Stress Urinary IncontinenceNCT05295420
The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
A study testing platelet rich plasma in people with Stress Urinary Incontinence and Urinary Incontinence, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). Read more about this study
- Who is it for?
- Ages 35 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Urinary Incontinence
- What is being tested?
- platelet rich plasma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 30 Jun 2022
- 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 35 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patient with mild to moderate SUI
Who cannot join
- Under anti-platelet agent treatment
- Platelet dysfunction syndrome
- Critical thrombocytopenia
- Acute and chronic infections
- Anti-coagulation therapy
- History of malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.
Read the detailed description
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation.
Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.
The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion.
Hence, there is a need for alternative efficacious, outpatient SUI treatments. Platelet-derived therapies are a growing trend across multiple medical and surgical specialties. Evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines.
These biologically active proteins include transforming growth factor-β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin-like growth factor, vascular endothelial growth factor. These growth factors are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation. The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing.
One of the most well-described platelet-based therapies is autologous platelet-rich plasma (PRP). PRP is derived from the centrifugation of whole blood with a separator gel to remove the red and white blood cells. The resulting supernatant has a greater than four-fold increase in platelets and other plasma proteins. This concentrate is then administered via injection.
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Being tested
- platelet rich plasma
- Medical subject headings
- Urinary Incontinence, Stress, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
platelet rich plasmaProcedure or surgery
Injection of Platelet Rich Plasma in the female conditions that suffer from SUI
| Study group | Role | What they receive |
|---|---|---|
| platelet-rich plasma | Experimental | to assess the role of platelet-rich plasma in the treatment of SUI as a non-invasive method Receives: Procedure: platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary incontinence severity by PRP treatment
Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,
Measured: From baseline to 3 months after the PRP treatment day.
Secondary outcomes (1)
Patients can control voiding on stress
Assessment of the patient urine control status as daily pad use, maximum flow rate, and urine residual.
Measured: From baseline to first month and continued to 3 months after the treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Mar 2022
- Primary completion15 Jun 2022
- Study completion30 Jun 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295420
- Sponsor's protocol ID
- Ahmed Tahoon
- Status last verified
- Jul 2023
- First submitted
- 27 Feb 2022
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Platelet Rich Plasma Injections in Cases of Stress Incontinence
- ClinicalTrials.gov ID
- NCT05295420
- Acronym / sponsor ID
- Ahmed Tahoon
- Conditions
- Stress Urinary Incontinence, Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Collaborators
- Al-Azhar University
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Mar 2022 (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.
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.
Detailed description
Urinary incontinence can impact on one's social, physical, mental, and sexual wellbeing, and lead to depression and social isolation.
Stress urinary incontinence (SUI) refers to the involuntary leakage of urine accompanying physical exertion (i.e. coughing, exercise, and sneezing). It is commonly acquired after pregnancy and childbirth due to the weakening of the pelvic floor muscles that support the urethra against the anterior vaginal wall.
Current SUI treatment includes surgery to re-establish sufficient urethral resistance in order to prevent urine leakage during increased intra-abdominal pressure.
The mid-urethral sling (MUS) has become the preferred procedure, as it is less invasive than the Burch colposuspension. However, the MUS procedure has a 5-20% failure rate and carries risks such as infection, voiding dysfunction, hemorrhage, pain, bladder or urethral injury, and mesh erosion.
Hence, there is a need for alternative efficacious, outpatient SUI treatments. Platelet-derived therapies are a growing trend across multiple medical and surgical specialties. Evidence suggests that platelets play an important role in tissue repair, vascular remodeling and inflammatory and immune responses through secretion of growth factors, cytokines, and chemokines.
These biologically active proteins include transforming growth factor-β, platelet-derived growth factor, platelet-derived epithelial growth factor, insulin-like growth factor, vascular endothelial growth factor. These growth factors are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation. The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing.
One of the most well-described platelet-based therapies is autologous platelet-rich plasma (PRP). PRP is derived from the centrifugation of whole blood with a separator gel to remove the red and white blood cells. The resulting supernatant has a greater than four-fold increase in platelets and other plasma proteins. This concentrate is then administered via injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platelet-rich plasma | Experimental | Procedure: platelet rich plasmato assess the role of platelet-rich plasma in the treatment of SUI as a non-invasive method |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female patient with mild to moderate SUI
Key exclusion criteria (6 listed)
- Under anti-platelet agent treatment
- Platelet dysfunction syndrome
- Critical thrombocytopenia
- Acute and chronic infections
- Anti-coagulation therapy
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 |
|---|---|---|
| platelet rich plasmaInjection of Platelet Rich Plasma in the female conditions that suffer from SUI | Procedure or surgery | platelet-rich plasma |
Primary outcome
urinary incontinence severity by PRP treatment
Time frame: From baseline to 3 months after the PRP treatment day.
Assessment of urinary incontinence severity by visual analog scale as: from 0 -10,
1 secondary outcome
Patients can control voiding on stress
Time frame: From baseline to first month and continued to 3 months after the treatment day
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 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing platelet rich plasma in people with Stress Urinary Incontinence and Urinary Incontinence, run by Egymedicalpedia 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 1 inclusion and 6 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 10 Jul 2023. 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?
urinary incontinence severity by PRP treatment (time frame: From baseline to 3 months after the PRP treatment day.). 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 10 Jul 2023.