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

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04144829
• Other study ID #: Intima1/2019
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: November 2019
• Source: Intima Clinic
• Contact: Tomasz Basta, PhD
• Phone: 501295424
• Email: tomaszbasta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Poland	Intima Clinc	Krakow	Malopolskie Voivodeship

Sponsors (1)

Lead Sponsor	Collaborator
Intima Clinic

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of patient's comfort and satisfaction	Improvement 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.	1 year
Primary	Improvement of patient's comfort and satisfaction	Improvement of patient's comfort and satisfaction measured in questionnaire FSFI (Female Sexual Function Index), score 2-36, higher score meaning better outcome	1 year