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Botulinum A toxin (BoNT/A) injections in patients with painful bladder syndrome (PBS) associated with increased urinary frequency refractory to conventional treatments versus bladder over distention,which is considered a conventional treatment.
Patients with PBS will be enrolled and randomized to receive: Bot A Toxin one single injections treatment versus one single bladder over distention, versus placebo (one single injection).
Baseline evaluation: Clinical evaluation with visual analog scale (VAS) for pain quantification, QoL assessment with standardized questionnaires, voiding diary with the recording of diurnal and nocturnal urinary frequency; urodynamic evaluation, 1 month before commencing the study.
Treatment: According to a randomization computerized system, patients will receive: A) one single injection of botulin a toxin, 150 U diluted in 15 ml normal saline into the bladder, under cystoscopy guidance, under local anesthesia ; or B) one single bladder over distension under local anesthesia. C) one single injection of placebo (na cl 0.9 % 150 ml) under local anesthesia.
Follow up: clinical evaluation (VAS, qol assessment, voiding diary) and urodynamics tree months after treatment.
Primary outcome: clinical efficacy in term of pain relief, amelioration of diurnal and nocturnal urinary frequency and QoL improvement. Safety with the recording of local and systemic side effects.
Secondary outcomes: increase in cystometric capacity on urodynamics.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Painful Bladder Syndrome (PBS)
Intravesical injection of Botulinum A toxin, Bladder overdistension, Placebo
University Of Perugia
Enrolling by invitation
University Of Perugia
Published on BioPortfolio: 2014-08-27T03:12:24-0400
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