Status:

RECRUITING

Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial

Lead Sponsor:

Benha University

Conditions:

Overactive Bladder Syndrome

Urinary Urge Incontinence

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Overactive bladder is a common condition that causes sudden urges to urinate, frequent urination, night-time urination, and sometimes leakage of urine. Many people with overactive bladder improve with...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

April 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 15 2026

Estimated Enrollment :

48 Patients enrolled

Trial Details

Trial ID

NCT07184307

Start Date

April 15 2025

End Date

April 15 2026

Last Update

September 19 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

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Benha University Hospital, Faculty of Medicine, Department of Urology

Banhā, Qalyubia Governorate, Egypt, 13511

Platelet-Rich Plasma Versus Botulinum Toxin for Refractory Overactive Bladder: A Randomized Trial | DecenTrialz