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

Bursa Uludag University

Status: Unknown

Conditions: Complication of Surgical Procedure; Pelvic Organ Prolapse; Urinary Incontinence

Treatments: Other: Mesh debate awareness survey

Study type: Observational

Funder types: Other

Identifiers

NCT04010162

UU-SUAM-MREC-2018-13/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Doctors from all branches of medicine
• Basic sciences: Immunology, Medical Biochemistry, Microbiology and Infectious Diseases, Forensic Medicine, Family Medicine, Public Health, Medical genetics, Medical pharmacology.
• Pediatrics: Pediatric allergy, Pediatric respiratory, Pediatric dentistry, Pediatric endocrinology, Pediatric gastroenterology and nutrition, Pediatric haematology, Pediatric nephrology, Pediatric neurology, Pediatric oncology, Pediatric ophthalmology, Pediatric surgery, Child and adolescent psychiatry, Pediatric orthopedics.
• Basic internal medicine specialties: Gastroenterology, Medical Oncology, Rheumatology, Hematology, Nephrology, Endocrinology
• Other internal medicine specialties: Neurology, Nuclear medicine, Radiology, Radiation Oncology, Psychiatry, Sport medicine, Respiratory medicine, Physical medicine and rehabilitation, Geriatrics, Dermatology, Cardiology
• Surgical Departments: Emergency and Accident Medicine, Heart and vascular surgery, Ophthalmatology, Orthopedics and Traumatology, Plastic and reconstructive surgery, Medical pathology, Anesthesiology and reanimation, Neurosurgery, General surgery, Chest surgery

Exclusion criteria

• Obstetricians and Gynaecologists,
• Urogynecologists,
• Urologists,
• Perinatologists ,
• Gynecological Oncologists,
• Doctors from Reproductive Endocrinology and Infertility,
• Uro-oncologists
• Andrologists.

Trial design

1,500 participants in 4 patient groups

Group-1: King's College Hospital

Description:

Doctors in King's College Hospital, London, The United Kingdom (Excluding Urology and Gynecology)

Treatment:

Other: Mesh debate awareness survey

Group-2: Uludag University Hospital

Description:

Doctors in Uludag University Hospital, Bursa, Turkey (Excluding Urology and Gynecology)

Treatment:

Other: Mesh debate awareness survey

Group-3: The United States

Description:

Doctors from The United States (Excluding Urology and Gynecology)

Treatment:

Other: Mesh debate awareness survey

Group-4: The World

Description:

Doctors from all over the world (Excluding Urology and Gynecology)

Treatment:

Other: Mesh debate awareness survey