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A prospective, single arm, multi-center clinical study to evaluate the safety and performance of the SRS (Lyra Medical) vaginal mesh in POP patients
The SRS implant is intended for transvaginal surgical treatment of anterior vaginal wall prolapse with or without vaginal apex/uterine prolapses
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm | Experimental | Subjects suffering from anterior POP-Q grade 2 (point Aa and Ba≥ -1) and above, who are scheduled for POP surgery, will be transplanted with the SRS device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRS - Self Retaining Support system | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in POP-Q points Aa and Ba | Points Aa and\or Ba are less than -1 | 36 months |
| Improvement in POP-Q point C: | Point C at -5 or less | 36 months |
| No unexpected serious adverse device related events | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Achieving normal urinary function: | Patient does not experience voiding dysfunction and have negative Urinary Cough Test. | 36 Months |
| Improvement in Quality Of Life (QoL) | Subjective bother involving pelvic floor disorders using validated scales including PFDI-20 and PSIQ-12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayanei HaYeshua Medical Center | Bnei Brak | 51544 | Israel | |||
| Ziv Medical center |
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| 36 Months |
| Safed |
| Israel |
| Asaf HaRofeh Medical Center | Zrifin | 70300 | Israel |