Urinary Incontinence, Stress Clinical Trial
Official title:
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)
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.
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).
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Observational Model: Case Control, Time Perspective: Cross-Sectional
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