Platelet-rich plasma versus Botox for overactive bladder that hasn't responded to medication
Intra-vesical Injection of Platelet-Rich Plasma Compared With Botox for Management of Patients With Refractory Overactive Bladder: A Comparative Randomized Study
This research tests whether platelet-rich plasma or Botox helps adults with overactive bladder who have not improved after standard medicines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Benha University Academic / other |
| Locations | 1 site (Banhā, Qalyubia Governorate) |
| Trial ID | NCT07184307 on ClinicalTrials.gov |
What this trial studies
Adults with refractory overactive bladder who have failed at least six months of standard medical therapy are randomized to receive intravesical platelet-rich plasma made from their own blood or intravesical botulinum toxin injections. Participants complete bladder diaries, symptom questionnaires, and urodynamic testing before and after treatment to measure changes in symptoms and bladder function. Botulinum toxin is an established option for refractory overactive bladder, while platelet-rich plasma is intended to deliver growth factors that may help repair the bladder lining. The trial compares symptom reduction, objective urodynamic outcomes, and safety between the two treatments.
Who should consider this trial
Good fit: Adults aged 18 or older with at least six months of urgency/frequency/nocturia (with or without urge incontinence) who have failed standard medical therapy and can complete bladder diaries, questionnaires, and urodynamic testing are ideal candidates.
Not a fit: People with active urinary tract infection, bladder outlet obstruction, prior intravesical biological therapy or pelvic/bladder surgery affecting function, bladder malignancy, indwelling catheters, pregnancy or lactation, or severe uncontrolled medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, platelet-rich plasma could offer an alternative treatment that helps repair bladder tissue and reduce urgency and leakage for people who don't respond to medicines.
How similar studies have performed: Botulinum toxin is well-established and effective for refractory overactive bladder, whereas intravesical platelet-rich plasma is a newer approach with only limited pilot data suggesting possible benefit.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Banhā, Qalyubia Governorate
- Benha University Hospital, Faculty of Medicine, Department of Urology — Banhā, Qalyubia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Tamer A Diab, MD
- Email: Tamer.diab@fmed.bu.edu.eg
- Phone: 01003583264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.