An interventional study of Autologous Platelet-Rich Plasma in Stress Urinary Incontinence, sponsored by Benha University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Benha University · Not applicable, Interventional, and Treatment
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.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's planned enrollment of 70 is close to the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Autologous Platelet-Rich Plasma
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.
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.
Time frame: 1 month after the fourth platelet-rich plasma injection
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through 6 months after the fourth platelet-rich plasma injection
Plan to share: No
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Studies of the drug tested here: Platelet rich plasma
Urinary Incontinence, Stress →