Botulinum a Toxin to Treat Patients With Painful Bladder Syndrome

2014-08-27 03:12:24 | BioPortfolio


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.

Study Design

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

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:12:24-0400

Clinical Trials [2053 Associated Clinical Trials listed on BioPortfolio]

Delivery of Intravesical Botulinum Toxin A Using Low Energy Shock Waves in Treatment of Overactive Bladder: A Feasibility Study

We hypothesize that LESWs might temporarily increase urothelial permeability and facilitate delivery of intravesical botulinum toxin without the need for injection.

Evaluation of Botulinum Toxin A Alone Versus Botulinum Toxin A With Hydrodistension for Treatment of Overactive Bladder

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 ...

Comparison of the Treatment of Refractory Bladder Pain Syndrome With DMSO and DMSO With Botulinum Toxin A

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...

Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis

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...

Effect of Botulinum Toxin in Neurogenic Bladders in Children With Myelomeningocele

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 ...

PubMed Articles [4435 Associated PubMed Articles listed on BioPortfolio]

Assessing adverse effects of intra-articular botulinum toxin A in healthy Beagle dogs: A placebo-controlled, blinded, randomized trial.

To investigate the clinical, cytological, and histopathological adverse effects of intra-articularly injected botulinum toxin A in dogs and to study whether the toxin spreads from the joint after the ...

Primary treatment of early fistula of parotid duct with botulinum toxin type A injection.

Salivary duct injury can be idiopathic, iatrogenic, or post-trauma and may result in sialocele or fistula. Most injuries regress spontaneously and botulinum toxin A is one of several therapeutic possi...

Inconsistency in the definition of urinary tract infection after intravesical botulinum toxin A injection: a systematic review.

In order to more accurately examine the rate of urinary tract infection following onabotulinumtoxinA injection of the bladder, we systematically reviewed the literature for definitions of urinary trac...

Randomized Controlled Trial of Belladonna and Opiate Suppository during Intravesical Onabotulinum Toxin A Injection.

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...

Comparative study of efficacy and safety between bladder body and trigonal intravesical onabotulinumtoxina injection in the treatment of interstitial cystitis refractory to conventional treatment-A prospective, randomized, clinical trial.

Intravesical onabotulinumtoxinA (BoNT-A) injection can relieve symptoms of interstitial cystitis/bladder pain syndrome (IC/BPS). However, the therapeutic efficacy of different injection sites is not w...

Medical and Biotech [MESH] Definitions

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 A 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 F which is neurotoxic to humans and animals.

More From BioPortfolio on "Botulinum a Toxin to Treat Patients With Painful Bladder Syndrome"

Quick Search


Relevant Topics

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...

Searches Linking to this Trial