Study Stopped
major recruitment failure
Quality of Life After Tension Free Transvaginal Sling / Tape Operation With a Titanized Surgical Tape (TiLOOP® Tape)
Single-center, Non-randomized, Comparative, Post-marketing Surveillance Cohort Study on Validation of a Questionnaire on Quality of Life After Surgical Stabilization of the Urethra With Titanized Polypropylene Mesh (TiLOOP® Tape)
1 other identifier
observational
21
1 country
1
Brief Summary
Validation of a new Quality of Life (QoL) questionnaire in a population of patient gaining a TiLOOP® TAPE surgical mesh for stabilization of the urethra.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedAugust 23, 2012
August 1, 2012
9 months
May 18, 2011
August 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Validation of a new questionnaire on quality of life
It is expected that the newly developed questionnaire on quality of life (QoL) is equal or better in description of the impact on QoL regarding the differentiation of the study populations, as compared to the standard questionnaire.
before treatment (baseline) or 6 to 24 months after treatment, respectively
Secondary Outcomes (2)
Safety of surgical mesh implantation for treatment of urinary incontinence
6-24 months after treatment
Effectiveness of surgical mesh implantation for treatment of urinary incontinence
6-24 months after treatment
Study Arms (3)
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
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.
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.
Interventions
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.
Eligibility Criteria
The indicated or treated population of women showing stress urinary incontinence that should / has been treated with a surgical mesh. The sample of patients treated with TiLOOP® Tape at the single center between 2007 and 2009 represents the patient population for which the medical device is intended. The clinic continues to examine women with incontinence symptoms requiring a mesh implant. This group of patients is assumed to be similar to the study arm of treated patients. The Non-symptomatic Population consists of women comparable in age but without urinary incontinence
You may qualify if:
- Depending on study arm:
- 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
You may not qualify if:
- Subject revoked consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- pfm medical gmbhlead
- Aix Scientificscollaborator
Study Sites (1)
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Berlin, 10787, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manfred Beer, Prof. MD
Franziskus-Krankenhaus Berlin Akademisches Lehrkrankenhaus der Charité - Universtätsmedizin Berlin
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 23, 2011
Study Start
May 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
August 23, 2012
Record last verified: 2012-08