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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Overactive Bladder Symptom Score (OABSS) from baseline — Baseline and 6 months after intervention
  The Overactive Bladder Symptom Score (OABSS) is a patient-reported questionnaire with 4 items: daytime frequency (0-2), night-time frequency (0-3), urgency (0-5), and urge urinary incontinence (0-5). The total score ranges from 0 to 15, with higher scores indicating more severe symptoms. The outcome measure is the change in total OABSS score from baseline to follow-up.
• Change in Maximum Cystometric Capacity (MCC) from baseline — Baseline and 6 months after intervention
  Maximum cystometric capacity (MCC) is measured during urodynamic testing as the bladder volume at which the patient can no longer delay urination, experiences strong desire to void, or involuntary detrusor contractions occur. Higher values indicate improved bladder storage capacity. The outcome measure is the change in MCC (in milliliters) from baseline to follow-up.

Trial sites (1)

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