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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS130015 / PSS001 |
| Date Original Plan Accepted |
04/25/2014
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| Date Current Plan Accepted |
04/25/2014
|
| Study Name |
AE and Effectiveness Rates
|
| Device Name |
Contasure Needleless sling
|
| Root Document Number |
K063136
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The manufacturer used data from a published study to fulfill the postmarket surveillance (522) order. The study was a two arm prospective study that compared the safety and effectiveness outcomes of patients who were treated with Contasure Needleless sling and transobturator-TVT for stress urinary incontinence.
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| Study Population |
All patients affected by urodynamic Stress Urinary Continence (SUI) and a positive stress test, with or without associated genital prolapse, and treated with either Contasure Needleless Sling (treatment arm) or Gynecare TVT obturator system (comparison arm).
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| Sample Size |
143 patients in the treatment arm and 114 patients in the comparison arm
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| Key Study Endpoints |
Comparison of objective cure (Stress test-presence of a negative stress test) and subjective cure (patients¿ subjective impression measured by Sandvik Severity Index) rates between 2 groups (non-inferiority testing). 2. Comparison of adverse events such as organ perforation, bleeding (including hemorrhage and hematoma), mesh exposure in the vagina, mesh erosion into the bladder, pelvic pain, infection, de novo dyspareunia, urinary retention, recurrent incontinence, other urinary problems, neuro- muscular problems, revision/resurgery. 3. Comparison of quality of Life measured by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
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| Follow-up Visits and Length of Follow-up |
Baseline, 6 months, 12 months, 24 months and 36 months. Length of follow-up is 36 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
143 patients in the treatment arm and 114 patients in the comparison arm
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| Actual Number of Sites Enrolled |
1
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| Patient Followup Rate |
92% in the treatment arm and 95% in the comparison arm
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| Final Safety Findings |
The most common adverse events are de novo urge incontinence (ranged from 8.3% to 11.7% in the Contasure Needleless sling group through 36 months and from 13.0% to 15.8% in the TVT-o group) and recurrent incontinence (ranged from 13.6% to 15.6% in the Contasure Needleless sling group through 36 months and from 5.9% to 12.0% in the TVT-o group) for both groups. Of note, mesh erosion in the bladder was not observed in either group, and mesh exposure in vagina The following adverse events were not observed in either group through 36 months: Mesh erosion in the bladder, other pains, de novo dyspareunia, infection, other urinary problems and neuromuscular problems. According to the non-inferiority test results, Contasure Needleless sling is non-inferior to TVT-o for each adverse events at each time point, with the exception of recurrent incontinence at 6 months.
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| Final Effectiveness Findings |
The primary effectiveness endpoint of the study is ¿negative cough stress test¿. It was reported that 112 patients out of 130 in the Contasure and 95 patients out of 108 in the TVT-o group had negative cough test at 36 months. The results suggested that Contasure Needleless sling success rates are non-inferior to the comparator group at 12, 18 (imputed), 24 and 36 months, but not at 6 months. Regarding quality of life, both groups showed a statistically significant improvement in quality of life scores at the end of the study (at 36 months, ICIQ score improved from 5.64 (baseline) to 0.86 in the treatment arm and from 5.66 (baseline) to 0.80).
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| Study Strengths and Weaknesses |
The strength of the study is being a prospective study with a comparison arm and high follow-up rate. The weakness of the study is being a non-randomized study and lack of blinding.
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| Recommendations for Labeling Changes |
No labeling update. The study results on the long term data have been published (Franco EM and Tardiu LA. Contasure-Needleless single incision sling compared with transobturator TVT-O for the treatment of stress urinary incontinence: long-term results. Int Urogynecol J: 17 July 2014: published online)
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