Genital Diseases, FemaleNCT02642835
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
An observational study of Genital Diseases, Female and Pelvic Organ Prolapse, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Genital Diseases, Female, Pelvic Organ Prolapse
- What is being tested?
- vaginal wall mesh
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients having previously undergone a mesh repair
Who may be able to join
- Women undergoing a perigee procedure after January 2007
Who cannot join
- Patient having non mesh repairs over the same time scale
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medway NHS Foundation trust
Gillingham, Kent, ME5 7NY
About this study
Official title: A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse
Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.
Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.
Read the detailed description
This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.
After obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.
- Conditions
- Genital Diseases, Female, Pelvic Organ Prolapse
- Being tested
- vaginal wall mesh
- Keywords
- mesh, pelvic organ prolapse
- Medical subject headings
- Genital Diseases, Female, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginal wall meshProcedure or surgery
retrospective review of case series
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.
Measured: 1 hour
Secondary outcomes (9)
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.
A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.
Measured: 1 hour
Number of Participants Complaining of a Bulge. Recurrent Prolapse
Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning
Measured: 1 hour
Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina
clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment
Measured: 1 hour
Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment
This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.
Measured: 1 hour
Number of Participants Who Developed New Stress Incontinence
The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit
Measured: 1 hour
Number of Participants Who Rated Their Improvement as Better or Very Much Better
The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit
Measured: 1 hour
Number of Participants Who Needed Surgical Mesh Removal for Erosion
A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit
Measured: 1 hour
Number of Participants Who Needed Reoperations for Pain
patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit
Measured: 1 hour
Number of Participants Who Experienced Intraoperative Complications
This records any problems that were encountered at the original insertion of the mesh. clinic visit
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genital Diseases, FemaleStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jonathan Duckett, Medway NHS Foundation Trust
- Investigators
- Jonathan Duckett, FRCOG, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642835
- Sponsor's protocol ID
- 9/12/14
- Status last verified
- Mar 2016
- First submitted
- 27 Aug 2015
- Last updated
- 29 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse
- ClinicalTrials.gov ID
- NCT02642835
- Acronym / sponsor ID
- 9/12/14
- Conditions
- Genital Diseases, Female, Pelvic Organ Prolapse
- Keywords
- mesh, pelvic organ prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 29 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.
Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.
Detailed description
This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.
After obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients having previously undergone a mesh repair
Key inclusion criteria (1 listed)
- Women undergoing a perigee procedure after January 2007
Key exclusion criteria (1 listed)
- Patient having non mesh repairs over the same time scale
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 |
|---|---|---|
| vaginal wall meshretrospective review of case series | Procedure or surgery | – |
Primary outcome
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
Time frame: 1 hour
clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.
9 secondary outcomes
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
Time frame: 1 hour
Number of Participants Complaining of a Bulge. Recurrent Prolapse
Time frame: 1 hour
Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina
Time frame: 1 hour
Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment
Time frame: 1 hour
Number of Participants Who Developed New Stress Incontinence
Time frame: 1 hour
Number of Participants Who Rated Their Improvement as Better or Very Much Better
Time frame: 1 hour
Number of Participants Who Needed Surgical Mesh Removal for Erosion
Time frame: 1 hour
Number of Participants Who Needed Reoperations for Pain
Time frame: 1 hour
Number of Participants Who Experienced Intraoperative Complications
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan Duckett, FRCOG principal investigator
Medway NHS Foundation Trust
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 Genital Diseases, Female and Pelvic Organ Prolapse, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 May 2018. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 29 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2018.