Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Procedure: HIFU
* Procedure: Fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: stress urinary incontinence of low grade separate episodes of urinary incontinence (associated with increase of abdominal pressure) no cystocoele or cystocoele POPQ1 positive cough test when filled bladder Exclusion Criteria: POPQ 2 and more patients after urogenital operations or radiation neuromuscular, hematologic, autoimmune, uncontrolled psychiatric diseases uncontrolled diabetes pregnancy, lactation patients undergoing conservative treatment for stress urinary incontinence ASA or other anti-platelet drug intake less than 7 days before and 7 days after procedure active carcinomas or status less than 5 years after treatment sepsis infection in treated region

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIFU<br>3 cycles of HIFU treatment in 6-week intervals | Procedure: HIFU<br>* Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively<br>|
| Active Comparator: Fibrin<br>3 cycles of platelet-rich fibrin injection treatment in 6-week intervals | Procedure: Fibrin<br>* Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement 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. | 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 | 1 year |