A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

NCT ID: NCT02642835

Last Updated: 2018-05-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 48 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-03-31

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.

Conditions

Genital Diseases, Female; Pelvic Organ Prolapse

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

vaginal wall mesh

retrospective review of case series

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women undergoing a perigee procedure after January 2007

Exclusion Criteria

• Patient having non mesh repairs over the same time scale

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medway NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Professor Jonathan Duckett

Consultant Urogynaecologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Duckett, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Medway NHS Foundation Trust

Locations

Medway NHS Foundation trust

Gillingham, Kent, United Kingdom

Countries

United Kingdom

Other Identifiers

9/12/14

Identifier Type: -

Identifier Source: org_study_id