Pelvic Organ ProlapseMesh_SurveyNCT04010162
Mesh Debate Awareness Among Non-urogynecologists. A Practical Survey Study.
An observational study of Pelvic Organ Prolapse and Urinary Incontinence, run by Uludag University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence, Complication of Surgical Procedure
- What is being tested?
- Mesh debate awareness survey
- How many people
- 1,500 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 15 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Doctors from four different groups (1-KCH, 2-UUH, 3-USA, 4-WORLD) are expected to complete the questionnaire.
Who may be able to join
- 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
Who cannot join
- Obstetricians and Gynaecologists,
- Urogynecologists,
- Urologists,
- Perinatologists ,
- Gynecological Oncologists,
- Doctors from Reproductive Endocrinology and Infertility,
- Uro-oncologists
- Andrologists.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Ozluce, 16059
Adnan Orhan, M.D., +90 505 6337102, dr.adnan.orhan@hotmail.com
Isil Kasapoglu, M.D, +905305455848, kasapogluisil@hotmail.com
About this study
Official title: Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study.
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.
- Being tested
- Mesh debate awareness survey
- Keywords
- mesh complications, social media awareness, knowledge of doctors
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Group-1: King's College Hospital | Doctors in King's College Hospital, London, The United Kingdom (Excluding Urology and Gynecology) Receives: Other: Mesh debate awareness survey | |
| Group-2: Uludag University Hospital | Doctors in Uludag University Hospital, Bursa, Turkey (Excluding Urology and Gynecology) Receives: Other: Mesh debate awareness survey | |
| Group-3: The United States | Doctors from The United States (Excluding Urology and Gynecology) Receives: Other: Mesh debate awareness survey | |
| Group-4: The World | Doctors from all over the world (Excluding Urology and Gynecology) Receives: Other: Mesh debate awareness survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start1 Mar 2019
- Primary completion1 Sep 2019 (estimated)
- Study completion15 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Responsible party
- Principal investigator, Adnan Orhan, Uludag University
- Investigators
- Kemal Ozerkan, M.D., Study director, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010162
- Sponsor's protocol ID
- UU-SUAM-MREC-2018-13/11
- Acronym
- Mesh_Survey
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23494056LANE FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol. 1962 Jul;20:72-7. doi: 10.1097/00006250-196207000-00009. No abstract available.
PubMed 14462011Maher 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 27901278Nygaard 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Media Awareness Level of Non-urogynecologist Doctors About the Current Mesh Discussions in Urogynecology: A Practical Survey Study.
- ClinicalTrials.gov ID
- NCT04010162
- Acronym / sponsor ID
- Mesh_Survey / UU-SUAM-MREC-2018-13/11
- Keywords
- mesh complications, social media awareness, knowledge of doctors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Collaborators
- King's College Hospital NHS Trust
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 15 Sep 2019 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group-1: King's College Hospital | – | Other: Mesh debate awareness surveyDoctors in King's College Hospital, London, The United Kingdom (Excluding Urology and Gynecology) |
| Group-2: Uludag University Hospital | – | Other: Mesh debate awareness surveyDoctors in Uludag University Hospital, Bursa, Turkey (Excluding Urology and Gynecology) |
| Group-3: The United States | – | Other: Mesh debate awareness surveyDoctors from The United States (Excluding Urology and Gynecology) |
| Group-4: The World | – | Other: Mesh debate awareness surveyDoctors from all over the world (Excluding Urology and Gynecology) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Doctors from four different groups (1-KCH, 2-UUH, 3-USA, 4-WORLD) are expected to complete the questionnaire.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Obstetricians and Gynaecologists,
- Urogynecologists,
- Urologists,
- Perinatologists ,
- Gynecological Oncologists,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesh debate awareness surveyA web-based questionnaire with questions about recent discussions of mesh in urogynecology. 10 questions. Average survey completion time: 1 minute | Other | Group-1: King's College Hospital, Group-2: Uludag University Hospital, Group-3: The United States, Group-4: The World |
Primary outcome
Awareness of the current mesh discussion in urogynecology.
Time frame: 1 minute
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 secondary outcome
Social media awareness about the mesh discussions in urogynecology
Time frame: 1 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Background: PubMed 23494056Lensen 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.
- Background: PubMed 14462011LANE FE. Repair of posthysterectomy vaginal-vault prolapse. Obstet Gynecol. 1962 Jul;20:72-7. doi: 10.1097/00006250-196207000-00009. No abstract available.
- Background: PubMed 27901278Maher 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.
- Background: PubMed 15458906Nygaard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kemal Ozerkan, M.D. study director
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Urinary Incontinence, run by Uludag University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adnan Orhan, M.D. (+905056337102, dr.adnan.orhan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Awareness of the current mesh discussion in urogynecology. (time frame: 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010162, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.