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.
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.
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.
Single group
Autologous Platelet-Rich Plasma
Biological/VaccineAutologous 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.
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.
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.
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.
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.
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