Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
NCT ID: NCT04144829
Last Updated: 2019-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2019-08-01
2021-08-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HIFU
3 cycles of HIFU treatment in 6-week intervals
HIFU
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
Fibrin
3 cycles of platelet-rich fibrin injection treatment in 6-week intervals
Fibrin
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
Interventions
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HIFU
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
Fibrin
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
Eligibility Criteria
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Inclusion Criteria
* separate episodes of urinary incontinence (associated with increase of abdominal pressure)
* no cystocoele or cystocoele POPQ1
* positive cough test when filled bladder
Exclusion Criteria
* 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
18 Years
60 Years
FEMALE
No
Sponsors
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Intima Clinic
INDUSTRY
Responsible Party
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Tomasz Basta
Principal Investigator
Principal Investigators
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Tomasz Basta, PhD
Role: PRINCIPAL_INVESTIGATOR
Intima Clinic
Locations
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Intima Clinc
Krakow, Malopolskie Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Intima1/2019
Identifier Type: -
Identifier Source: org_study_id
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