Aim of the study is to compare effect of High Intensity Focused Ultrasound (HIFU) and platelet-rich fibrin in management of stress urinary incontinence. It is a randomized prospective study. After assigning to one of the two groups, patients will undergo relevant treatment. First group will undergo 3 cycles of intravaginal HIFU treatment in 6-weeks interval. Second group will undergo 3 injections of platelet-rich fibrin under urethra. Before the treatment and after 2, 6 and 12 months after treatment is finished patients will be asked to fill questionaries concerning quality of life ICIQ-UI SF, ICIQ-LUTS, PISQ12, FSFI. Before each treatment cycle patients will be examined and asked to fill daily micturition plan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
Intima Clinc
Krakow, Malopolskie Voivodeship, Poland
RECRUITINGImprovement of patient's comfort and satisfaction
Improvement of patient's comfort and satisfaction measured in questionnaire ICIQ-UI SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), scale 0-21 points, higher score meaning worse outcome.
Time frame: 1 year
Improvement of patient's comfort and satisfaction
Improvement of patient's comfort and satisfaction measured in questionnaire FSFI (Female Sexual Function Index), score 2-36, higher score meaning better outcome
Time frame: 1 year
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