Mixed Urinary IncontinencePRPNCT06769074
Assessment of Platelet Rich Plasma Injection in Managing Female Patients Complaining of Mixed Urinary Incontinence (PRP)
A study testing Platelet Rich Plasma in people with Mixed Urinary Incontinence, run by Zagazig University at 2 sites in Egypt.
Trial summary
The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and… Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Mixed Urinary Incontinence
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesEgypt
- Study dates
- 28 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with MUI ( mild and moderate degree of stress incontinence)
- Age between 20 to 60 years -
Who cannot join
- intrinsic sphincteric deficiency (ISD)
- Pregnancy
- Sepsis
- Acute and chronic infections
- Chronic liver disease
- Anti-coagulation therapy
- History of malignancy
- Under anti-platelet agent treatment
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Zagazig University
Egypt
Zagazig university hospital , Egypt
Zagazig
About this study
Official title: Assessment of Role of Platelet Rich Plasma in Managing Women with Mixed Urinary Incontinence
The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and urgency incontinence treatment
Participants will:
- Undergo PRP injection in to mid urethra , and installation into bladder every 1 month for 3 month
- Visit the clinic once every 1 month for checkups and urodynamic study after 3 month, and 4 month after last installation
Read the detailed description
All patients will be subjected to:
- An informed consent will be taken from every patient.
- Complete history taking:
- Personal history
- Any complaint.
- Past medical and past surgical history.
- Family history.
- Severity of incontinence by International consultation on incontinence questionnaire- short form (ICIQ-SF), OAB symptom score ,Cough stress test *Complete physical examination.
- General examination: Vital signs (Blood pressure, Temperature, Heart rate, Respiratory rate).
- neurological examination: gait, perineal sensation, bulbocavernous reflex, cognitive status
- abdominal examination : distended bladder, masses , hernia, DRE
- Pelvic examination: vaginal atrophy, skin excoriation, vault examination, organ prolapse, pelvic floor muscle strength , cough test, Q tip test, Marshall test
- urodynamics done for documentation of detrusor overactivity before and after PRP installation after 3rd instillation and 4 m after last instillation
- patient is placed in the dorsal lithotomy position
- PRP is obtained from a sample of patients' blood drawn at the time of treatment
- A 30 cc venous blood draw will yield 3-5 cc of PRP
- The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A( .5 ml)to prevent platelet activation prior to its use
- in room temp 21-24 to avoid activation of platelet
- a specialized 'table top cold centrifuge' device to centrifugate the sample
- After centrifugation, each vial was confirmed to contain three layers from top to bottom, namely, the platelet pellet, gel, and red blood cells. The platelet pellet was remixed with the supernatant by inverting the tubes gently 5-10 times.
- A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
- 10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
- patient received four injections of PRP at monthly intervals
- follow up done after 3rd instillation and 4 months after finishing injections
- follow up done by subjective symptoms as previous scoring system and objective by Urodynamics
- Conditions
- Mixed Urinary Incontinence
- Being tested
- Platelet Rich Plasma
- Keywords
- Mixed urinary incontinence, Platelet rich plasma, stress urinary incontinence
- 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.
Platelet Rich PlasmaBiological
PRP injection into the midurethra and its instillation into urinary bladder
| Study group | Role | What they receive |
|---|---|---|
| PRP injection at midurethra with PRP instillation into urinary bladder | Experimental | A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
*10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter Receives: Biological: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.
Treatment -related improvement of urinary incontinence is assessed using:
- International consultation on incontinence questionnaire- short form (ICIQ-SF).
- OAB symptom score.
- Cough stress test.
- Urodynamics.
- ICIQ-Sf questionnaire before and after treatment: Scoring scale: 0-21, minimum 0, maximum 21. A higher score indicates greater impairment from incontinence.
- OAB symptom score: has a maximum score of 15 with more weight assigned to urgency and urgency incontinence than on frequency. Higher score indicates greater impairment from incontinence.
- Urodynamics: for assessment of of detrusor over-activity before and after treatment.
Measured: From enrollment to the end of intervention at 6 month "
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start28 Dec 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769074
- Sponsor's protocol ID
- 782/29-oct-2024
- Acronym
- PRP
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Role of Platelet Rich Plasma in Managing Women with Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06769074
- Acronym / sponsor ID
- PRP / 782/29-oct-2024
- Conditions
- Mixed Urinary Incontinence
- Keywords
- Mixed urinary incontinence, Platelet rich plasma, stress urinary incontinence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Jan 2025 (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.
