A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

NCT02642835 | Completed Results

• 1 other identifier: 9/12/14
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Genital Diseases, Female; Pelvic Organ Prolapse

Keywords

mesh; pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• 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.

  1 hour

Secondary Outcomes (9)

• Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination

  1 hour

• Number of Participants Complaining of a Bulge. Recurrent Prolapse

  1 hour

• Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina

  1 hour

• Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment

  1 hour

• Number of Participants Who Developed New Stress Incontinence

  1 hour

Interventions

vaginal wall mesh PROCEDURE

retrospective review of case series

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients having previously undergone a mesh repair

You may qualify if:

• Women undergoing a perigee procedure after January 2007

You may not qualify if:

• Patient having non mesh repairs over the same time scale

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway NHS Foundation trust

Gillingham, Kent, ME5 7NY, United Kingdom

Location

MeSH Terms

Conditions

Genital Diseases, Female; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Jonaathan Duckett -Consultant Urogynaecologist
• Organization: Medway NHS Foundation Trust

jraduckett@hotmail.com

01634

Study Officials

• Jonathan Duckett, FRCOG

  Medway NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urogynaecologist

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: December 30, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 29, 2018
• Results First Posted: May 29, 2018

Record last verified: 2016-03

Locations

GB (1)