Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6

Sponsor

pfm medical ag (Industry)

Overall Status

Completed

CT.gov ID

NCT01084889

Collaborator

Aix Scientifics (Industry), GfE Medizintechnik GmbH (Other), pfm medical titanium gmbh (Other), Bayes GmbH (Other), Crolll Gmbh (Other)

292

Enrollment

Locations

Actual Duration (Months)

32.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystocele Uterine Prolapse	Device: surgical mesh implantation (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.

Study Design

Study Type:

Observational

Actual Enrollment :

292 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.	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. Other Names: TiLOOP® Total 6

Arm

Intervention/Treatment

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.

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.

Other Names:

TiLOOP® Total 6

Outcome Measures

Primary Outcome Measures

Erosion rate [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 [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.

Secondary Outcome Measures

Adverse Events [at 6, 12, 36 months]
Documentation and independent evaluation of all complications.
Feasibility of the mesh implantation [6 months]
Evaluation of questions on usability.
Erosion rate [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Berliner Kontinenzzentrum am Franziskus Krankenhaus,	Berlin	Germany	10787
2	Krankenhaus Dresden- Friedrichsstadt	Dresden	Germany	01067
3	Evangelisches Diakoniekrankenhaus Freiburg	Freiburg	Germany
4	Universitätsklinikum Eppendorf	Hamburg	Germany	20246
5	St. Elisabeth Krankenhaus Leipzig,	Leipzig	Germany	04277
6	Regionale Kliniken Holding RKH GmbH, Klinikum Ludwigsburg	Ludwigsburg	Germany	71640
7	Beckenbodenzentrum München	München	Germany	81679
8	Klinik Tettnang GmbH	Tettnang	Germany	88069
9	Klinikum Oberlausitzer Bergland gGmbH,	Zittau	Germany	02763