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The purpose of the study is to determine the clinical cure rates of pelvic organ prolapse from subjects that had a robotic-assisted sacrocolpopexy using Alyte Y mesh and Restorelle Y smartmesh lightweight mesh.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repair with Alyte or Restorelle Y-Mesh | Women who underwent their index robotic-assisted laparoscopic sacrocolpopexy at Morristown Medical Center or Overlook Medical Center using either the Alyte Y-mesh or Restorelle Y-smartmesh between 1/2007 and 8/2011. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cure Rate | To be considered a "clinical cure" subjects must meet all of the following criteria: no re-operation for or non-surgical treatment of pelvic organ prolapse since the index surgery; no symptoms of vaginal bulge as measured by a validated symptom questionnaire; no Pelvic Organ Prolapse Quantification (POP-Q) points greater than 0; POP-Q point C less than or equal to -5; an answer of "satisfied" or "very satisfied" on validated Surgical Satisfaction Questionnaire | 5-6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Anatomic Outcome | POP-Q measurements of Pelvic Organ Prolapse will be measured comparing both mesh groups and entire combined cohort compared to 12 month findings | 5-6 year |
| Mesh exposure/erosion |
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Inclusion Criteria:
Exclusion Criteria:
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Women who had a robotic-assisted laparoscopic sacrocolpopexy using either mentioned Y-mesh during the listed timeframe. All of the index cases were performed by fellowship-trained FPMRS specialists.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urogynecology-Atlantic Health System | Morristown | New Jersey | 07960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31688526 | Derived | Culligan PJ, Lewis C, Priestley J, Mushonga N. Long-Term Outcomes of Robotic-Assisted Laparoscopic Sacrocolpopexy Using Lightweight Y-Mesh. Female Pelvic Med Reconstr Surg. 2020 Mar;26(3):202-206. doi: 10.1097/SPV.0000000000000788. |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The rate of mesh exposure or erosion will be measured
| 5-6 years |
| Complications | any other complications related to the index surgery will be documented | 5-6 years |
| Symptom Comparison | to compare related symptoms such as urinary frequency, bowel function, and sexual function both between mesh groups and for the entire group compared to 12 month findings | 5-6 years |
| Surgical Satisfaction | The validated Surgical Satisfaction Questionnaire will be used to measure overall surgical satisfaction | 5-6 years |