Urinary Incontinence, Stress
Conditions
Keywords
Sub-urethral Sling, Treatment Outcome, Quality of Life
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.
Detailed description
The prevalence of urinary incontinence in the adult female population has been estimated between 10% and 40%. Several treatment alternatives have been suggested until now. Nevertheless, the ideal treatment has not been identified yet. On the one hand this is related to the low amount of valid scientific information regarding different treatment methods. On the other hand the impact of patients' quality of life, which plays a major role, has not been fully considered. To date, there is no established Questionnaire on Quality of Life that provides physicians an assistance to obtain information on the subjective effects caused by stress urinary incontinence. 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).
Interventions
BEHAVIORALQuestionnaire 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.
Sponsors
Aix Scientifics
pfm medical gmbh
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of a new questionnaire on quality of life | before treatment (baseline) or 6 to 24 months after treatment, respectively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of surgical mesh implantation for treatment of urinary incontinence | 6-24 months after treatment | In the study arm of treated patients the study outcome will describe all safety relevant events occurred within the period from implantation until scheduled study examination. The time between scheduled examination and implantation varies as the implantation it not part of this study. The findings will therefore be stratified by 6 months, 12 months and 24 months after implantation. |
| Effectiveness of surgical mesh implantation for treatment of urinary incontinence | 6-24 months after treatment | In the study arm of treated patients, the study outcome will describe the efficacy of the TiLOOP® Tape implantation based on successful implantation and complications observed during the period from implantation until discharge from the hospital. The time between scheduled examination and implantation varies as the implantation it not part of this study. The findings will therefore be stratified by 6 months, 12 months and 24 months after implantation. |
Countries
Germany
Outcome results
None listed