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

Primary Purpose

Stress Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
HIFU
Fibrin
Sponsored by
Intima Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Intima ClincRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HIFU

Fibrin

Arm Description

3 cycles of HIFU treatment in 6-week intervals

3 cycles of platelet-rich fibrin injection treatment in 6-week intervals

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 27, 2019
Last Updated
November 1, 2019
Sponsor
Intima Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04144829
Brief Title
Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
Official Title
Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intima Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HIFU
Arm Type
Active Comparator
Arm Description
3 cycles of HIFU treatment in 6-week intervals
Arm Title
Fibrin
Arm Type
Active Comparator
Arm Description
3 cycles of platelet-rich fibrin injection treatment in 6-week intervals
Intervention Type
Procedure
Intervention Name(s)
HIFU
Intervention Description
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
Intervention Type
Procedure
Intervention Name(s)
Fibrin
Intervention Description
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
Primary Outcome Measure Information:
Title
Improvement of patient's comfort and satisfaction
Description
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.
Time Frame
1 year
Title
Improvement of patient's comfort and satisfaction
Description
Improvement of patient's comfort and satisfaction measured in questionnaire FSFI (Female Sexual Function Index), score 2-36, higher score meaning better outcome
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Basta, PhD
Phone
501295424
Email
tomaszbasta@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Horbaczewska, MD
Phone
603307027
Email
anna.horbaczewska@yahoo.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Basta, PhD
Organizational Affiliation
Intima Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intima Clinc
City
Krakow
State/Province
Malopolskie Voivodeship
ZIP/Postal Code
31-559
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Basta, PhD
Phone
501295424
Ext
0048
Email
tomaszbasta@gmail.com
First Name & Middle Initial & Last Name & Degree
Anna Horbaczewska, MD
Phone
603307027
Ext
0048
Email
anna.horbaczewska@yahoo.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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