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

November 1, 2019 updated by: Tomasz Basta, Intima Clinic

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolskie Voivodeship
      • Krakow, Malopolskie Voivodeship, Poland, 31-559

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HIFU
3 cycles of HIFU treatment in 6-week intervals
Procedure: HIFU
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
Active Comparator: Fibrin
3 cycles of platelet-rich fibrin injection treatment in 6-week intervals
Procedure: Fibrin
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of patient's comfort and satisfaction
Time Frame: 1 year
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
Improvement of patient's comfort and satisfaction
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intima Clinic

Investigators

  • Principal Investigator: Tomasz Basta, PhD, Intima Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

October 27, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Intima1/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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