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The retrospective patient chart review aims to generate additional data to substantiate the safety and performance of EndoGYNious and PelviGYNious.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoGYNious | Patient received EndoGYNious mesh implant. |
| |
| PelviGYNious | Patient received PelviGYNious mesh implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PelviGYNious | Device | Patient received PelviGYNious implant. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Patient subjective outcome | Patient subjective outcome after POP treatment with EndoGYNious or PelviGYNious will be measured with a validated questionnaire (German Pelvic Floor Questionnaire "Deutscher Beckenboden-Fragebogen") . This questionnaire focus on 4 items (bladder, bowel, prolapse, sexuality). Each item has its scores, scores were summed up for each category (bladder max. 45, bowel max. 34, prolapse max. 15, sexual max. 21), Calculation: (achieved value of category/ max. value of category)*10; max. value 10 for each category, max. final score 40 The postoperative scores will be compared with the preoperative scores. | From baseline to the end of last follow-up [3 months, 12 months] |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | To analyze postoperative complications in women undergoing POP treatment with EndoGYNious or PelviGYNious during the follow up period. The occurrence of each complicaiton/adverse event will be compared to the occurrence of the same complication by similar products or other state of the art treatments | From baseline to the end of last follow-up [average of minimum 3 months] |
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Inclusion Criteria:
Exclusion Criteria:
Patients who rule out subsequent contact by the hospital will be excluded.
The use of the products is contraindicated in case of:
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The planned clinical investigation is a retrospective chart review of clinical data.
All patients who underwent surgery between January 2016 and December 2023 and met the inclusion criteria and no exclusion criteria were analyzed.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Erlangen, Frauenklinik | Erlangen | Germany |
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| ID | Term |
|---|---|
| D011391 | Prolapse |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| EndoGYNious |
| Device |
Patient received EndoGYNious implant. |
|
| Anatomical success (POP-Q) | POP-Q system according to ICS with POP-Q stages 0, I, II, III, IV The postoperative POP-Q stages (overall, apical compartment, anterior compartment, posterior compartment) will be compared to the preoperative POP-Q stages. | From baseline to the end of last follow-up [average of minimum 3 months] |