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Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence

1 september 2026 uppdaterad av: Mina Raafat Attia Banoub, Benha University

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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Egypten
    • Qalyubia Governorate
      • Banhā, Qalyubia Governorate, Egypten, 13511
        • Benha University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Peri-Urethral Platelet-Rich Plasma Injection
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.
Biologisk: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Treatment Success Based on Global Response Assessment Score
Tidsram: 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.
1 month after the fourth platelet-rich plasma injection

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Dry Rate
Tidsram: 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.
1, 3, and 6 months after the fourth platelet-rich plasma injection
Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale
Tidsram: 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.
Baseline through 6 months after the fourth platelet-rich plasma injection
Change in Abdominal Leak Point Pressure
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Maximum Urinary Flow Rate
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voided Urine Volume
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Post-Void Residual Urine Volume
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Cystometric Bladder Capacity
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate
Tidsram: 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.
Baseline and 3 months after the fourth platelet-rich plasma injection
Incidence of Treatment-Related Adverse Events
Tidsram: Through 6 months after the fourth platelet-rich plasma injection
Treatment safety will be assessed by recording the occurrence of adverse events.
Through 6 months after the fourth platelet-rich plasma injection

Samarbetspartners och utredare

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Sponsor

Benha University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 september 2026

Primärt slutförande (Beräknad)

15 mars 2027

Avslutad studie (Beräknad)

30 mars 2027

Studieregistreringsdatum

Först inskickad

1 september 2026

Först inskickad som uppfyllde QC-kriterierna

1 september 2026

Första postat (Faktisk)

8 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MS.25.7.2026

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NEJ

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