NCT04010162

Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study.

Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Uludag University · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pelvic Organ Prolapse
• Urinary Incontinence
• Complication of Surgical Procedure

Interventions

Type	Name	Description
OTHER	Mesh debate awareness survey	A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-09-01
• Completion: 2019-09-15
• First posted: 2019-07-08
• Last updated: 2019-07-09

Locations

1 site across 1 country: Turkey (Türkiye)