Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006516

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00006516
  •   2015/03/13
  •   2010/03/10
  •   no
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Secondary IDs

  •   NCT01084889  (ClinicalTrials.gov)
  •   pfm 10k001 TiLOOP® Total 6  (pfm medical ag)
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Health Condition or Problem studied

  •   Cystocele
  •   Uterine Prolapse
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Interventions/Observational Groups

  •   Device: TiLOOP® Total 6 (Surgical mesh implantation)
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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.
- 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.

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Secondary Outcome

- Adverse Events; time frame: at 6, 12, 36 months
- Feasibility of the mesh implantation; time frame: 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.
- 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.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2010/04/30
  •   290
  •   Multicenter trial
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional 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.

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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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • pfm medical ag
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    • Aix Scientifics
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    • GfE Medizintechnik GmbH
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    • Waldburg-Zeil Kliniken
    • Christian Fünfgeld, Dr. MD 
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    • Waldburg-Zeil Kliniken
    • Christian Fünfgeld, Dr. MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.