NCT02690220

Anterior Pelvic Prolapse Reconstruction With TiLOOP® PRO A Polypropylene Mesh

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (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 titanized polypropylene mesh on patients quality of life.

Detailed 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.

Conditions

• Cystocele
• Uterine Prolapse

Interventions

Type	Name	Description
DEVICE	TiLOOP® PRO Plus A	The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-02-24
• Last updated: 2019-10-23

Locations

5 sites across 1 country: Germany