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

RecruitingNAAges 18 Years - anyAllBenha University
NCT07184307 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
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What it tests

  • Platelet-Rich Plasma
  • Intravesical Botulinum Toxin Injection
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Where

1 site
Benha University Hospital, Faculty of Medicine, Department of Urology
Banhā, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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