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Prolapse, VaginalNCT03527082

Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

An observational study of Prolapse, Vaginal, run by Epsom and St Helier University Hospitals NHS Trust.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a questionnaire study that is being performed to ascertain the knowledge and attitudes of women towards use of mesh in gynaecological surgery. Women over the age of 18, able to read and comprehend the information leaflet, sign and give informed consent will be eligible to participate. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prolapse, Vaginal
What is being tested?
Questionnaire
How many people
150 participants
Where
No sites listed yet
Study dates
Jul 2018to Jul 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 18 years and older
  • Women only
  • Adult, Older adult

Study population: Women attending gynaecology outpatient clinics at Epsom and St Helier's University Hospitals

Who may be able to join

  • a. Women > 18 years of age attending gynaecology clinics
  • Able to read and comprehend the details of the study in patient information sheet.
  • Mentally competent at signing the consent form.

Who cannot join

  • Patient refusal.
  • Inability to consent due to a language barrier (no translator available, medication)

About this study

This is a questionnaire study that is being performed to ascertain the knowledge and attitudes of women towards use of mesh in gynaecological surgery. Women over the age of 18, able to read and comprehend the information leaflet, sign and give informed consent will be eligible to participate. Women who are not fluent in English will be able to participate if a translator can convey the information. The trial will be conducted at Epsom and St Helier Hospitals, in the United Kingdom. The investigators aim to recruit 150 women to this study. No power calculation has been performed as this is an exploratory study.

However, previous studies have included 64 and 77 women respectively.

Read the detailed description

Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are common conditions experienced by women. It is estimated that 20% of women undergo surgery for the treatment of prolapse. Transvaginal placement of surgical mesh for repair of POP and SUI are associated with complications such as erosion, infection, dyspareunia, bowel and bladder perforation as well as failure of the operation. Such complications have resulted in the FDA reclassifying transvaginal meshes to high risk medical devices. Most recently, National Institute for Clinical Excellence (NICE) in the United Kingdom has limited the use of transvaginal meshes for anterior and posterior compartment prolapse to a research context only.

Since the FDA and NICE publications, there has been much controversy and increasing litigation arising from complications of transvaginal mesh use. Recent negative media attention has likely affected patients' perception regarding mesh use in gynaecology. There are no studies assessing the knowledge and perception of mesh use in gynaecological surgery within the United Kingdom. Previous studies have found patients have limited knowledge and often are misinformed. However, these have been limited to transvaginal meshes. Laparoscopic procedures using mesh for POP such as sacrohysteropexy and sacrocolpopexy are become increasingly popular with comparable outcomes to vaginal surgery. The risk of mesh erosion with laparoscopic surgery is less than vaginal placement.

The use of mesh of gynaecology remains a topical issues and given the amount of information available to patients, this concept merits study, as it may influence patients' decision making and therefore a prominent part of the consent process. The use of mesh in gynaecological surgery remains a highly effective method of treating POP and SUI in appropriately selected patients and routes. It is therefore important to understand patients' understanding and perception regarding mesh use and sources of information in the wake of media coverage and attention. The investigators seek to evaluate patients' knowledge and attitudes towards use of mesh in gynaecological surgery presenting to gynaecology clinics.

The investigators aim to survey 150 women attending gynaecology clinics using a questionnaire. A power calculation has not been performed however, similar studies have included 164 and 77 women respectively. The questionnaire consists of 20 questions that should take 10 minutes to complete.

Consent: A valid consent with detailed written information sheet will be sought before including them in this trial.

Inclusion and exclusion criteria: All women attending the clinic will be eligible to participate if they are over the age of 18, with an understanding of English or translator available and able to provide informed consent.

Risks and benefits: All women will receive the same standard of care regardless if they agree to disagree to participate in the trial. There are no disadvantages associated with participation in taking part in the study.

Data storage: All the information obtained from this study will be stored in a confidential manner and will only be available to the researchers for future analysis.Participants can withdraw their consent at any point and this will not affect the standard of care given to them in future.All the information pertaining to the trial will be destroyed securely.

This research does not involve any use, storage of any tissue

Being tested
Questionnaire
Keywords
mesh, erosion, transvaginal, prolapse, laparoscopic, tension free tape
Medical subject headings
Uterine Prolapse, Prolapse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Questionnaire of 20 items evaluating attitudes and perception of mesh use in gynaecological surgery. Questionnaire will take 10 minutes to complete. For non-English speaking patients a translator will be sought, where feasible to help women complete the questionnaire.

    Participation will be entirely voluntary and also the questionnaire will be piloted to ensure that questions asked are clear and concise. Questionnaire is anonymised and does not contain patient identifying information thereby eliminating breach of confidentiality.

Study groups in NCT03527082
Study groupRoleWhat they receive
Women attending gynaecology clinics150 women attending gynaecology clinics that fulfil inclusion criteria Inclusion criteria: Inclusion criteria 1. Over the age of 18 2. attending gynaecology clinics 3. Able to read and comprehend the details of the study in patient information sheet. 4. Mentally competent at signing the consent form. 5. English -speaking, if not then translator available
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery

    Assessed by use of questionnaire

    Measured: Duration of study, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study startJul 2018 (estimated)
  3. Primary completionMar 2019 (estimated)
  4. Study completionJul 2019 (estimated)

Resources

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
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03527082
Sponsor's protocol ID
IRAS ID 241922
Status last verified
Jan 2018
First submitted
4 May 2018
Last updated
18 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Brown LK, Fenner DE, Berger MB, Delancey JO, Morgan DM, Patel DA, Schimpf MO. Defining patients' knowledge and perceptions of vaginal mesh surgery. Female Pelvic Med Reconstr Surg. 2013 Sep-Oct;19(5):282-7. doi: 10.1097/SPV.0b013e31829ff765.

    PubMed 23982577
  • Dallenbach P, De Oliveira SS, Marras S, Boulvain M. Incidence and risk factors for mesh erosion after laparoscopic repair of pelvic organ prolapse by lateral suspension with mesh. Int Urogynecol J. 2016 Sep;27(9):1347-55. doi: 10.1007/s00192-016-2974-z. Epub 2016 Feb 17.

    PubMed 26886554
  • Dessie SG, Hacker MR, Haviland MJ, Rosenblatt PL. Attitudes toward transvaginal mesh among patients in a urogynecology practice. Int Urogynecol J. 2015 Jun;26(6):865-73. doi: 10.1007/s00192-014-2607-3. Epub 2015 Jan 17.

    PubMed 25595568
  • Iglesia CB. Synthetic vaginal mesh for pelvic organ prolapse. Curr Opin Obstet Gynecol. 2011 Oct;23(5):362-5. doi: 10.1097/GCO.0b013e32834a92ab.

    PubMed 21857223
  • Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.

    PubMed 23633316

Questions about this trial

What is this clinical trial studying?

An observational study of Prolapse, Vaginal, run by Epsom and St Helier University Hospitals NHS Trust.

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 3 inclusion and 2 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery (time frame: Duration of study, 12 months). 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 NCT03527082, which also lists 5 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 18 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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