Stress Urinary IncontinenceNCT07807982
Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence
A study testing Autologous Platelet-Rich Plasma in people with Stress Urinary Incontinence, run by Benha University at 1 site in Egypt.
Trial summary
his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Autologous Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2026to 30 Mar 2027
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 45 years or older.
- Stress urinary incontinence confirmed by urodynamic study with intrinsic sphincter deficiency.
- Persistent stress urinary incontinence requiring pad use despite conservative management.
- Patients unfit for surgical intervention and anesthesia.
- Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued.
- Patients with comorbidities.
Who cannot join
- Urinary tract infection.
- Neurological disorders affecting lower urinary tract function.
- Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification system.
- Previous urethral surgery.
- Inability or unwillingness to comply with follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Peri-Urethral Injections of Platelet-Rich Plasma in Treatment of Post-Menopausal Female Stress Urinary Incontinence
his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration.
Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events.
The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Autologous Platelet-Rich Plasma
- Keywords
- Postmenopausal Women, Platelet-Rich Plasma, Peri-Urethral Injection, Intrinsic Sphincter Deficiency, Urethral Sphincter, Urinary Incontinence, Urodynamic Evaluation, Regenerative Therapy
- 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.
Autologous Platelet-Rich PlasmaBiological
Autologous platelet-rich plasma will be prepared from 30 to 50 milliliters of peripheral blood using a two-step centrifugation technique. The first centrifugation will be performed at 200 × g for 20 minutes at 20 degrees Celsius, followed by a second centrifugation at 2000 × g for 20 minutes at 20 degrees Celsius. The final 5 milliliters of platelet-rich plasma, with an expected platelet concentration approximately 2.5 to 5 times the baseline platelet concentration, will be used for peri-urethral injection.
| Study group | Role | What they receive |
|---|---|---|
| Peri-Urethral Platelet-Rich Plasma Injection | Experimental | Participants will receive autologous platelet-rich plasma injections under local anesthesia. A total of 5 milliliters of platelet-rich plasma will be administered, with 1 milliliter injected at each of five peri-urethral submucosal sites corresponding to the 12, 2, 5, 7, and 10 o'clock positions. The injection procedure will be repeated once monthly for four consecutive months. Routine urinary catheterization will not be required after the procedure. Receives: Biological: Autologous Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success Based on Global Response Assessment Score
Treatment response will be assessed using the Global Response Assessment score, which ranges from -3 to +3. A score of -3 indicates markedly worse symptoms, -2 indicates moderately worse symptoms, -1 indicates mildly worse symptoms, 0 indicates no change, +1 indicates mild improvement, +2 indicates moderate improvement, and +3 indicates marked improvement. Treatment success will be defined as a Global Response Assessment score of +2 or +3. The result will be reported as the number and percentage of participants achieving treatment success.
Measured: 1 month after the fourth platelet-rich plasma injection
Secondary outcomes (9)
Dry Rate
Dry rate will be defined as the proportion of participants achieving complete continence without urinary leakage and without the need for pad protection. The number and percentage of participants who are completely dry will be recorded.
Measured: 1, 3, and 6 months after the fourth platelet-rich plasma injection
Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale
Stress urinary incontinence severity will be assessed using a 10-point Visual Analogue Scale modified from the Stamey grading system, ranging from 0 to 10, with higher scores indicating more severe urinary incontinence.
Measured: Baseline through 6 months after the fourth platelet-rich plasma injection
Change in Abdominal Leak Point Pressure
Abdominal leak point pressure will be measured during urodynamic evaluation at full bladder. The change in abdominal leak point pressure from baseline will be assessed, with the measurement reported in centimeters of water.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Maximum Urinary Flow Rate
Maximum urinary flow rate will be measured during urodynamic evaluation and reported in milliliters per second. The value obtained 3 months after the fourth platelet-rich plasma injection will be compared with the baseline value.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voided Urine Volume
Voided urine volume will be measured during urodynamic evaluation and reported in milliliters. The value obtained 3 months after the fourth platelet-rich plasma injection will be compared with the baseline value.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Post-Void Residual Urine Volume
Post-void residual urine volume will be measured following voiding during urodynamic evaluation and reported in milliliters. The measurement obtained 3 months after the fourth platelet-rich plasma injection will be compared with the baseline measurement.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Cystometric Bladder Capacity
Cystometric bladder capacity will be measured during urodynamic evaluation and reported in milliliters. The measurement obtained 3 months after the fourth platelet-rich plasma injection will be compared with the baseline measurement.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate
Voiding detrusor pressure at the maximum urinary flow rate will be measured during urodynamic evaluation and reported in centimeters of water. The measurement obtained 3 months after the fourth platelet-rich plasma injection will be compared with the baseline measurement.
Measured: Baseline and 3 months after the fourth platelet-rich plasma injection
Incidence of Treatment-Related Adverse Events
Treatment safety will be assessed by recording the occurrence of adverse events.
Measured: Through 6 months after the fourth platelet-rich plasma injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion30 Mar 2027 (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.
