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

Last updated: November 1, 2019
Sponsor: Intima Clinic
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT04144829
Intima1/2019
  • Ages 18-60
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • stress urinary incontinence of low grade

  • separate episodes of urinary incontinence (associated with increase of abdominalpressure)

  • no cystocoele or cystocoele POPQ1

  • positive cough test when filled bladder

Exclusion

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 afterprocedure

  • active carcinomas or status less than 5 years after treatment

  • sepsis

  • infection in treated region

Study Design

Total Participants: 200
Study Start date:
August 01, 2019
Estimated Completion Date:
August 01, 2021

Connect with a study center

  • Intima Clinc

    Krakow, Malopolskie Voivodeship 31-559
    Poland

    Active - Recruiting

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