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Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

Cystocele Clinical Trial

Official title:
National, Multicentre Post Market Surveillance Study on Anterior Pelvic Prolapse Reconstruction With a Titanium-coated Polypropylene Mesh (TiLOOP® PRO A)

Clinical Trial Summary

The purpose of this study is to determine the influence of anterior pelvic prolapse reconstruction with a titanized polypropylene mesh on patients quality of life.

Clinical Trial Description

This multicentre, non-randomized, observational clinical investigation will be performed to obtain usability and postmarket information on the TiLOOP® pelvic floor reconstruction meshes and in particular to obtain the improvement of patients' quality of life.

It is expected that the patient's quality of life is meliorated after implantation of a TiLOOP® PRO A mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 12 months is significantly better than before implantation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02690220
Study type Interventional
Source pfm medical ag
Contact
Status Completed
Phase N/A
Start date February 1, 2016
Completion date July 31, 2017
View Details
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