Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

pfm medical

Status: Completed

Conditions: Uterine Prolapse; Cystocele

Treatments: Device: surgical mesh implantation (TiLOOP® Total 6)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01084889

pfm 10k001 TiLOOP® Total 6

Details and patient eligibility

About

The purpose of this study is to determine the influence of Anterior Pelvic Prolapse Reconstruction with a titanised polypropylene mesh on rate of erosion and patients quality of live.

Full description

This multicentre, non-randomised, observational clinical device investigation will be performed to obtain post-marketing information on the TiLOOP® pelvic floor reconstruction meshes and in particular on the rate of rare erosions of the device under investigation as well as on the improvement of patients' quality of life. It is expected that the rate of erosions is equal or lower compared to competitor devices currently on the market. To verify this, it will be shown that within the first year the erosion rate found for the product under investigation is in the range of 7.9 ± 5.4 %, which is the mean erosion rate found in the recent literature. Erosion, in the sense of the hypothesis, is any erosion 1 requiring more than simply the cut off of a single short filament.

It is also expected that the patient's quality of life is meliorated after implantation of a TiLOOP® Total 6 mesh. To verify this, it will be shown that by means of a validated questionnaire the subjective quality of life after 6 months is significantly better than before implantation.

Enrollment: 292 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention. This applies to primary as well as recurrent intervention
• Existence of a cystocele.
• Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation
• Patient information has been handed out and all written consents are at hand.
• Patient has attained full age.

Exclusion criteria

• Pregnancy or unfinished family planning.
• Known intolerance to the mesh-implants under investigation.
• Patients with acute (last 12 months) carcinoma.
• Patients with history of radiotherapy in the pelvic area.
• Genital descensus without any complaints.
• Patients with implanted pelvic floor mesh.
• Systemic steroid treatment.
• Lack of written patients' informed consent.
• Lack of patient compliance regarding data collection, treatment or follow-up investigations in the scope of the protocol.
• Patient is institutionalised by court or official order (MPG §20.3).
• Participation in another clinical investigation.

Trial design

292 participants in 1 patient group

symptomatic genital descensus

Description:

Women with a symptomatic genital descensus : at least stage II (ICS-classification according pelvic organ prolapse quanification (POP-Q) system), or stage I with a symptomatic requiring intervention. Standard method to implant the TiLOOP® Total 6 surgical mesh transvaginally.

Treatment:

Device: surgical mesh implantation (TiLOOP® Total 6)