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ACTIVE NOT RECRUITING
NCT07693192
NA

Comparative Efficacy and Safety if Intravesical Botulinum Toxin A Versus Platelet-Rich Plasma in the Management of Refractory Overactive Bladder : A 2 Year Study

Sponsor: Mahmoud Mohamed Farag Ali

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare the efficacy and safety of intravesical Botulinum Toxin A versus intravesical Platelet-Rich Plasma (PRP) in adults with refractory overactive bladder who have not responded adequately to conventional medical treatment. The main questions it aims to answer are: * Whether intravesical PRP is as effective as intravesical Botulinum Toxin A in improving overactive bladder symptoms. * Whether intravesical PRP has a better safety profile and lower incidence of adverse events during the 2-year follow-up period. Researchers will compare participants receiving intravesical Botulinum Toxin A with those receiving intravesical PRP to determine differences in symptom improvement, quality of life, urodynamic outcomes, and treatment-related adverse events. Participants will: * Receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection. * Undergo baseline clinical assessment, symptom evaluation, and urodynamic studies as indicated. * Attend scheduled follow-up visits over a 2-year period. * Complete validated questionnaires assessing overactive bladder symptoms and quality of life. * Be monitored for treatment efficacy and any adverse events throughout the study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-06-01

Completion Date

2026-12-30

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

PROCEDURE

Intravesical Botulinum Toxin A (100U)

Single intravesical injection of 100 units of Botulinum Toxin A (Botox) administered via cystoscopy under local or general anesthesia. The toxin is injected into 20-30 sites across the detrusor muscle, sparing the trigone. Patients are followed for efficacy and safety outcomes over 24 months.

PROCEDURE

Intravesical Platelet-Rich Plasma

Intravesical instillation of autologous platelet-rich plasma (PRP) prepared from patient's own blood, administered weekly for 3 consecutive sessions. Each session involves PRP instillation via urethral catheter, retained for 30 minutes.

Locations (1)

Benha University Hospital

Banhā, Al Qalyubia, Egypt