VESPER: Stress Urinary Incontinence STUDY (NCT03996070) | Clinical Trial Compass
CompletedNot Applicable
VESPER: Stress Urinary Incontinence STUDY
United Kingdom30 participantsStarted 2022-06-06
Plain-language summary
Patients seen with stress urinary incontinence (SUI) that have failed conservative treatments will be offered to participate in a sham controlled RCT of outpatient therapy with the Fotona Smooth Erbium Yag laser. Patients will be randomised to either outpatient laser treatments or sham treatments. Patients will be blinded to which arm they have been randomised. Patients will be asked to complete appropriate relevant symptom and quality of life questionnaires prior to treatment and then at 6 and 12 months following the final treatment. At 6 months Sham patients will be un-blinded and offered the laser therapy if they wish.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Adult Female, 18 years of age or older
✓. Clinical and UDS diagnosis of Stress Urinary Incontinence
✓. SUI on 1-hour Pad weight test between 2g and 25g (SUI I: 2-10g, SUI II:11-25g)
✓. No significant improvement in urinary incontinence from at least one previous conservative treatment, such as pelvic floor muscle training
Exclusion criteria
✕. Pre-existing bladder pathology including prior radiation treatment
✕. Pregnancy
✕. BMI\>35
✕. Radical pelvic surgery or previous incontinence surgery
✕. Urinary tract infection or other active infections of urinary tract or bladder
✕. SUI on 1 hour pad weight test \>25g (SUI III: \>25g)