Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)
1 other identifier
observational
292
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2010
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2010
CompletedFirst Posted
Study publicly available on registry
March 11, 2010
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 4, 2019
January 1, 2019
3.8 years
March 10, 2010
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
6 months
Secondary Outcomes (4)
Adverse Events
at 6, 12, 36 months
Feasibility of the mesh implantation
6 months
Erosion rate
36 months
Patient's quality of life
12 and 36 months
Study Arms (1)
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.
Interventions
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 Criteria
Women with a symptomatic genital descensus treated in the center
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pfm medical gmbhlead
- Aix Scientificscollaborator
- GfE Medizintechnik GmbHcollaborator
- pfm medical titanium gmbhcollaborator
- Bayes GmbHcollaborator
- Crolll Gmbhcollaborator
Study Sites (9)
Berliner Kontinenzzentrum am Franziskus Krankenhaus,
Berlin, 10787, Germany
Krankenhaus Dresden- Friedrichsstadt
Dresden, 01067, Germany
Evangelisches Diakoniekrankenhaus Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Eppendorf
Hamburg, 20246, Germany
St. Elisabeth Krankenhaus Leipzig,
Leipzig, 04277, Germany
Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg
Ludwigsburg, 71640, Germany
Beckenbodenzentrum München
München, 81679, Germany
Klinik Tettnang GmbH
Tettnang, 88069, Germany
Klinikum Oberlausitzer Bergland gGmbH,
Zittau, 02763, Germany
Related Publications (2)
Farthmann J, Mengel M, Henne B, Grebe M, Watermann D, Kaufhold J, Stehle M, Fuenfgeld C. Improvement of pelvic floor-related quality of life and sexual function after vaginal mesh implantation for cystocele: primary endpoint of a prospective multicentre trial. Arch Gynecol Obstet. 2016 Jul;294(1):115-21. doi: 10.1007/s00404-016-4014-0. Epub 2016 Jan 18.
PMID: 26781262RESULTFunfgeld C, Stehle M, Henne B, Kaufhold J, Watermann D, Grebe M, Mengel M. Quality of Life, Sexuality, Anatomical Results and Side-effects of Implantation of an Alloplastic Mesh for Cystocele Correction at Follow-up after 36 Months. Geburtshilfe Frauenheilkd. 2017 Sep;77(9):993-1001. doi: 10.1055/s-0043-116857. Epub 2017 Sep 25.
PMID: 28959063RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Fünfgeld, Dr. MD
Klinik Tettnang GmbH, Tettnang
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2010
First Posted
March 11, 2010
Study Start
April 1, 2010
Primary Completion
January 1, 2014
Study Completion
June 1, 2016
Last Updated
February 4, 2019
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will not share