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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04144829
Enrollment
200
Registered
2019-10-30
Start date
2019-08-01
Completion date
2021-08-01
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Urinary Incontinence

Brief summary

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.

Interventions

PROCEDUREHIFU

Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively

PROCEDUREFibrin

Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra

Sponsors

Intima Clinic
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement of patient's comfort and satisfaction1 yearImprovement 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.

Countries

Poland

Contacts

Primary ContactTomasz Basta, PhD
tomaszbasta@gmail.com501295424
Backup ContactAnna Horbaczewska, MD
anna.horbaczewska@yahoo.pl603307027

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026