ational, multicentre post market surveillance study on anterior pelvic prolapse reconstruction with a titanium-coated polypropylene mesh (TiLOOP® PRO A) - TiLOOP® PRO A

pfm medical ag0 sites54 target enrollmentMarch 1, 2016

Overview

No summary available.

Registry

who.int

Start Date

March 1, 2016

End Date

July 31, 2017

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

pfm medical ag

•1\. Existence of a cystocele. Women with a symptomatic genital descensus: at least
•stage II (ICS\-classification according POP\-Q system). This applies to primary as
•well as recurrent intervention.
•2\. Patient is mentally able to understand the nature, aims, or possible
•consequences of the clinical investigation.
•3\. Patient information has been handed out and written consent is at hand.
•4\. Patient has attained full age (18 years or older).

•1\. Unfinished family planning, pregnancy or breast\-feeding mother.
•2\. Known intolerance to the mesh\-implants under investigation.
•3\. Lack of written patients’ informed consent.
•4\. Lack of patient compliance regarding data collection, treatment or follow\-up investigations in the scope of the protocol.
•5\. Patients with acute (within the last 12 months) carcinoma in the pelvic area.
•6\. Patients with history of radiotherapy in the pelvic area.
•7\. Patients with implanted anterior pelvic floor mesh.
•8\. Patient is institutionalized by court or official order (MPG §20\.3\).
•9\. Participation in another interventional clinical investigation.