Clinical trial NCT02642835: A Long Term Follow up of Anterior Meshes for Recurrent Prolapse
Official title: A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genital Diseases, Female
Pelvic Organ Prolapse
Keywords: mesh
pelvic organ prolapse
Lead sponsor: Medway NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients having previously undergone a mesh repair

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.

Eligibility criteria: Inclusion Criteria:

* Women undergoing a perigee procedure after January 2007

Exclusion Criteria:

* Patient having non mesh repairs over the same time scale

Primary outcomes:
measure: The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
timeFrame: 1 hour
measure: Number of Participants Complaining of a Bulge. Recurrent Prolapse
timeFrame: 1 hour
measure: Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina
timeFrame: 1 hour
measure: Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment
timeFrame: 1 hour
measure: Number of Participants Who Developed New Stress Incontinence
timeFrame: 1 hour
measure: Number of Participants Who Rated Their Improvement as Better or Very Much Better
timeFrame: 1 hour
measure: Number of Participants Who Needed Surgical Mesh Removal for Erosion
timeFrame: 1 hour
measure: Number of Participants Who Needed Reoperations for Pain
timeFrame: 1 hour
measure: Number of Participants Who Experienced Intraoperative Complications
timeFrame: 1 hour
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation trust
state: Kent
Study officials:
affiliation: Medway NHS Foundation Trust
name: Jonathan Duckett, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: