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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFU | Active Comparator | 3 cycles of HIFU treatment in 6-week intervals |
|
| Fibrin | Active Comparator | 3 cycles of platelet-rich fibrin injection treatment in 6-week intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIFU | Procedure | Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Basta, PhD | Contact | 501295424 | tomaszbasta@gmail.com | |
| Anna Horbaczewska, MD | Contact | 603307027 | anna.horbaczewska@yahoo.pl |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Basta, PhD | Intima Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intima Clinc | Recruiting | Krakow | Malopolskie Voivodeship | 31-559 | Poland |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D005337 | Fibrin |
| ID | Term |
|---|---|
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Fibrin | Procedure | Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |