Clinical trial NCT01084889: Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
Official title: National, Multicentre Post-marketing Surveillance Study on Anterior Pelvic Prolapse Reconstruction With Titanium-coated Polypropylene Mesh (TiLOOP® Total 6)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystocele
Uterine Prolapse
Keywords: polypropylene mesh
Prolapse
Cystocele
Surgical Mesh
Lead sponsor: pfm medical gmbh
Sponsor class: INDUSTRY
Collaborators: name: Aix Scientifics
name: GfE Medizintechnik GmbH
name: pfm medical titanium gmbh
name: Bayes GmbH
name: Crolll Gmbh
First posted: 2010-03-11
Enrollment: 292
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with a symptomatic genital descensus treated in the center

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.

Eligibility 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.

Primary outcomes:
measure: Erosion rate
timeFrame: 12 months
measure: Patient's quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: at 6, 12, 36 months
measure: Feasibility of the mesh implantation
timeFrame: 6 months
measure: Erosion rate
timeFrame: 36 months
measure: Patient's quality of life
timeFrame: 12 and 36 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Berliner Kontinenzzentrum am Franziskus Krankenhaus,
city: Dresden
country: Germany
facility: Krankenhaus Dresden- Friedrichsstadt
city: Freiburg
country: Germany
facility: Evangelisches Diakoniekrankenhaus Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Eppendorf
city: Leipzig
country: Germany
facility: St. Elisabeth Krankenhaus Leipzig,
city: Ludwigsburg
country: Germany
facility: Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg
city: München
country: Germany
facility: Beckenbodenzentrum München
city: Tettnang
country: Germany
facility: Klinik Tettnang GmbH
city: Zittau
country: Germany
facility: Klinikum Oberlausitzer Bergland gGmbH,
Study officials:
affiliation: Klinik Tettnang GmbH, Tettnang
name: Christian Fünfgeld, Dr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Funfgeld 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.