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

Uludag University1,500 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Pelvic Organ Prolapse Urinary Incontinence Complication of Surgical Procedure

Interventions

Mesh debate awareness surveyOTHER

A web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Uludag University Hospital, Department of Obstetrics and Gynecology

Bursa, Ozluce, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Awareness of the current mesh discussion in urogynecology.

Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-8).

Time frame: 1 minute

Secondary Outcomes

Social media awareness about the mesh discussions in urogynecology

Web-based survey about current mesh discussion in Urogynecology with ten simple questions will be answered by the doctors in four groups (Question-10).

Time frame: 1 minute

Central Contacts

Adnan Orhan, M.D.

CONTACT

+905056337102 dr.adnan.orhan@hotmail.com

Angela Rantell, PhD

CONTACT

+44 (0)20 3299 3568 angela.rantell@nhs.net

Data from ClinicalTrials.gov

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