Anterior Pelvic Prolapse Reconstruction With TiLOOP® Total 6
This study is ongoing, but not recruiting participants.
Sponsor:
pfm medical ag
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
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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
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:
|
Cystocele Prolapse Uterine Prolapse Urinary Bladder Diseases Urologic Diseases |
Pelvic Organ Prolapse Pathological Conditions, Anatomical Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 17, 2013