Stress Urinary IncontinenceNCT04144829
Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
A study testing HIFU and Fibrin in people with Stress Urinary Incontinence, run by Intima Clinic at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- HIFU and Fibrin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 1 Aug 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Intima Clinc
Krakow, Malopolskie Voivodeship, 31-559
Tomasz Basta, PhD, 501295424 ext. 0048, tomaszbasta@gmail.com
Anna Horbaczewska, MD, 603307027 ext. 0048, anna.horbaczewska@yahoo.pl
About this study
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.
Read more
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.
- Conditions
- Stress Urinary Incontinence
- Being tested
- HIFU, Fibrin
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFUProcedure or surgery
Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
FibrinProcedure or surgery
Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
| Study group | Role | What they receive |
|---|---|---|
| HIFU | Active comparator | 3 cycles of HIFU treatment in 6-week intervals Receives: Procedure: HIFU |
| Fibrin | Active comparator | 3 cycles of platelet-rich fibrin injection treatment in 6-week intervals Receives: Procedure: Fibrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start1 Aug 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intima Clinic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Tomasz Basta, Intima Clinic
- Investigators
- Tomasz Basta, PhD, Principal investigator, Intima Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144829
- Sponsor's protocol ID
- Intima1/2019
- Status last verified
- Nov 2019
- First submitted
- 27 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-rich Fibrin Versus HIFU in Management of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04144829
- Acronym / sponsor ID
- Intima1/2019
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Intima ClinicIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIFU | Active comparator | Procedure: HIFU3 cycles of HIFU treatment in 6-week intervals |
| Fibrin | Active comparator | Procedure: Fibrin3 cycles of platelet-rich fibrin injection treatment in 6-week intervals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- POPQ 2 and more
- patients after urogenital operations or radiation
- neuromuscular, hematologic, autoimmune, uncontrolled psychiatric diseases
- uncontrolled diabetes
- pregnancy, lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIFUIntravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively | Procedure or surgery | HIFU |
| FibrinInjection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra | Procedure or surgery | Fibrin |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Basta, PhD principal investigator
Intima Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIFU and Fibrin in people with Stress Urinary Incontinence, run by Intima Clinic at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tomasz Basta, PhD (501295424, tomaszbasta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of patient's comfort and satisfaction (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2019.