This is a prospective, randomized, controlled, two-armed multi-center pre-market trial. Nighty-six (96) subjects will be recruited at sites in Sweden. Patients with diagnosed stress urinary incontinence (SUI), will be considered as potential study participants. After written informed consent has been acquired, a medical and surgical history, a physical examination (including pelvic examination), and a confirmation of the diagnosis of SUI will be performed, followed by a confirmation of the inclusion/exclusion criteria. The study subjects fulfilling all the eligibility criteria will thereafter be randomized 3:1 into either the TVS group or the standard of care (SoC) group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
97
Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.
Ladulaas Kliniska Studier
Borås, Sweden
Kvinnokliniken Karolinska Sjukhuset
Huddinge, Sweden
PTC-Skaraborg
Skövde, Sweden
PTC-Göteborg
Västra Frölunda, Sweden
Absolute reduction in leakage as measured by pad weight in gram
The primary endpoint will be the absolute reduction in pad weight from the run-in week (week 1) compared with the final week (week 3). The weight of the pad is defined as the mean weight over the entire week of measurement.
Time frame: 3 weeks
Success rate in % in reducing urinary leakage measured by pad weight
Overall success rate, defined as at least 70% reduction in pad weight measured in gram from run-in to the final week (week 3).
Time frame: 3 weeks
Reduction of urinary leakage episodes measured by subjective observations
Reduction of SUI episodes from the run-in week compared to the final week (week 3) by entry of subjective observations in study diary.
Time frame: 3 weeks
General impact on quality of life parameters
General impact on quality of life parameters using European Quality of Life - 5 dimensions (EQ-5D-5L) comparing week 1 and week 3.
Time frame: 3 weeks
Impact on disease specific qulity of life parameters
Disease specific Impact of Quality of life parameters, measured by the Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory (UDI-6) comparing week 1 and week.
Time frame: 3 weeks
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