Urinary IncontinenceNCT06691334
Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence (SUI): Pilot Study
A study testing PRP injection and Hifu procedure and PRP injection in people with Urinary Incontinence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI . This study add the effect both HIFU and PRP together in treating SUI. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- PRP injection and Hifu procedure and PRP injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 1 Mar 2023
- 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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women complain of SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (American Urological Association 2017).
- Positive cough test when filled urinary bladder.
- Women chose non-invasive management rather than surgical management. • • Among the 20 patients enrolled, the average age was 30-60 years old.
- Urodynamic study proven the diagnosis.
Who cannot join
- Patient of previous operation or radiation
- Uncontrolled diabetes Neuromuscular disorder
- Uncontrolled psychiatric diseases
- Pregnancy
- Lactation
- Virgin
Show all 11Show fewer
- Sepsis
- Active carcinoma
- Cystocele.
- Antiplatelet drug intake less than 7 days before and after procedure. - bleeding disorder.
- Patients cannot deal with Questionnaires.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence
Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI .
This study add the effect both HIFU and PRP together in treating SUI.
Read the detailed description
What is stress urinary incontinence (SUI)? Stress urinary incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. With mild SUI, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. If your SUI is more severe, you may also leak with less forceful activities like standing up, walking or bending over. Urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes SUI is a very common bladder problem for women. Key SUI statics About half of women age 65 and above find that they sometimes leak urine. How can SUI Affect life? Many people find that SUI gets in the way of daily and social activities. It can affect family and sexual relationships. Some people even begin to feel isolated and hopeless because of it The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this.
PRP is extremely rich in growth factors and cytokines which regulate tissue reconstruction, PRP is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject PRP under urethra to restore bulbourethral ligment .
HIFU is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .
- Conditions
- Urinary Incontinence
- Being tested
- PRP injection, Hifu procedure and PRP injection
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionDevice
Active comparator: PRP 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals. Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under the urethra. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).
Hifu procedure and PRP injectionDevice
Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.And intravaginal Hifu in4 weeks intervals. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS).
| Study group | Role | What they receive |
|---|---|---|
| Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval. | Active comparator | Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra. Receives: Device: PRP injection |
| Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU. | Active comparator | Procedure: 3 cycles of vaginal HIFU together with 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals Receives: Device: Hifu procedure and PRP injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
After one month of first session, the rate of Improvement of the stress urinary incontinence increased .
Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.
Measured: One month after first session
Secondary outcomes (1)
one month after complete three sessions ,the rate of Improvement of the urinary incontinence increased.
Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.
Measured: One month after complete three sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Mar 2022
- Primary completion1 Sep 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Ahmed Srour, Ain Shams Maternity Hospital
- Investigators
- Dina Srour, MS, Study director, Ain Shams Maternity Hospital Egypt Ain Shams University Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691334
- Sponsor's protocol ID
- Urinary incontinence
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Rich Plasma (PRP) and High Intensity Focused Ultrasound (HIFU) in Management of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06691334
- Acronym / sponsor ID
- Urinary incontinence
- Conditions
- Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 15 Nov 2024 (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.
Previous studies Results show (PRP) is safe and effective in treating SUI, other studies show the result of energy base devices (Co2 laser, HIFU) are effective in treating of SUI .
This study add the effect both HIFU and PRP together in treating SUI.
Detailed description
What is stress urinary incontinence (SUI)? Stress urinary incontinence (SUI) is when urine leaks out with sudden pressure on the bladder and urethra, causing the sphincter muscles to open briefly. With mild SUI, pressure may be from sudden forceful activities, like exercise, sneezing, laughing or coughing. If your SUI is more severe, you may also leak with less forceful activities like standing up, walking or bending over. Urinary "accidents" like this can range from a few drops of urine to enough to soak through the clothes SUI is a very common bladder problem for women. Key SUI statics About half of women age 65 and above find that they sometimes leak urine. How can SUI Affect life? Many people find that SUI gets in the way of daily and social activities. It can affect family and sexual relationships. Some people even begin to feel isolated and hopeless because of it The pelvic floor supports the bladder and urethra. If this area gets stretched, weakened or damaged, then SUI can happen. Pregnancy and childbirth can cause this.
PRP is extremely rich in growth factors and cytokines which regulate tissue reconstruction, PRP is an easily procedure and relatively inexpensive biological material, it is produce directly from patient blood and inject PRP under urethra to restore bulbourethral ligment .
HIFU is an energy-based medical technology with many clinical applications, a device is a non-invasive procedure that provides collagen remodeling and synthesis that may repair and restore pelvic floor and pubourethral ligment, it is non-invasive therapeutic technique, that uses non-ionized ultrasonic waves that provides collagen that tight the endopelvic fascia and adjacent tissues .
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval. | Active comparator | Device: PRP injectionProcedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra. |
| Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU. | Active comparator | Device: Hifu procedure and PRP injectionProcedure: 3 cycles of vaginal HIFU together with 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women complain of SUI is the symptom of urinary leakage due to increased abdominal pressure, which can be caused by activities such as sneezing, coughing, exercise, lifting, and position change (American Urological Association 2017).
- Positive cough test when filled urinary bladder.
- Women chose non-invasive management rather than surgical management. • • Among the 20 patients enrolled, the average age was 30-60 years old.
- Urodynamic study proven the diagnosis.
Key exclusion criteria (11 listed)
- Patient of previous operation or radiation
- Uncontrolled diabetes Neuromuscular disorder
- Uncontrolled psychiatric diseases
- 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 |
|---|---|---|
| PRP injectionActive comparator: PRP 3 cycles of platelet-rich plasma injection treatment in 4 weeks intervals. Procedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under the urethra. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS). | Device | Group A: 10 cases will be group which is PRP injection 2 ml below urethra in one month interval. |
| Hifu procedure and PRP injectionProcedure: PRP injection of 2ml platelet-rich plasma from centrifuged for 5 min patient's blood under urethra.And intravaginal Hifu in4 weeks intervals. Cycle patient will examined and asked to fill daily micturition plan International consolation on incontinence questionnaire-urinary incontinence short form (ICIQ UI SF), urogenital distress inventory (UDI-6), incontinence impact questionnaire (11Q-7) and over active bladder symptoms scores (OABSS). | Device | Group B: 10 cases will be group B which is PRP combined together with vaginal HIFU. |
Primary outcome
After one month of first session, the rate of Improvement of the stress urinary incontinence increased .
Time frame: One month after first session
Self-reported questionnaires were used to measure pre-Treatment symptom severity and post treatment symptom and severity.
1 secondary outcome
one month after complete three sessions ,the rate of Improvement of the urinary incontinence increased.
Time frame: One month after complete three sessions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
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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.
Dina Srour, MS study director
Ain Shams Maternity Hospital Egypt Ain Shams University Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP injection and Hifu procedure and PRP injection in people with Urinary Incontinence, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 11 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: finished, as of the sponsor's last update on 18 Nov 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
After one month of first session, the rate of Improvement of the stress urinary incontinence increased . (time frame: One month after first session). 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 18 Nov 2024.