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The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.
Vaginal prolapse (a feeling of bulge in the vagina) may cause some distressing symptoms such as loss of control of the bowel or bladder, and may also cause problems with women's sex life. There are a number of different surgical procedures which are used to repair prolapse. Sometimes a mesh is placed in the pelvis to support the weakened tissues. There is a lot of research going on to find the most suitable type of mesh to repair vaginal prolapse. The GYNECARE PROLIFT + M* Pelvic Floor Repair system is similar to a mesh already used for this procedure called ULTRAPRO*, but is lighter in weight. Currently, ULTRAPRO* is only approved for use in hernia repair and is not licensed for gynecological procedures. This study will be the first clinical investigation of this mesh in vaginal prolapse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | GYNECARE PROLIFT+M* Pelvic Floor Repair System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GYNECARE PROLIFT+M* Pelvic Floor Repair System | Device | Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Organ Prolapse Quantification (POP-Q) score | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of treated compartment ICS POP-Q stage | 3, 12, 24 and 36 months | |
| Proportion of subjects with the leading edge within the hymen and without further re-intervention for POP | 12, 24 and 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Women over 18 with symptomatic pelvic organ prolapse of ICS POP-Q Stage III or IV, suitable for surgical repair.
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| Name | Affiliation | Role |
|---|---|---|
| David Robinson, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sint Lodewijkstraat 78 | Genk | Belgium | ||||
| CHRU de Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20965491 | Result | Milani AL, Hinoul P, Gauld JM, Sikirica V, van Drie D, Cosson M; Prolift+M Investigators. Trocar-guided mesh repair of vaginal prolapse using partially absorbable mesh: 1 year outcomes. Am J Obstet Gynecol. 2011 Jan;204(1):74.e1-8. doi: 10.1016/j.ajog.2010.08.036. Epub 2010 Oct 20. |
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|
| Incidence of de novo prolapse (a post-operative prolapse)only in the untreated compartment, provided there was no pre-operative defect in that compartment | Procedure to 36 months |
| Mean scores and change from baseline in PFDI-20 scores, including sub scores (POPDI, CRADI and UDI | 3, 12, 24 and 36 months |
| Mean scores and change from baseline in PFIQ-7, including sub-scores (POPIQ, CRAIQ and UIQ). | 3, 12, 24 and 36 months |
| Days to return to normal activities (walking, driving, work, household activities and sexual intercourse) | 1, 3, and 12 months |
| Assessment of sexual function using PISQ-12 (mean scores and change from baseline) in subjects sexually active at baseline | 12, 24 and 36 months |
| Incidence of new onset dyspareunia, resolution or continuance of pre-existing dyspareunia | Baseline to 36 months |
| Adverse Events | Procedure to 36 months |
| Determination of any exposures/erosions including location | Procedure to 36 months |
| Summary of International Continence Society (ICS) Stages | 3, 24, and 36 months |
| Lille |
| 59037 |
| France |
| DRT Krankenhaus | Chemnitz | 09034 | Germany |
| Martin Luther University | Halle | 06097 | Germany |
| Kreiskrankenhaus | Hamelin | 31785 | Germany |
| Universitatsklinik Tubingen | Tübingen | 72076 | Germany |
| St. Marien-Hospital | Vechta | D-49377 | Germany |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| ID | Term |
|---|---|
| D052858 | Cystocele |
| D020047 | Rectocele |
| D006547 | Hernia |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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