CClinicalTrials.gg
Status unknownNCT04010162Mesh_SurveyUpdated Jul 9, 2019

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

An observational study in Pelvic Organ Prolapse, Urinary Incontinence and Complication of Surgical Procedure, sponsored by Uludag University. Status unknown at 1 site in Turkey. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Uludag University · Observational

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
1,500
Ages
30 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • mesh complications
  • social media awareness
  • knowledge of doctors
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 120 across 305 observational studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Uludag University is the lead sponsor of 141 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Doctors from four different groups (1-KCH, 2-UUH, 3-USA, 4-WORLD) are expected to complete the questionnaire.

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
1,500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group-1: King's College Hospital

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

    Other: Mesh debate awareness survey

  • Group-2: Uludag University Hospital

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

    Other: Mesh debate awareness survey

  • Group-3: The United States

    Doctors from The United States (Excluding Urology and Gynecology)

    Other: Mesh debate awareness survey

  • Group-4: The World

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

    Other: Mesh debate awareness survey

Interventions

  • OtherMesh debate awareness survey

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

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What researchers measure

Primary outcomes

  1. 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

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Uludag University Hospital, Department of Obstetrics and Gynecology
    Bursa, Ozluce 16059, Turkey
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23494056 ↗
  • LANE FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol. 1962 Jul;20:72-7. doi: 10.1097/00006250-196207000-00009. No abstract available. PubMed 14462011 ↗
  • 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(11):CD004014. doi: 10.1002/14651858.CD004014.pub6. PubMed 27901278 ↗
  • 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. doi: 10.1097/01.AOG.0000139514.90897.07. PubMed 15458906 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04010162
Lead sponsor
Uludag University
Collaborators
King's College Hospital NHS Trust
Responsible party
Adnan Orhan (Medical Doctor, Researcher, Obstetrician and Gynecologist, Uludag University) — Principal investigator
First posted
Jul 8, 2019
Start date
Mar 1, 2019
Primary completion
Sep 1, 2019 (estimated)
Completion
Sep 15, 2019 (estimated)
Last update
Jul 9, 2019

Study contacts

Adnan Orhan, M.D.
Contact
dr.adnan.orhan@hotmail.com
+905056337102
Angela Rantell, PhD
Contact
angela.rantell@nhs.net
+44 (0)20 3299 3568
Kemal Ozerkan, M.D.
study director · Uludag University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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