Track topics on Twitter Track topics that are important to you
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
We hypothesize that LESWs might temporarily increase urothelial permeability and facilitate delivery of intravesical botulinum toxin without the need for injection.
The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive ...
The purpose of this research study is to evaluate the efficacy of intravesical botulinum A toxin and DMSO in women with bladder pain syndrome who have not responded to first-line treatment...
There is no consensus of the therapeutic efficacy and safety between suburothelial injection and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial cystitis/blad...
The purpose of this study is to examine how injection of botulinum toxin in the bladder affects bladder function. The trial is carried out in children born with malformation of the spinal ...
The aim of the study was to estimated the clinical efficacy of intravesical injections of botulinum toxin type A (BTX-A) in refractory idiopathic overactive bladder (OAB) in the aspect of the quality ...
To investigate the efficacy and safety of non-invasive intravesical instillation of OBTX-A through systematic review and meta-analysis. Recently, several studies of non-invasive intravesical instillat...
Intravesical injection with onabotulinum toxin A (BTX-A) injection can be performed in-office under local anesthesia. Rectally administered pain medication presents a potentially feasible and previous...
Prior to FDA approval of intradetrusor botulinum toxin (BoTA) injections for the treatment of neurogenic bladder, patients had limited treatment options including 'off-label' use of pharmacotherapies ...
At sufficient dose, intramuscular injection of Botulinum toxin A causes muscle wasting that is physiologically consistent with surgical denervation and other types of neuromuscular dysfunction. The ai...
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type C which is neurotoxic to ANIMALS, especially CATTLE, but not humans. It causes dissociation of ACTIN FILAMENTS.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type D which is neurotoxic to ANIMALS, especially CATTLE, but not humans.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type B which is neurotoxic to humans and animals.
Subtype of CLOSTRIDIUM BOTULINUM that produces botulinum toxin type E which is neurotoxic to humans and animals.
Subtype of CLOSTRIDIUM BOTULINUM that produces BOTULINUM TOXIN TYPE A which is neurotoxic to humans and animals.
Benign Prostatic Hyperplasia (BPH) Erectile Dysfunction Urology Urology is the branch of medicine concerned with the urinary tract and diseases that affect it. Examples include urethritis, urethrostenosis and incontinence. Urology is a su...
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...