Overactive Bladder
Conditions
Brief 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.
Detailed description
The purpose of this prospective randomized clinical trial is to compare the efficacy and safety of intravesical Platelet-Rich Plasma (PRP) injection with intravesical Botulinum Toxin A injection in adult patients with refractory overactive bladder (OAB) who have failed or were intolerant to conventional medical therapy. Overactive bladder is a chronic condition characterized by urinary urgency, usually accompanied by increased daytime frequency and nocturia, with or without urgency urinary incontinence, and has a significant negative impact on patients' quality of life. Botulinum Toxin A is an established third-line treatment for refractory OAB; however, its use may be associated with adverse events such as urinary retention, increased post-void residual urine, and urinary tract infection. Platelet-Rich Plasma has recently emerged as a regenerative therapeutic option because of its anti-inflammatory and tissue-repair properties and may provide symptom improvement with fewer complications. The primary objective of this study is to compare the improvement in overactive bladder symptoms between the two treatment groups over a 2-year follow-up period. Secondary objectives include comparing quality of life, urinary frequency, urgency episodes, urgency urinary incontinence episodes, nocturia, functional bladder capacity, post-void residual urine volume, patient satisfaction, durability of treatment response, and treatment-related adverse events. Eligible participants will be randomly assigned to receive either intravesical Botulinum Toxin A injection or intravesical Platelet-Rich Plasma injection according to the study protocol. Baseline assessment will include medical history, physical examination, symptom evaluation using validated questionnaires, voiding diary, laboratory investigations, and other investigations as indicated. Participants will undergo scheduled follow-up visits throughout the 2-year study period to assess clinical response, monitor for adverse events, and evaluate the need for additional treatment.
Interventions
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.
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.
Sponsors
Study design
Intervention model description
Participants will be randomly assigned to one of two parallel treatment groups: intravesical Botulinum Toxin A or intravesical Platelet-Rich Plasma (PRP). Both groups will be followed for 2 years to compare efficacy and safety outcomes.
Eligibility
Inclusion criteria
* Adults aged ≥18 years * Diagnosis of refractory overactive bladder (OAB) * Failed at least 2 pharmacological therapies * Willing and able to provide informed consent
Exclusion criteria
* Neurogenic bladder * Active urinary tract infection (UTI) * Pregnancy or lactation * Known allergy to botulinum toxin or any PRP components * History of pelvic radiation or bladder malignancy * Uncontrolled coagulopathy or bleeding disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Urgency Urinary Incontinence Episodes | Baseline, 3, 6, 12, and 24 months | Change from baseline in mean number of urgency urinary incontinence episodes per 24 hours, assessed by 3-day voiding diary at 3, 6, 12, and 24 months post-treatment. |
Countries
Egypt