Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01084889|
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment|
|Cystocele Uterine Prolapse||Device: surgical mesh implantation (TiLOOP® Total 6)|
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.
|Study Type :||Observational|
|Actual Enrollment :||292 participants|
|Official Title:||National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)|
|Actual Study Start Date :||April 2010|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||June 2016|
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.
Device: surgical mesh implantation (TiLOOP® Total 6)
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.
Other Name: TiLOOP® Total 6
- Erosion rate [ Time Frame: 12 months ]Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
- Patient's quality of life [ Time Frame: 6 months ]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.
- Adverse Events [ Time Frame: at 6, 12, 36 months ]Documentation and independent evaluation of all complications.
- Feasibility of the mesh implantation [ Time Frame: 6 months ]Evaluation of questions on usability.
- Erosion rate [ Time Frame: 36 months ]Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
- Patient's quality of life [ Time Frame: 12 and 36 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01084889
|Berliner Kontinenzzentrum am Franziskus Krankenhaus,|
|Berlin, Germany, 10787|
|Krankenhaus Dresden- Friedrichsstadt|
|Dresden, Germany, 01067|
|Evangelisches Diakoniekrankenhaus Freiburg|
|Hamburg, Germany, 20246|
|St. Elisabeth Krankenhaus Leipzig,|
|Leipzig, Germany, 04277|
|Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg|
|Ludwigsburg, Germany, 71640|
|München, Germany, 81679|
|Klinik Tettnang GmbH|
|Tettnang, Germany, 88069|
|Klinikum Oberlausitzer Bergland gGmbH,|
|Zittau, Germany, 02763|
|Principal Investigator:||Christian Fünfgeld, Dr. MD||Klinik Tettnang GmbH, Tettnang|