Stress Urinary Incontinence
Conditions
Keywords
Postmenopausal Women, Platelet-Rich Plasma, Peri-Urethral Injection, Intrinsic Sphincter Deficiency, Urethral Sphincter, Urinary Incontinence, Urodynamic Evaluation, Regenerative Therapy
Brief 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. 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.
Interventions
BIOLOGICALAutologous 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.
Sponsors
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success Based on Global Response Assessment Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dry Rate | 1, 3, and 6 months after the fourth platelet-rich plasma injection | 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 | Baseline through 6 months after the fourth platelet-rich plasma injection | 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 | Baseline and 3 months after the fourth platelet-rich plasma injection | 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 | Baseline and 3 months after the fourth platelet-rich plasma injection | 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. |
| Change in Voided Urine Volume | Baseline and 3 months after the fourth platelet-rich plasma injection | 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. |
| Change in Post-Void Residual Urine Volume | Baseline and 3 months after the fourth platelet-rich plasma injection | 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. |
| Change in Cystometric Bladder Capacity | Baseline and 3 months after the fourth platelet-rich plasma injection | 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. |
| Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate | Baseline and 3 months after the fourth platelet-rich plasma injection | 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. |
| Incidence of Treatment-Related Adverse Events | Through 6 months after the fourth platelet-rich plasma injection | Treatment safety will be assessed by recording the occurrence of adverse events. |
Countries
Egypt
Contacts
CONTACTMina R Banoub, MBBCh
Outcome results
None listed