Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial

Официальное название

Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study

Обзор

Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with lifestyle changes and medicines. However, some patients do not respond to these standard treatments and continue to suffer from bothersome symptoms. This study is designed to help patients who have not improved with available medical therapy. Two treatments will be compared in this research. The first treatment uses platelet-rich plasma. Platelet-rich plasma is made from a patient's own blood and contains growth factors that may help repair the lining of the bladder and improve bladder function. The second treatment uses botulinum toxin. Botulinum toxin is a protein that can reduce unwanted bladder contractions and is already approved for use in patients with overactive bladder who did not respond to other treatments. The purpose of this study is to evaluate whether platelet-rich plasma injection into the bladder wall is safe, effective, and durable when compared with botulinum toxin injection into the bladder muscle. We believe that platelet-rich plasma may improve bladder health by encouraging tissue repair and reducing inflammation, while botulinum toxin may reduce bladder overactivity by blocking chemical signals that cause muscle contractions. This study will take place at Benha University Hospital in Egypt. About 48 adult participants with overactive bladder that has not improved after at least six months of medical therapy will be enrolled. Participants will be randomly assigned to one of two groups. One group will receive platelet-rich plasma injections into the bladder lining, and the other group will receive botulinum toxin injections into the bladder muscle. The procedures will be performed under anesthesia using a cystoscope, which is a thin instrument inserted into the bladder. Participants will be followed for one year. At several time points during follow-up, they will complete bladder symptom questionnaires, keep a voiding diary, and undergo urodynamic studies to measure bladder capacity and function. Researchers will also monitor safety by recording any side effects, such as urinary tract infections or temporary difficulty emptying the bladder. The main goal of this study is to determine whether platelet-rich plasma can reduce symptoms of overactive bladder as effectively as botulinum toxin, with fewer side effects and longer-lasting results. If successful, platelet-rich plasma could offer a new treatment option for patients who continue to struggle with overactive bladder despite standard medical therapy.

Вмешательства

• Биопрепарат Platelet-Rich Plasma
  Autologous platelet-rich plasma prepared from approximately 50 milliliters of venous blood using a two-step centrifugation protocol. Ten milliliters of platelet-rich plasma are obtained and injected into the sub-urothelial layer of the bladder wall during cystoscopy under anesthesia.
• Препарат Intravesical Botulinum Toxin Injection
  Botulinum toxin (100 units) reconstituted in 10 milliliters of saline and injected into the bladder detrusor muscle at multiple sites under cystoscopic guidance, sparing the trigone.

Первичные конечные точки

• Change in Overactive Bladder Symptom Score (OABSS) from baseline [Срок оценки: Baseline and 6 months after intervention]
• Change in Maximum Cystometric Capacity (MCC) from baseline [Срок оценки: Baseline and 6 months after intervention]

Вторичные конечные точки (4)

• Change in International Consultation on Incontinence Questionnaire-Overactive Bladder (ICIQ-OAB) score from baseline [Срок оценки: Baseline, 3 months, 6 months, 9 months, and 12 months after intervention]
• Incidence of urinary tract infection after intervention [Срок оценки: Up to 12 months after intervention]
• Incidence of urinary retention requiring catheterization [Срок оценки: Up to 12 months after intervention]
• Incidence of hematuria following intervention [Срок оценки: Within 7 days of intervention]

Критерии участия

Критерии включения

• Age 18 years or older
• History of urgency, frequency, nocturia, with or without urge urinary incontinence, lasting for at least 6 months
• Failure of standard medical treatment (antimuscarinics, beta-3 adrenergic agonists, or other appropriate therapy) for at least 6 months
• Willing and able to complete bladder diaries, questionnaires, and urodynamic testing
• Provides informed consent

Критерии исключения

• Pregnancy or lactation
• Previous intravesical biological therapy (e.g., platelet-rich plasma or botulinum toxin)
• Prior pelvic or bladder surgery that may affect bladder function
• Active urinary tract infection or sexually transmitted infection
• Vaginitis or chronic bacterial prostatitis
• Bladder or lower ureteral stones confirmed by imaging
• Bladder outlet obstruction on urodynamic study
• Bladder malignancy (mass on imaging or malignant cells on cytology)
• Use of indwelling urinary catheter
• Severe uncontrolled medical conditions (e.g., uncontrolled diabetes, advanced renal or hepatic impairment)
• Known hypersensitivity to botulinum toxin or contraindication to platelet-rich plasma preparation (e.g., coagulopathy, inability to discontinue anticoagulation safely)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Benha University Hospital, Faculty of Medicine, Department of Urology — Banhā

Идентификаторы

NCT: NCT07184307 · MD: 8-19-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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