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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01705-36 | Other Identifier | ANSM |
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The primary objective of this study is to evaluate the efficacy of the UpholdTM LITE mesh over a 12 month follow up period, using a composite outcome including a good anatomical correction for both anterior and apical compartments (stage 0 or 1), no prolapse (bulge) symptoms (answer "no" at question 3 of the PFDI-20) and no reintervention for recurrent prolapse of the anterior or apical compartment.
Secondary objectives include the evaluation of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolapse patients recieving UpHold LITE | Experimental | Non-pregnant female patients >= 50 years who are not considering future pregnancies, who are diagnosed with uterine or vault prolapse with ICS POP-Q score of stage 2 or greater, who are receiving the UpholdTM LITE mesh kit and who agree to be in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UpholdTM LITE placement | Device | Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Apical anatomical success | Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS) | 12 months |
| Anterior vaginal wall anatomical success | Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS) | 12 months |
| Change from baseline in PFDI-20 scores | baseline to 12 lines |
| Measure | Description | Time Frame |
|---|---|---|
| Anterior vaginal wall anatomical success | Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS) | 6 months |
| Apical anatomical success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renaud de Tayrac, MD PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Camille Guérin | Châtellerault | 86106 | France | |||
| CHU de Clermont Ferrand - Hôpital Estaing |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31359498 | Result | Allegre L, Debodinance P, Demattei C, Fabbro Peray P, Cayrac M, Fritel X, Courtieu C, Fatton B, de Tayrac R. Clinical evaluation of the Uphold LITE mesh for the surgical treatment of anterior and apical prolapse: A prospective, multicentre trial. Neurourol Urodyn. 2019 Nov;38(8):2242-2249. doi: 10.1002/nau.24125. Epub 2019 Jul 29. |
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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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Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS)
| 6 weeks |
| Apical anatomical success | Presence/absence: anatomical success as concerns apical (uterine) support, defined as point C <= stage 1 per POP-Q scoreing (ICS) | 6 months |
| Anterior vaginal wall anatomical success | Presence/absence: anatomical success on anterior vaginal wall support, defined as point Ba < = stage 1 per POP-Q scoring (ICS) | 6 weeks |
| Change from baseline in PFDI-20 scores | baseline to 6 weeks |
| Change from baseline in PFDI-20 scores | baseline to 6 months |
| Change from baseline in PFIQ-7 scores | baseline to 6 weeks |
| Change from baseline in PFIQ-7 scores | baseline to 6 months |
| Change from baseline in PFIQ-7 scores | baseline to 12 months |
| Change from baseline in PISQ-12 scores | baseline to 6 months |
| Change from baseline in PISQ-12 scores | baseline to 12 months |
| length of hospital stay (days) | 6 weeks |
| Number of days necessary for return to normal activities | 6 weeks |
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | Day 1 |
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 6 weeks |
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 6 months |
| Visual analog scale for post-operative pain | score ranging from 0.0 to 10.0 | 12 months |
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | Day 1 |
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 6 weeks |
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 6 months |
| Mesh related morbidity | Presence/absence of mesh related morbidity (infection, erosion, pain, dyspareunia) | 12 months |
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 6 weeks |
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 6 months |
| Mesh contraction (cm) | Mesh contraction as determined by ultrasound measurement (cm) | 12 months |
| Patient satisfaction (PGI index) score | 6 weeks |
| Patient satisfaction (PGI index) score | 6 months |
| Patient satisfaction (PGI index) score | 12 months |
| Clermont-Ferrand |
| 63003 |
| France |
| CH de Dunkerque | Dunkirk | 59385 | France |
| CH de Gonesse | Gonesse | 95500 | France |
| CHRU de Lille - Hôpital Jeanne de Flandre | Lille | 59037 | France |
| CHRU de Lyon - Hôpital de la Croix Rousse | Lyon | 69317 | France |
| APHM - Hôpital de la Conception | Marseille | 13385 | France |
| Clinique Beau Soleil | Montpellier | 34070 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| CHU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
| CH Louis Giorgi | Orange | 84106 | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Hôpital Foch | Suresnes | 92150 | France |