Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

pfm medical gmbh292 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

292

Conditions

Cystocele Uterine Prolapse

Interventions

surgical mesh implantation (TiLOOP® Total 6)DEVICE

The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Berliner Kontinenzzentrum am Franziskus Krankenhaus,

Berlin, Germany

Krankenhaus Dresden- Friedrichsstadt

Dresden, Germany

Evangelisches Diakoniekrankenhaus Freiburg

Freiburg im Breisgau, Germany

Universitätsklinikum Eppendorf

Outcomes

Primary Outcomes

Erosion rate

Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.

Time frame: 12 months

Patient's quality of life

It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.

Time frame: 6 months

Secondary Outcomes

Adverse Events

Documentation and independent evaluation of all complications.

Time frame: at 6, 12, 36 months

Feasibility of the mesh implantation

Evaluation of questions on usability.

Time frame: 6 months

Erosion rate

Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.

Time frame: 36 months

Patient's quality of life

It will be shown that by means of a validated questionnaire whether the subjective quality of life after 6 months is significantly better than before implantation.

Time frame: 12 and 36 months

Data from ClinicalTrials.gov

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