CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
vaginal wall meshprocedure
Likely dose
Perigee anterior vaginal wall mesh procedureAI-extracted
Key inclusion· 1
  • Women who underwent Perigee procedure after January 2007
Key exclusion· 1
  • Patients who had non-mesh repairs during the same time period

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02642835
NCT02642835N/ACompleted

A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse

Medway NHS Foundation Trust·observational·Posted Dec 30, 2015·Updated May 29, 2018

In Brief

An observational study evaluating vaginal wall mesh for Genital Diseases, Female and Pelvic Organ Prolapse. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 30, 2015
Enrollment StartAug 1, 2015
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.5 years ago

Interventions

vaginal wall meshprocedure

retrospective review of case series