A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Condition: Genital Diseases, Female; Pelvic Organ Prolapse
MeSH terms: Genital Diseases; Genital Diseases, Female; Prolapse; Pelvic Organ Prolapse
Study type: Observational

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.
    

Intervention name(s): vaginal wall mesh
Intervention type(s): Procedure
Intervention description(s): retrospective review of case series
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients having previously undergone a mesh repair
      
Keywords: mesh; pelvic organ prolapse