- More trials run by Benha 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
- Model description
- All enrolled participants will receive peri-urethral injections of autologous platelet-rich plasma once monthly for four consecutive months and will be followed to evaluate treatment efficacy and safety.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Raafat Attia Banoub, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807982
- Sponsor's protocol ID
- MS.25.7.2026
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Urethral Injections of Platelet-Rich Plasma in Treatment of Post-Menopausal Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT07807982
- Acronym / sponsor ID
- MS.25.7.2026
- Conditions
- Stress Urinary Incontinence
- Keywords
- Postmenopausal Women, Platelet-Rich Plasma, Peri-Urethral Injection, Intrinsic Sphincter Deficiency, Urethral Sphincter, Urinary Incontinence, Urodynamic Evaluation, Regenerative Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 8 Sep 2026 (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.
his prospective interventional study will evaluate the effectiveness and safety of peri-urethral injections of platelet-rich plasma for treating stress urinary incontinence in postmenopausal women. Platelet-rich plasma is prepared from each participant's own blood and contains concentrated platelets and growth factors that may promote tissue repair and regeneration.
Approximately 70 postmenopausal women with stress urinary incontinence will receive peri-urethral platelet-rich plasma injections once monthly for four consecutive months. Platelet-rich plasma will be injected into five sites around the urethra. Participants will be followed after treatment to assess improvement in urinary leakage and urinary symptoms, changes in urodynamic measurements, and treatment-related adverse events.
The study aims to determine whether repeated peri-urethral platelet-rich plasma injections can provide a safe and effective minimally invasive treatment option for postmenopausal women with stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive peri-urethral injections of autologous platelet-rich plasma once monthly for four consecutive months and will be followed to evaluate treatment efficacy and safety.
| Arm | Type | Receives |
|---|---|---|
| Peri-Urethral Platelet-Rich Plasma Injection | Experimental | Biological: Autologous Platelet-Rich PlasmaParticipants will receive autologous platelet-rich plasma injections under local anesthesia. A total of 5 milliliters of platelet-rich plasma will be administered, with 1 milliliter injected at each of five peri-urethral submucosal sites corresponding to the 12, 2, 5, 7, and 10 o'clock positions. The injection procedure will be repeated once monthly for four consecutive months. Routine urinary catheterization will not be required after the procedure. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women aged 45 years or older.
- Stress urinary incontinence confirmed by urodynamic study with intrinsic sphincter deficiency.
- Persistent stress urinary incontinence requiring pad use despite conservative management.
- Patients unfit for surgical intervention and anesthesia.
- Coagulation disorders or current anticoagulant therapy that cannot be safely discontinued.
Key exclusion criteria (5 listed)
- Urinary tract infection.
- Neurological disorders affecting lower urinary tract function.
- Pelvic organ prolapse greater than stage II according to the Pelvic Organ Prolapse Quantification system.
- Previous urethral surgery.
- Inability or unwillingness to comply with follow-up visits.
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 |
|---|---|---|
| Autologous Platelet-Rich PlasmaAutologous platelet-rich plasma will be prepared from 30 to 50 milliliters of peripheral blood using a two-step centrifugation technique. The first centrifugation will be performed at 200 × g for 20 minutes at 20 degrees Celsius, followed by a second centrifugation at 2000 × g for 20 minutes at 20 degrees Celsius. The final 5 milliliters of platelet-rich plasma, with an expected platelet concentration approximately 2.5 to 5 times the baseline platelet concentration, will be used for peri-urethral injection. | Biological | Peri-Urethral Platelet-Rich Plasma Injection |
Primary outcome
Treatment Success Based on Global Response Assessment Score
Time frame: 1 month after the fourth platelet-rich plasma injection
Treatment response will be assessed using the Global Response Assessment score, which ranges from -3 to +3. A score of -3 indicates markedly worse symptoms, -2 indicates moderately worse symptoms, -1 indicates mildly worse symptoms, 0 indicates no change, +1 indicates mild improvement, +2 indicates moderate improvement, and +3 indicates marked improvement. Treatment success will be defined as a Global Response Assessment score of +2 or +3. The result will be reported as the number and percentage of participants achieving treatment success.
9 secondary outcomes
Dry Rate
Time frame: 1, 3, and 6 months after the fourth platelet-rich plasma injection
Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale
Time frame: Baseline through 6 months after the fourth platelet-rich plasma injection
Change in Abdominal Leak Point Pressure
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Maximum Urinary Flow Rate
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voided Urine Volume
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Post-Void Residual Urine Volume
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Cystometric Bladder Capacity
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate
Time frame: Baseline and 3 months after the fourth platelet-rich plasma injection
Incidence of Treatment-Related Adverse Events
Time frame: Through 6 months after the fourth platelet-rich plasma injection
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 8 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Plasma in people with Stress Urinary Incontinence, run by Benha University 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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Sep 2026. 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?
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?
Contact Mina R Banoub, MBBCh (0 12 89930607 ext. +2, Minaraafatbanoob@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success Based on Global Response Assessment Score (time frame: 1 month after the fourth platelet-rich plasma injection). 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 8 Sep 2026.