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| Name | Class |
|---|---|
| Aix Scientifics | INDUSTRY |
| GfE Medizintechnik GmbH | OTHER |
| pfm medical titanium gmbh | UNKNOWN |
| Bayes GmbH |
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The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.
It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| symptomatic genital descensus | Women with a symptomatic genital descensus : at least stage II (ICS-classification according pelvic organ prolapse quanification (POP-Q) system), or stage I with a symptomatic requiring intervention. Standard method to implant the TiLOOP® Total 6 surgical mesh transvaginally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| surgical mesh implantation (TiLOOP® Total 6) | Device | The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms. |
| Measure | Description | Time Frame |
|---|---|---|
| Erosion rate | Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament. | 12 months |
| Patient's quality of life | It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Documentation and independent evaluation of all complications. | at 6, 12, 36 months |
| Feasibility of the mesh implantation | Evaluation of questions on usability. |
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Inclusion Criteria:
Exclusion Criteria:
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Women with a symptomatic genital descensus treated in the center
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| Name | Affiliation | Role |
|---|---|---|
| Christian Fünfgeld, Dr. MD | Klinik Tettnang GmbH, Tettnang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berliner Kontinenzzentrum am Franziskus Krankenhaus, | Berlin | 10787 | Germany | |||
| Krankenhaus Dresden- Friedrichsstadt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26781262 | Result | Farthmann J, Mengel M, Henne B, Grebe M, Watermann D, Kaufhold J, Stehle M, Fuenfgeld C. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016 Jul;294(1):115-21. doi: 10.1007/s00404-016-4014-0. Epub 2016 Jan 18. | |
| 28959063 |
| Label | URL |
|---|---|
| Quality of life and pelvic organ prolapse-related symptoms after pelvic floor reconstruction with a titanized polypropylene mesh for cystocele: long-term results in a 36 month follow-up by Fünfgeld et al, 2018 | View source |
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| ID | Term |
|---|---|
| D052858 | Cystocele |
| D014596 | Uterine Prolapse |
| D011391 | Prolapse |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| OTHER |
| Crolll Gmbh | OTHER |
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|
| 6 months |
| Erosion rate | Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament. | 36 months |
| Patient's quality of life | It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation. | 12 and 36 months |
| Dresden |
| 01067 |
| Germany |
| Evangelisches Diakoniekrankenhaus Freiburg | Freiburg im Breisgau | Germany |
| Universitätsklinikum Eppendorf | Hamburg | 20246 | Germany |
| St. Elisabeth Krankenhaus Leipzig, | Leipzig | 04277 | Germany |
| Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg | Ludwigsburg | 71640 | Germany |
| Beckenbodenzentrum München | München | 81679 | Germany |
| Klinik Tettnang GmbH | Tettnang | 88069 | Germany |
| Klinikum Oberlausitzer Bergland gGmbH, | Zittau | 02763 | Germany |
| Funfgeld C, Stehle M, Henne B, Kaufhold J, Watermann D, Grebe M, Mengel M. Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):993-1001. doi: 10.1055/s-0043-116857. Epub 2017 Sep 25. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D000091662 | Genital Diseases |