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Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01157507
Recruitment Status : Unknown
Verified December 2009 by University Of Perugia.
Recruitment status was:  Enrolling by invitation
First Posted : July 7, 2010
Last Update Posted : April 20, 2011
Information provided by:
University Of Perugia

Brief Summary:

Previous clinical observations showed that Botulinum A toxin (BoNT/A) has also an antinociceptive effect and can control the neuropathic pain.

In the urologic field, recent in in vitro and in in vivo studies demonstrated that the neurotoxin is able to inhibit the release of several neurotransmitters from the bladder afferent fibers and urothelium. These neurotrasmitters as SP, CGRP, ATP, NGF and Prostaglandins are involved in neurogenic inflammation. Thus, it is reasonable to hypothesize that patients with affected by painful bladder syndrome (PBS) could benefit from BoNT/A intravesically administered.

The aim of the study is to investigate the clinical and urodynamic effects of an intravesical treatment with BoNT/A in patients affected by PBS associated with increased urinary frequency, who are refractory to conventional treatments. This treatment will be compared to bladder over distention, which is considered a conventional therapy.

Condition or disease Intervention/treatment Phase
Painful Bladder Syndrome (PBS) Drug: Intravesical injection of Botulinum A Toxin Procedure: Bladder overdistension Drug: Placebo Phase 4

Detailed Description:

Patients with refractory PBS will be prospectively enrolled in the study. Baseline evaluation: Clinical evaluation with visual analog scale (VAS) for pain quantification; QoL assessment with a standardized questionnaire, HAM-A and HAM-D scales for the evaluation of anxiety and depression; voiding diary with the recording of diurnal and nocturnal urinary frequency; urodynamic evaluation, 1 month before commencing the study.

Treatment: According to a computerized randomization, patients will receive: A) one single injection of BoNT/A, 100 U diluted in 10 ml normal saline into the bladder, under cystoscopic guidance, under local anesthesia ; or B) one single bladder overdistension under local anesthesia. C) one single injection of placebo (NACL 0.9 % 10 ml) under local anesthesia.

Follow up: clinical evaluation (VAS, HAM-A and HAM-D, QOL assessment, voiding diary) and urodynamics three months after treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Botulinum A Toxin Intravesical Injections Versus Bladder Overdistension in the Treatment of Patients With Painful Bladder Syndrome: A Prospective Randomized Study
Study Start Date : January 2010
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Active Comparator: Botulinum A toxin
Botulinum A toxin intravesical injection.
Drug: Intravesical injection of Botulinum A Toxin
One treatment, 100 U vials diluted in 10 ml normal saline
Other Name: Allergan

Sham Comparator: Bladder overdistension
Standard treatment: bladder overdistension
Procedure: Bladder overdistension
Bladder overdistension

Placebo Comparator: Placebo Drug: Placebo
One single injection of placebo
Other Name: One single injection of placebo

Primary Outcome Measures :
  1. Clinical efficacy: reduction in pain and diurnal and nocturnal urinary frequency; improvement in QOL; improvement in HAM-A and HAM-D scores. [ Time Frame: PAIN quantification with 3 months follow up ]

Secondary Outcome Measures :
  1. Urodynamic assessment [ Time Frame: 3 months follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • refractory bladder pain, the urgency-frequency syndrome, and sterile urine

Exclusion Criteria:

  • neurological diseases
  • pregnancy and concomitant use of aminoglycosides and anticoagulants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01157507

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University Of Perugia
Perugia, Italy, 16100
Sponsors and Collaborators
University Of Perugia
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Responsible Party: Giannantoni Antonella, University of Perugia Identifier: NCT01157507    
Other Study ID Numbers: MA-B-PD-P
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: April 20, 2011
Last Verified: December 2009
Keywords provided by University Of Perugia:
Botulinum A toxin
Painful Bladder Syndrome (PBS)
Bladder overdistention
Additional relevant MeSH terms:
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Cystitis, Interstitial
Pathologic Processes
Neurologic Manifestations
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents