Genital Diseases, Female, Pelvic Organ Prolapse
Conditions
Keywords
mesh, pelvic organ prolapse
Brief 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. 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.
Interventions
PROCEDUREvaginal wall mesh
retrospective review of case series
Sponsors
Medway NHS Foundation Trust
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing a perigee procedure after January 2007
Exclusion criteria
* Patient having non mesh repairs over the same time scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted | 1 hour | clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Complaining of a Bulge. Recurrent Prolapse | 1 hour | 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 |
| Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina | 1 hour | clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment |
| Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment | 1 hour | 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. |
| Number of Participants Who Developed New Stress Incontinence | 1 hour | The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit |
| Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination | 1 hour | 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. |
| Number of Participants Who Needed Surgical Mesh Removal for Erosion | 1 hour | 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 |
| Number of Participants Who Needed Reoperations for Pain | 1 hour | patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit |
| Number of Participants Who Experienced Intraoperative Complications | 1 hour | This records any problems that were encountered at the original insertion of the mesh. clinic visit |
| Number of Participants Who Rated Their Improvement as Better or Very Much Better | 1 hour | 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 |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mesh Group underwent anterior mesh for recurrent cystocele | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Mesh Group |
|---|---|
| Age, Continuous | 66 years |
| BMI | 27.4 wt kg/ht m squared |
| Parity | 2 vaginal deliveries past 28 weeks |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
| time to follow up (months) | 82 number of months |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
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.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted | 5 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Complaining of a Bulge. Recurrent Prolapse | 14 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina | 1 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Developed New Stress Incontinence | 5 Participants |
Secondary
Number of Participants Who Experienced Intraoperative Complications
This records any problems that were encountered at the original insertion of the mesh. clinic visit
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Experienced Intraoperative Complications | 0 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Needed Reoperations for Pain | 3 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Needed Surgical Mesh Removal for Erosion | 2 Participants |
Secondary
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
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Rated Their Improvement as Better or Very Much Better | 33 Participants |
Secondary
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.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment | 8 Participants |
Secondary
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.
Time frame: 1 hour
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mesh Group | Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination | 26 Participants |