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

Intima Clinic

Status: Unknown

Conditions: Stress Urinary Incontinence

Treatments: Procedure: HIFU; Procedure: Fibrin

Study type: Interventional

Funder types: Industry

Identifiers

NCT04144829

Intima1/2019

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

HIFU

Active Comparator group

Description:

3 cycles of HIFU treatment in 6-week intervals

Treatment:

Procedure: HIFU

Fibrin

Active Comparator group

Description:

3 cycles of platelet-rich fibrin injection treatment in 6-week intervals

Treatment:

Procedure: Fibrin