Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

January 31, 2019 updated by: pfm medical ag

National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10787
        • Berliner Kontinenzzentrum am Franziskus Krankenhaus,
      • Dresden, Germany, 01067
        • Krankenhaus Dresden- Friedrichsstadt
      • Freiburg, Germany
        • Evangelisches Diakoniekrankenhaus Freiburg
      • Hamburg, Germany, 20246
        • Universitätsklinikum Eppendorf
      • Leipzig, Germany, 04277
        • St. Elisabeth Krankenhaus Leipzig,
      • Ludwigsburg, Germany, 71640
        • Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg
      • München, Germany, 81679
        • Beckenbodenzentrum München
      • Tettnang, Germany, 88069
        • Klinik Tettnang GmbH
      • Zittau, Germany, 02763
        • Klinikum Oberlausitzer Bergland gGmbH,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a symptomatic genital descensus treated in the center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptomatic genital descensus

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.
Device: surgical mesh implantation (TiLOOP® Total 6)
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.
Other Names:
  • TiLOOP® Total 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Erosion rate
Time Frame: 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.
12 months
Patient's quality of life
Time Frame: 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: at 6, 12, 36 months
Documentation and independent evaluation of all complications.
at 6, 12, 36 months
Feasibility of the mesh implantation
Time Frame: 6 months
Evaluation of questions on usability.
6 months
Erosion rate
Time Frame: 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.
36 months
Patient's quality of life
Time Frame: 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.
12 and 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

pfm medical ag

Collaborators

Aix Scientifics
Crolll Gmbh
Bayes GmbH
GfE Medizintechnik GmbH
pfm medical titanium gmbh

Investigators

  • Principal Investigator: Christian Fünfgeld, Dr. MD, Klinik Tettnang GmbH, Tettnang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pfm 10k001 TiLOOP® Total 6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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