Peri-Urethral Platelet-Rich Plasma Injections for Postmenopausal Female Stress Urinary Incontinence
1 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
70
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Mina R Banoub, MBBCh
- Numero di telefono: +2 0 12 89930607
- Email: Minaraafatbanoob@gmail.com
Luoghi di studio
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Qalyubia Governorate
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Banhā, Qalyubia Governorate, Egitto, 13511
- Benha University Hospital
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Treatment Success Based on Global Response Assessment Score
Lasso di tempo: 1 month after the fourth platelet-rich plasma injection
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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.
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1 month after the fourth platelet-rich plasma injection
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Dry Rate
Lasso di tempo: 1, 3, and 6 months after the fourth platelet-rich plasma injection
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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.
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1, 3, and 6 months after the fourth platelet-rich plasma injection
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Change in Stress Urinary Incontinence Severity Assessed by the Visual Analogue Scale
Lasso di tempo: Baseline through 6 months after the fourth platelet-rich plasma injection
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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.
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Baseline through 6 months after the fourth platelet-rich plasma injection
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Change in Abdominal Leak Point Pressure
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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.
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Baseline and 3 months after the fourth platelet-rich plasma injection
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Change in Maximum Urinary Flow Rate
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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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Baseline and 3 months after the fourth platelet-rich plasma injection
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Change in Voided Urine Volume
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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.
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Baseline and 3 months after the fourth platelet-rich plasma injection
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Change in Post-Void Residual Urine Volume
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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.
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Baseline and 3 months after the fourth platelet-rich plasma injection
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Change in Cystometric Bladder Capacity
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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.
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Baseline and 3 months after the fourth platelet-rich plasma injection
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Change in Voiding Detrusor Pressure at Maximum Urinary Flow Rate
Lasso di tempo: Baseline and 3 months after the fourth platelet-rich plasma injection
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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.
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Baseline and 3 months after the fourth platelet-rich plasma injection
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Incidence of Treatment-Related Adverse Events
Lasso di tempo: Through 6 months after the fourth platelet-rich plasma injection
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Treatment safety will be assessed by recording the occurrence of adverse events.
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Through 6 months after the fourth platelet-rich plasma injection
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 settembre 2026
Completamento primario (Stimato)
15 marzo 2027
Completamento dello studio (Stimato)
30 marzo 2027
Date di iscrizione allo studio
Primo inviato
1 settembre 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 settembre 2026
Primo Inserito (Effettivo)
8 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali maschili
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Disturbi della minzione
- Sintomi del tratto urinario inferiore
- Manifestazioni urologiche
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Incontinenza urinaria
- Incontinenza urinaria, Stress
Altri numeri di identificazione dello studio
- MS.25.7.2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .