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| General |
| Study Status |
Other |
| 522 Number / Requirement Number |
PS120006 / PSS001 |
| Date Original Plan Accepted |
06/03/2013
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| Date Current Plan Accepted |
12/15/2015
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| Study Name |
POP AE and Effectiveness rates, registry
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| Device Name |
Ams elevate apical and posterior prolapse repair system with intepro lite
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| Root Document Number |
K082730
K121612
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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 Elevate Apical/Posterior Study is a prospective, multi-center, post-market cohort study designed to evaluate the long-term efficacy and safety of the Elevate Apical/Posterior Prolapse Repair System compared to Native Tissue Repair in the treatment of posterior or posterior/apical vaginal prolapse in females at least 18 years of age. The study will enroll an equal number of subjects into the Elevate and native tissue repair groups. The treating surgeon together with the subject will decide which treatment the subject will receive.
There are two primary (non-inferiority efficacy and non-inferiority safety) objectives in this study. Both primary objectives need to be met for this study to be considered successful. The primary superiority efficacy objective will be evaluated only if the primary non-inferiority efficacy objective is met. The secondary efficacy objective will be evaluated for non-inferiority and superiority following the same analysis methods as for the primary efficacy objective and it will only be evaluated after the primary non-inferiority efficacy objective is met.
Primary Objective
1. To compare treatment success rate (leading edge of prolapse is at or above the hymen, no feeling of bulge and no retreatment for POP in the target compartment) for the Elevate Apical and Posterior Prolapse Repair System to native tissue repair.
2. To compare the rate of device or procedure related serious adverse events in subjects receiving Elevate Anterior and Apical Prolapse Repair System to native tissue repair.
Secondary Objective
1. To compare treatment success rate (leading edge of prolapse is above the hymen, no feeling of bulge and no retreatment for POP in the target compartment) for the Elevate Apical and Posterior Prolapse Repair System to native tissue repair.
2. To compare the rate of repeat/revision surgery for prolapse arising from the same site/target compartment in subjects receiving Elevate to those with native tissue repair.
3. To compare changes in Quality of Life (QoL) in subjects receiving Elevate to those with native tissue repair.
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| Study Population |
Device Group: Women implanted with Elevate Apical/Posterior Prolapse Repair Systems.
Comparison Group: Women who underwent traditional native tissue repair (NTR).
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| Sample Size |
A total of 494 subjects (247 per study arm) will be enrolled at up to 40 study centers to achieve the primary endpoint of success at 36 months.
Effectiveness: Under the alternative hypothesis: PEAA = 82%, PNTR =80%, a sample size of 135 per group is required at 80% power level with a one-side alpha of 0.05 and a non-inferiority margin of -10%. Assuming 20% attrition rate at 3
years, a minimum of 338 subjects (i.e. 169 per group) are required at the time of enrollment.
Safety: Under the alternative hypothesis: PEAA = 10%, PNTR = 5%, a sample size of 197 per group is required at 80% power level with a one-side alpha of 0.05 and a non-inferiority margin of 12%. Assuming 20% attrition rate at 3 years, a minimum of 494 subjects (i.e. 247 per group) are required at the time of enrollment. Since a minimum sample size of 135 per group at 3 years is required for the primary efficacy objective and it is less than the minimum safety sample size, the sample size required for this study will be 494 assuming a 20% attrition rate.
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| Key Study Endpoints |
Primary Endpoints
1. The primary efficacy endpoint for subjects undergoing surgical treatment for POP is a dichotomous outcome: surgical treatment "success" or "failure." Subjects will be considered a surgical success for this composite outcome if each of the following 3 criteria are met:
Anatomic success (in the targeted compartment)
Posterior Segment: Leading edge anterior prolapse is at or above the hymen (POP-Q point Bp < 0)
Posterior and Apical Segments: Leading edge of the posterior and cervix/vaginal apex prolapse is at or above the hymen (POP-Q point Bp < 0 and C < -(1 /2 TVL))
Subjective success
Subject denies symptoms of vaginal bulging per PFD I-20 question 3, answering "No" or "Yes" but "Not at All" bothersome (< 2)
No retreatment for POP
No retreatment (target segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery.
2. Rate of device or procedural related serious adverse events through 36 months post primary prolapse repair.
Secondary Endpoints
1. The secondary efficacy endpoint for subjects undergoing surgical treatment for POP is a dichotomous outcome: surgical treatment "success" or failure.'' Subjects will be considered a surgical success for this composite outcome if each of the following 3 criteria are met:
Anatomic success (in the targeted compartment)
Posterior Segment : Leading edge of posterior prolapse is above the hymen or POP-Q point Bp < 0
Posterior and Apical Segment: Leading edge of the posterior and cervix/ vaginal apex prolapse is above the hymen (POP-Q point Bp Subjective success
Subject denies symptoms of vaginal bulging per PFDI-20 question 3, answering "No" or "Yes" but "Not at All" bothersome (< 2)
No retreatment for POP
No retreatment (target segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery.
2. Rate of repeat/revision surgery for prolapse arising from the same site/target compartment through 36 months post primary prolapse repair
3. Changes in QoL captured at baseline through 36 months utilizing the following validated instruments:
o PFDI 20-Pelvic Floor Distress Inventory
o PFIQ-7-Pelvic Floor Impact Questionnaire
o PISQ-12-Pelvic Organ Prolapse/Urinary Continence Sexual Questionnaire
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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 |
99
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| Actual Number of Sites Enrolled |
26
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| Patient Followup Rate |
Follow-up Rates for transvaginal mesh (TVM) arm: All 100% subjects completed procedure, 93.5% at two months, 84.8% at 6 months, 93.3% at 12 months, and 62.5% at 18 months.
Follow-up Rates for native tissue repair (NTR) arm: All 100% subjects completed procedure, 94.9% at two months, 78.6% at 6 months, 92.9% at 12 months, and 71.4% at 18 months.
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| Final Safety Findings |
The most common adverse event reported was Urinary Tract Infection (9/46 or 19.6% in the TVM group, and 7/39 or 17.9% in the NTR group), and Difficulty Emptying Bladder was the second most reported event (7/46 or 15.2% in the TVM group, and 13/39 or 33.3% in the NTR group). There was one event of TVM erosion. These events and the other events reported are known Potential Adverse Events described in the Indications for Use. There were no new safety concerns identified in the study.
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| Final Effectiveness Findings |
The composite effectiveness study endpoint was defined by anatomic success (POP-Q score), subjective success (PFDI-20 question 3), and no retreatment for POP. The composite success rate at each study visit was as follows: at 2 months post procedure, 36/42 (85.7%) TVM and 32/36 (88.9%) NTR; at 6 months, 24/27 (88.9%) TVM and 22/22 (100%) NTR; at 12 months, 11/13 (84.6%) TVM and 12/13 (92.3%) NTR; and at 18 months, 4/5 (80%) TVM and 5/5 (100%) NTR.
Statistical comparisons between groups were not performed due to early study suspension, and no definite conclusions can be made.
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| Study Strengths and Weaknesses |
Strength: The study design included a comparison group (native tissue repair).
Weakness: The study was ended early and subject follow-up was not completed; therefore, the study did not answer the 522 order questions and no conclusions can be made about the safety or effectiveness of this device.
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| Recommendations for Labeling Changes |
None
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