NCT01084889

Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 292 (actual)
• Sponsor: pfm medical gmbh · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cystocele
• Uterine Prolapse

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-04-01
• Primary completion: 2014-01-01
• Completion: 2016-06-01
• First posted: 2010-03-11
• Last updated: 2019-02-04

Locations

9 sites across 1 country: Germany