NCT04144829

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

October 27, 2019

Last Update Submit

November 1, 2019

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

HIFU

ACTIVE COMPARATOR

3 cycles of HIFU treatment in 6-week intervals

Procedure: HIFU

Fibrin

ACTIVE COMPARATOR

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

Procedure: Fibrin

Interventions

HIFUPROCEDURE

Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively

HIFU
FibrinPROCEDURE

Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra

Fibrin

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intima Clinc

Krakow, Malopolskie Voivodeship, 31-559, Poland

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Fibrin

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Tomasz Basta, PhD

    Intima Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Basta, PhD

CONTACT

501295424tomaszbasta@gmail.com

Anna Horbaczewska, MD

CONTACT

603307027anna.horbaczewska@yahoo.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2019

First Posted

October 30, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2020

Study Completion

August 1, 2021

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)