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

Not Applicable

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: HIFU; Procedure: Fibrin

• Registration Number: NCT04144829
• Lead Sponsor: Intima Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-29
• Study First Posted: 2019-10-30
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05
• Primary Completion: 2020-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIFU	HIFU	3 cycles of HIFU treatment in 6-week intervals
Fibrin	Fibrin	3 cycles of platelet-rich fibrin injection treatment in 6-week intervals

Primary Outcome Measures

Name	Time	Method
Improvement of patient's comfort and satisfaction	1 year	Improvement of patient's comfort and satisfaction measured in questionnaire FSFI (Female Sexual Function Index), score 2-36, higher score meaning better outcome

Trial Locations

Locations (1)

Intima Clinc; 🇵🇱 Krakow, Malopolskie Voivodeship, Poland