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

Urinary Incontinence Clinical Trial

— Mesh_Survey  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04010162
• Other study ID #: UU-SUAM-MREC-2018-13/11
• Status: Recruiting
• Start date: March 1, 2019
• Est. completion date: September 15, 2019

Study information

• Verified date: July 2019
• Source: Uludag University
• Contact: Adnan Orhan, M.D.
• Phone: +905056337102
• Email: dr.adnan.orhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: September 15, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Ozluce

Sponsors (2)

Lead Sponsor	Collaborator
Uludag University	King's College Hospital NHS Trust

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

LANE FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol. 1962 Jul;20:72-7. — View Citation

Lensen EJ, Withagen MI, Kluivers KB, Milani AL, Vierhout ME. Surgical treatment of pelvic organ prolapse: a historical review with emphasis on the anterior compartment. Int Urogynecol J. 2013 Oct;24(10):1593-602. doi: 10.1007/s00192-013-2074-2. Epub 2013 Mar 15. Review. — View Citation

Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with anterior compartment prolapse. Cochrane Database Syst Rev. 2016 Nov 30;11:CD004014. Review. — View Citation

Nygaard IE, McCreery R, Brubaker L, Connolly A, Cundiff G, Weber AM, Zyczynski H; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy: a comprehensive review. Obstet Gynecol. 2004 Oct;104(4):805-23. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 minute
Secondary	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).	1 minute