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

NCT07693192 | Active Not Recruiting

• 1 other identifier: Rc.1.6.2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Reduction in Urgency Urinary Incontinence Episodes

  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.

  Baseline, 3, 6, 12, and 24 months

Study Arms (2)

Intravesical Botulinum Toxin A

EXPERIMENTAL

Participants in this arm will receive intravesical Botulinum Toxin A injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes.

Procedure: Intravesical Botulinum Toxin A (100U)

Intravesical Platelet-Rich Plasma (PRP)

EXPERIMENTAL

Participants in this arm will receive intravesical Platelet-Rich Plasma (PRP) injection according to the study protocol and will be followed for 2 years to assess efficacy and safety outcomes.

Procedure: Intravesical Platelet-Rich Plasma

Interventions

Intravesical Botulinum Toxin A (100U) PROCEDURE

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.

Also known as: Botox

Intravesical Botulinum Toxin A

Intravesical Platelet-Rich Plasma PROCEDURE

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.

Also known as: PRP

Intravesical Platelet-Rich Plasma (PRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years
• Diagnosis of refractory overactive bladder (OAB)
• Failed at least 2 pharmacological therapies
• Willing and able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahmoud Mohamed Farag Ali: lead

Study Sites (1)

Benha University Hospital

Banhā, Al Qalyubia, 13511, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-06

Locations

EG (1)