NCT04144829

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Intima Clinic · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	HIFU	Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
PROCEDURE	Fibrin	Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-08-01
• Completion: 2021-08-01
• First posted: 2019-10-30
• Last updated: 2019-11-05

Locations

1 site across 1 country: Poland