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Clinical Trial Summary

This study evaluates the awareness of mesh discussions in urogynecology among non-urogynecologists. A web-based questionnaire will be sent to four groups. Group-1 is King's College Hospital doctors. Group-2 is Uludag University Hospital doctors. Group-3 is doctors from the United States, and Group-4 is doctors from all over the world.


Clinical Trial Description

There has been a great deal of discussion about mesh complications in urogynecology. During the following decade, vaginal mesh operations for pelvic organ prolapse increased exponentially all over the world, particularly in the United States. Once the complications started to increase, the publication of mesh-related complications on social and broadcast media and the increase of medico-legal claims the United States led to an extensive FDA (Food and Drug Administration) restriction on vaginal mesh procedures in 2013. On January 5, 2016, the FDA reclassified surgical mesh for transvaginal repair of the pelvic organ prolapse into class III, which require premarket approval. Finally, on April 16, 2019, the FDA ordered all manufacturers of urogynecological mesh intended for transvaginal repair to stop selling and distributing their products immediately. However, awareness of the other doctors in branches of medicine outside of gynecology and urology is unknown. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04010162
Study type Observational
Source Uludag University
Contact Adnan Orhan, M.D.
Phone +905056337102
Email dr.adnan.orhan@hotmail.com
Status Recruiting
Phase
Start date March 1, 2019
Completion date September 15, 2019

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