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.
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
- Conditions
- Prolapse, Vaginal
- 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 group | Role | What they receive |
|---|---|---|
| Women attending gynaecology clinics | 150 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.
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.
- First posted16 May 2018
- Study startJul 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prolapse, VaginalStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epsom and St Helier University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 23982577Dallenbach 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 26886554Dessie 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 25595568Iglesia CB. Synthetic vaginal mesh for pelvic organ prolapse. Curr Opin Obstet Gynecol. 2011 Oct;23(5):362-5. doi: 10.1097/GCO.0b013e32834a92ab.
PubMed 21857223Maher 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT03527082
- Acronym / sponsor ID
- IRAS ID 241922
- Conditions
- Prolapse, Vaginal
- Keywords
- mesh, erosion, transvaginal, prolapse, laparoscopic, tension free tape
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Epsom and St Helier University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 16 May 2018 (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 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.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women attending gynaecology clinics | – | Other: Questionnaire150 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women attending gynaecology outpatient clinics at Epsom and St Helier's University Hospitals
Key inclusion criteria (3 listed)
- a. Women > 18 years of age attending gynaecology clinics
Key exclusion criteria (2 listed)
- Patient refusal.
- Inability to consent due to a language barrier (no translator available, medication)
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 |
|---|---|---|
| QuestionnaireQuestionnaire 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. | Other | Women attending gynaecology clinics |
Primary outcome
Women's Knowledge and Attitudes to Use of Mesh in Gynaecological Surgery
Time frame: Duration of study, 12 months
Assessed by use of questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Background: PubMed 23982577Brown 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.
- Background: PubMed 26886554Dallenbach 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.
- Background: PubMed 25595568Dessie 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.
- Background: PubMed 21857223Iglesia CB. Synthetic vaginal mesh for pelvic organ prolapse. Curr Opin Obstet Gynecol. 2011 Oct;23(5):362-5. doi: 10.1097/GCO.0b013e32834a92ab.
- Background: PubMed 23633316Maher 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.
- National Institute for Health and Care Excellence. Transvaginal meshes for anterior and posterior prolapse. 2017Link provided by the sponsor.
Related trials for Prolapse, Vaginal
Recruiting
The AMPER Study: Evaluation of the Efficacy of Human Amniotic Membrane Grafting in Preventing Mesh Exposure in Vaginal Reconstructive Surgery Using Polypropylene Mesh.
Pelvic Organ Prolapse Vaginal Surgery, Stress Urinary Incontinence in Women
Not yet recruitingObservational study
Urinary Continence After Vaginal Surgery for Genital Prolapse in the Spanish Population.
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Recruiting
BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
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The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
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Accelerometer Measured Early Recovery After Prolapse Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
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.