Clinical Trial: Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: pfm medical ag

Current Primary Outcome:

  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Adverse Events [ Time Frame: at 6, 12, 36 months ]
  • Feasibility of the mesh implantation [ Time Frame: 6 months ]
  • 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.


Original Secondary Outcome: Same as current

Information By: pfm medical ag

Dates:
Date Received: March 10, 2010
Date Started: April 2010
Date Completion:
Last Updated: December 5, 2016
Last Verified: December 2016