Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Cystocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01084889
• Other study ID #: pfm 10k001 TiLOOP® Total 6
• Status: Completed
• Start date: April 2010
• Est. completion date: June 2016

Study information

• Verified date: January 2019
• Source: pfm medical ag
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: June 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystocele
• Prolapse
• Uterine Prolapse

Intervention

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.

Locations

Country	Name	City	State
Germany	Berliner Kontinenzzentrum am Franziskus Krankenhaus,	Berlin
Germany	Krankenhaus Dresden- Friedrichsstadt	Dresden
Germany	Evangelisches Diakoniekrankenhaus Freiburg	Freiburg
Germany	Universitätsklinikum Eppendorf	Hamburg
Germany	St. Elisabeth Krankenhaus Leipzig,	Leipzig
Germany	Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg	Ludwigsburg
Germany	Beckenbodenzentrum München	München
Germany	Klinik Tettnang GmbH	Tettnang
Germany	Klinikum Oberlausitzer Bergland gGmbH,	Zittau

Sponsors (6)

Lead Sponsor	Collaborator
pfm medical ag	Aix Scientifics, Bayes GmbH, Crolll Gmbh, GfE Medizintechnik GmbH, pfm medical titanium gmbh

Country where clinical trial is conducted

Germany, 

References & 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 t — View Citation

Fünfgeld 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 Frauenhei — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adverse Events	Documentation and independent evaluation of all complications.	at 6, 12, 36 months
Secondary	Feasibility of the mesh implantation	Evaluation of questions on usability.	6 months
Secondary	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.	36 months
Secondary	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.	12 and 36 months

External Links

•   Quality of life and pelvic organ prolapse-related symptoms after pelvic floor reconstruction with a titanized polypropylene mesh for cystocele: long-term results in a 36 month follow-up by Fünfgeld et al, 2018