Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
NCT ID: NCT01358214
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
21 participants
OBSERVATIONAL
2011-05-31
2012-02-29
Brief Summary
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Detailed Description
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In the present study the patients' Quality of Life will be assessed by use of two questionnaires, that is a new one and an already validated questionnaire. The study population consists of patients who already received an implantation of a sub-urethral surgical mesh (TiLOOP® Tape), of symptomatic patients before an operation, and of a group of non-symptomatic women. Subjects will be asked in a single visit only to fill in both questionnaires.
Furthermore the safety and effectiveness of the TiLOOP® Tape mesh will be evaluated in the study arm of treated patients.
Study has been terminated after major recruitment failure (only 21 instead of 240 patients has been included).
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients treated with a surgical mesh
This arm of study patients is defined by patients treated with a TiLOOP® Tape mesh between 2007 and 2009 at the Franziskus Krankenhaus, Berlin. The sample of the treated population represents the patient population for which the medical device is intended. To minimize selection bias without compromising patients' rights and welfare, all treated patients will be invited. These patients will be asked to participate in the validation of the questionnaire on quality of life. In addition to this safety and effectiveness of the surgical mesh implantation will be collected
Questionnaire on Quality of Life.
The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
Intended to be treated with a mesh
This arm of the study populations is defined by patients in whom a clinical anamnesis independent of the requirements of this study suggests that a sub-urethral sling operation is indicated. These patients will be asked to participate in the validation of the questionnaire on quality of life.
Questionnaire on Quality of Life.
The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
Non-symptomatic Population
This arm of the study population is defined by women that show no symptoms of incontinence. They will be asked to participate in the validation of the questionnaire on quality of life.
Questionnaire on Quality of Life.
The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
Interventions
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Questionnaire on Quality of Life.
The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women with a TiLOOP® Tape implant, Implanted between 2007 and 2009 at the study center - OR -
* Woman with a planned Tape implantation at the study center - OR -
* Woman with no disease related to incontinence
* Subject is able to understand the nature, relevance and significance of the clinical trial
* Subject has given informed consent
Exclusion Criteria
* Lack of subject's compliance regarding data collection or examination in the scope of the trial (Non-Compliance)
* Subject institutionalized by court or official order (MPG §20.3)
* Subject participates in another clinical investigation
FEMALE
Yes
Sponsors
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Aix Scientifics
INDUSTRY
pfm medical gmbh
INDUSTRY
Responsible Party
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Principal Investigators
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Manfred Beer, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Locations
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Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Berlin, , Germany
Countries
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Related Links
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Other Identifiers
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pfm 10k003 TiLOOP® Tape
Identifier Type: -
Identifier Source: org_study_id