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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07693192
Enrollment
60
Registered
2026-07-09
Start date
2026-06-01
Completion date
2026-12-30
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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

PROCEDUREIntravesical 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.

PROCEDUREIntravesical 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.

Sponsors

Mahmoud Mohamed Farag Ali
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Reduction in Urgency Urinary Incontinence EpisodesBaseline, 3, 6, 12, and 24 monthsChange 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026