Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aix Scientifics
GfE Medizintechnik GmbH
Information provided by (Responsible Party):
pfm medical ag
ClinicalTrials.gov Identifier:
NCT01084889
First received: March 10, 2010
Last updated: February 11, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention
Cystocele
Uterine Prolapse
Device: TiLOOP® Total 6 (Surgical mesh implantation)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)

Resource links provided by NLM:


Further study details as provided by pfm medical ag:

Primary Outcome Measures:
  • Erosion rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Adverse Events [ Time Frame: at 6, 12, 36 months ] [ Designated as safety issue: Yes ]
  • Feasibility of the mesh implantation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Erosion rate [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 290
Study Start Date: April 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
symptomatic genital descensus
Women with a symptomatic genital descensus : at least stage II (ICS-classification according POP-Q system), or stage I with a symptomatic requiring intervention.
Device: TiLOOP® Total 6 (Surgical mesh implantation)
The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans vaginal by the aid of surgical instruments to place the mesh arms.
Other Name: TiLOOP® Total 6

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with a symptomatic genital descensus treated in the center

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01084889

Locations
Germany
Berliner Kontinenzzentrum am Franziskus Krankenhaus,
Berlin, Germany, 10787
Krankenhaus Dresden- Friedrichsstadt
Dresden, Germany, 01067
Evangelisches Diakoniekrankenhaus Freiburg
Freiburg, Germany
Universitätsklinikum Eppendorf
Hamburg, Germany, 20246
St. Elisabeth Krankenhaus Leipzig,
Leipzig, Germany, 04277
Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg
Ludwigsburg, Germany, 71640
Beckenbodenzentrum München
München, Germany, 81679
Waldburg-Zeil Kliniken, Klinik Tettnang
Tettnang, Germany, 88069
Klinikum Oberlausitzer Bergland gGmbH,
Zittau, Germany, 02763
Sponsors and Collaborators
pfm medical ag
Aix Scientifics
GfE Medizintechnik GmbH
Investigators
Principal Investigator: Christian Fünfgeld, Dr. MD Waldburg-Zeil Kliniken
  More Information

No publications provided

Responsible Party: pfm medical ag
ClinicalTrials.gov Identifier: NCT01084889     History of Changes
Other Study ID Numbers: pfm 10k001 TiLOOP® Total 6
Study First Received: March 10, 2010
Last Updated: February 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by pfm medical ag:
polypropylene mesh
Prolapse
Cystocele
Surgical Mesh

Additional relevant MeSH terms:
Prolapse
Cystocele
Uterine Prolapse
Pathological Conditions, Anatomical
Urinary Bladder Diseases
Urologic Diseases
Pelvic Organ Prolapse
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014