Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Completed

• Conditions: Uterine Prolapse; Cystocele
• Interventions: Device: surgical mesh implantation (TiLOOP® Total 6)

• Registration Number: NCT01084889
• Lead Sponsor: pfm medical gmbh

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Study Start: 2010-04
• Primary Completion: 2014-01
• Study Completion: 2016-06
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 292

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic genital descensus	surgical mesh implantation (TiLOOP® Total 6)	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.

Primary Outcome Measures

Name	Time	Method
Erosion rate	12 months	Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	at 6, 12, 36 months	Documentation and independent evaluation of all complications.
Feasibility of the mesh implantation	6 months	Evaluation of questions on usability.
Erosion rate	36 months	Erosion, in the sense of the end point, is any erosion requiring more than simply the cut off of a single short filament.
Patient's quality of life	12 and 36 months	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.

Trial Locations

Locations (9)

Universitätsklinikum Eppendorf; 🇩🇪 Hamburg, Germany

Klinik Tettnang GmbH; 🇩🇪 Tettnang, Germany

Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany

Beckenbodenzentrum München; 🇩🇪 München, Germany

Evangelisches Diakoniekrankenhaus Freiburg; 🇩🇪 Freiburg, Germany

Krankenhaus Dresden- Friedrichsstadt; 🇩🇪 Dresden, Germany

Berliner Kontinenzzentrum am Franziskus Krankenhaus,; 🇩🇪 Berlin, Germany

Klinikum Oberlausitzer Bergland gGmbH,; 🇩🇪 Zittau, Germany

St. Elisabeth Krankenhaus Leipzig,; 🇩🇪 Leipzig, Germany