The goal of this clinical trial is to assess the efficacy of platelet-rich plasma (PRP) for the treatment of mixed urinary incontinence determine .The main question it aims to answer whether PRP is it safe and effective in managing mixed urinary incontinence? Researchers will assess efficacy of PRP in both stress and urgency incontinence treatment
Participants will:
- Undergo PRP injection in to mid urethra , and installation into bladder every 1 month for 3 month
- Visit the clinic once every 1 month for checkups and urodynamic study after 3 month, and 4 month after last installation
Detailed description
All patients will be subjected to:
- An informed consent will be taken from every patient.
- Complete history taking:
- Personal history
- Any complaint.
- Past medical and past surgical history.
- Family history.
- Severity of incontinence by International consultation on incontinence questionnaire- short form (ICIQ-SF), OAB symptom score ,Cough stress test *Complete physical examination.
- General examination: Vital signs (Blood pressure, Temperature, Heart rate, Respiratory rate).
- neurological examination: gait, perineal sensation, bulbocavernous reflex, cognitive status
- abdominal examination : distended bladder, masses , hernia, DRE
- Pelvic examination: vaginal atrophy, skin excoriation, vault examination, organ prolapse, pelvic floor muscle strength , cough test, Q tip test, Marshall test
- urodynamics done for documentation of detrusor overactivity before and after PRP installation after 3rd instillation and 4 m after last instillation
- patient is placed in the dorsal lithotomy position
- PRP is obtained from a sample of patients' blood drawn at the time of treatment
- A 30 cc venous blood draw will yield 3-5 cc of PRP
- The blood draw occurs with the addition of an anticoagulant, such as citrate dextrose A( .5 ml)to prevent platelet activation prior to its use
- in room temp 21-24 to avoid activation of platelet
- a specialized 'table top cold centrifuge' device to centrifugate the sample
- After centrifugation, each vial was confirmed to contain three layers from top to bottom, namely, the platelet pellet, gel, and red blood cells. The platelet pellet was remixed with the supernatant by inverting the tubes gently 5-10 times.
- A-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra
- 10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter
- patient received four injections of PRP at monthly intervals
- follow up done after 3rd instillation and 4 months after finishing injections
- follow up done by subjective symptoms as previous scoring system and objective by Urodynamics
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRP injection at midurethra with PRP instillation into urinary bladder | Experimental | Biological: Platelet Rich PlasmaA-PRP was injected into the anterior vaginal mucosa around the mid-urethral area, which was approximately 1 cm below the urethral meatus and had a depth of about 1.5 cm; 2 mL were injected underneath the mid-urethral area and 1.5 mL was injected on either side of the urethra *10ml PRP used to instill intravesical for urgency urinary incontinence by urethral catheter |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women with MUI ( mild and moderate degree of stress incontinence)
- Age between 20 to 60 years -
Key exclusion criteria (8 listed)
- intrinsic sphincteric deficiency (ISD)
- Pregnancy
- Sepsis
- Acute and chronic infections
- Chronic liver disease
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 PlasmaPRP injection into the midurethra and its instillation into urinary bladder | Biological | PRP injection at midurethra with PRP instillation into urinary bladder |
Primary outcome
Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation.
Time frame: From enrollment to the end of intervention at 6 month "
Treatment -related improvement of urinary incontinence is assessed using: * International consultation on incontinence questionnaire- short form (ICIQ-SF). * OAB symptom score. * Cough stress test. * Urodynamics. 1. ICIQ-Sf questionnaire before and after treatment: Scoring scale: 0-21, minimum 0, maximum 21. A higher score indicates greater impairment from incontinence. 2. OAB symptom score: has a maximum score of 15 with more weight assigned to urgency and urgency incontinence than on frequency. Higher score indicates greater impairment from incontinence. 3. Urodynamics: for assessment of of detrusor over-activity before and after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
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Pelvic Floor Rehabilitation Programme for Women With Urinary Incontinence in a Peruvian Public Hospital
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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.
2 sites 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 Mixed Urinary Incontinence, run by Zagazig University at 2 sites 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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of females with treatment-related improvement of mixed urinary incontinence after receiving platelet-rich plasma (PRP) injection and instillation. (time frame: From enrollment to the end of intervention at 6 month "). 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 Jan 2025.