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NCT Number: NCT07807982

Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal 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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Platelet-Rich Plasma

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Dry Rate

    Time frame: 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.

  2. 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

    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.

  3. Change in Abdominal Leak Point Pressure

    Time frame: 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.

  4. Change in Maximum Urinary Flow Rate

    Time frame: 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.

  5. Change in Voided Urine Volume

    Time frame: 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.

  6. Change in Post-Void Residual Urine Volume

    Time frame: 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.

  7. Change in Cystometric Bladder Capacity

    Time frame: 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.

  8. Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate

    Time frame: 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.

  9. Incidence of Treatment-Related Adverse Events

    Time frame: Through 6 months after the fourth platelet-rich plasma injection

    Treatment safety will be assessed by recording the occurrence of adverse events.

Study contacts

Contact information is provided by the study sponsor or research team.

Mina R Banoub, MBBCh

CONTACT

[email protected]

0 12 89930607 ext. +2

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Peri-Urethral Injections of Platelet-Rich Plasma in Treatment of Post-Menopausal Female Stress Urinary Incontinence

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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