a few subjects were followed for 2 and 6 months while a 36 months follow-up was expected as per protocol. This shorter follow-up cannot provide any evidence to assess any study endpoints.
d. A disproportionate enrollment between arms (53 were treated in the mesh arm and 5 in the NTR arm) makes very difficult any valid comparison.
e. Given that the study was discontinued prematurely, no statistical or descriptive analysis was conducted. Without any analysis, the 522 order questions cannot be answered.
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| Recommendations for Labeling Changes |
The device is not being marketed. The 522 study was discontinued prematurely without any reasonable safety and effectiveness results or analyses, there are no meaningful results that can be update the current labeling.
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