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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS120093 / PSS001 |
| Date Original Plan Accepted |
01/31/2013
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| Date Current Plan Accepted |
08/29/2016
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| Study Name |
SUI AE and Effectiveness rates
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| Device Name |
Solyx Single Incision Sling System
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| Root Document Number |
K081275
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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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 |
This is a prospective, non-randomized, parallel cohort, multi-center study to examine whether the single incision sling will be non-inferior to the standard outside-in transobturator sling for the treatment of female stress urinary incontinence in safety and effectiveness at 36 months as compared to baseline.
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| Study Population |
Subjects who undergo a medical intervention (surgical or non-surgical) to treat recurrence, persistence of SUI, or a mesh complication.
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| Sample Size |
A total of 280 subjects (140 patients treated with Solyx Single Incision Sling System and 140 patients treated with Obtryx II Sling System as controls) will be enrolled at up to 30 study centers.
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| Key Study Endpoints |
Primary Endpoint: Improvement in stress urinary incontinence at 36 months as compared to Baseline, by a composite of objective and subjective measures. Secondary Endpoints: 1. Incidence of mesh erosion (vaginal or urethral); 2. Incidence of mesh exposure; 3. Incidence of de novo dyspareunia; 4. Improvement of leakage on Urogenital Distress Inventory (UDI) Questionnaire; 5. Improvement in subject specific outcomes ((Pelvic Impact Sexual (PISQ) Questionnaire, Incontinence Severity Index (ISI), Pelvic Floor Impact Questionnaire (PFIQ-7)); 6. Assessment of pain scores, measured by the Visual Analog Scale (VAS); 7. Assessment of subject's level of improvement, measured by the Global Impression of Improvement (PGI-I); 8. Time to spontaneously void; 9. Assessment of re-intervention and re-surgery for recurrence or persistence of SUI or mesh exposure/erosion.
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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 weeks, 6 weeks, 6 months, 12 months, 18 months, 24 months and 36 months. For each of the primary endpoint and serious adverse events, non-inferiority of the single-incision sling will be evaluated using a two-sided 90% confidence interval for the treatment difference (single-incision minus transobturator). The confidence interval will be calculated based on the pooling of treatment differences across propensity score strata. All statistical analyses will be performed by the sponsor per the statistical analysis plan. All analyses will be done using SAS (version 8.0 or higher) statistical software. Subject summary tables and data listings will be provided for the data collected.
Propensity score stratification will be used to adjust baseline characteristics (including patient based risk factors and site based risk factors) between treatment and control groups. Non-inferiority paired test will be used to test categorical data such as serious device or serious procedure related AEs including mesh-related complications between the two groups after matching. If the upper limit of the confidence interval for the difference between two groups is smaller than ¿, non-inferiority is claimed. Paired t-test for non-inferiority will be used to test continuous data including QOL score improvements between two groups after matching.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
291 enrolled, 281 considered intent to treat (141 Solyx and 140 Obtryx)
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| Actual Number of Sites Enrolled |
21
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| Patient Followup Rate |
Overall: 212/281 (75.4%) completed 36 month follow-up; Solyx: 104/141 (73.8%) completed 36 month follow-up; Obtryx: 108/140 (77.1%) completed 36 month follow- up. This was below the goal of 80%.
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| Final Safety Findings |
Adverse events: 10.6% of subjects in the Solyx arm and 15.7% of subjects in the Obtryx arm
Serious device or procedure related events: 8 serious AEs in the Solyx arm and 9 serious AEs in the Obtryx arm. The propensity-adjusted treatment difference of -1.2%, and the upper bound limit of the 90% confidence interval [-5.4%, 3.0%] was 3.0%, which is below the 10% margin needed to demonstrate non-inferiority. Therefore, Solyx demonstrated non-inferiority to Obtryx for device or procedure-related serious adverse events.
Secondary study endpoints:
1. Mesh erosions: 0% Solyx, 0.7% Obtryx
2. Mesh exposures: 2.8% Solyx, 4.3% Obtryx
3. De novo dyspareunia: 0.7% Solyx, 0% Obtryx
4. Leakage on UDI Questionnaire: scores generally improved after baseline by 6 months and then plateaued; the UDI change from baseline was significantly lower for the Obtryx treatment group at 36 months, but otherewise no statistically significant differences between groups
5. Improvement in PROs (PISQ, ISI, PFIQ-7): scores generally improved after baseline by 6 months and then plateaued; there were no statistically significant differences between groups
6. Pain scores on VAS: scores generall improved after baseline through 6 weeks; there were no statistically significant differences between groups
7. Global improvement on PGI-I: scores generally improved after baseline by 6 months and then plateaued; there were no statistically significant differences between groups
8. Time to spontaneously void: no statistically significant differences between groups
9. Re-surgery: the propensity score-adjusted difference in the proportion of subjects with re-surgery between Solyx and Obtryx is 1.7% with a 90% CI [-1.5%, 4.9%]
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| Final Effectiveness Findings |
The 36-month primary endpoint, assessment of the improvement in stress urinary incontinence compared to baseline, for subjects treated with the Solyx device was 66.7% (94/141) and for Obtryx was 68.6% (96/140) with missing data imputed as treatment failures. The propensity-adjusted treatment difference was -3.4% and the 2- sided 90% lower confidence interval [-13.3%, 6.5%] was above the pre-specified non- inferiority limit of 15%.
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| Study Strengths and Weaknesses |
Study strengths include that it was a prospective cohort study. Study weaknesses include the lack of distinguishing between urethral hypermobility and intrinsic sphincter deficiency as the underlying cause of SUI, as well as not performing urodynamic testing, per the FDA guidance. There is also the large number of deviations.
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| Recommendations for Labeling Changes |
No further recommended changes
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