N/A
N=48
A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Genital Diseases, Female · Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT02642835 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
May 2018
Primary outcome: Primary: The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted — 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- vaginal wall mesh (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Medway NHS Foundation Trust
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted |
5 | — |
| SECONDARY Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination |
26 | — |
| SECONDARY Number of Participants Complaining of a Bulge. Recurrent Prolapse |
14 | — |
| SECONDARY Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina |
1 | — |
| SECONDARY Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment |
8 | — |
| SECONDARY Number of Participants Who Developed New Stress Incontinence |
5 | — |
| SECONDARY Number of Participants Who Rated Their Improvement as Better or Very Much Better |
33 | — |
| SECONDARY Number of Participants Who Needed Surgical Mesh Removal for Erosion |
2 | — |
| SECONDARY Number of Participants Who Needed Reoperations for Pain |
3 | — |
| SECONDARY Number of Participants Who Experienced Intraoperative Complications |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women undergoing a perigee procedure after January 2007
Exclusion Criteria
- Patient having non mesh repairs over the same time scale
Data sourced from ClinicalTrials.gov (NCT02642835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.