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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT01157507
First received: February 1, 2010
Last updated: April 19, 2011
Last verified: December 2009

February 1, 2010
April 19, 2011
January 2010
September 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire). [ Time Frame: PAIN quantification with 3 months follow up ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01157507 on ClinicalTrials.gov Archive Site
Urodynamic assessment [ Time Frame: 3 months follow up ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome
Botulinum A Toxin Intravesical Injections Versus Bladder Overdistension in the Treatment of Patients With Painful Bladder Syndrome: A Prospective Randomized Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Painful Bladder Syndrome (PBS)
  • Drug: Intravesical injection of Botulinum A Toxin
    One treatment, 100 U vials diluted in 10 ml normal saline
    Other Name: Allergan
  • Procedure: Bladder overdistension
    Bladder overdistension
    Other Name: Bladder overdistension
  • Drug: Placebo
    One single injection of placebo
    Other Name: One single injection of placebo
  • Active Comparator: Botulinum A toxin
    Botulinum A toxin intravesical injection.
    Intervention: Drug: Intravesical injection of Botulinum A Toxin
  • Sham Comparator: Bladder overdistension
    Standard treatment: bladder overdistension
    Intervention: Procedure: Bladder overdistension
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • neurological diseases
  • pregnancy and concomitant use of aminoglycosides and anticoagulants
Female
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01157507
MA-B-PD-P
Yes
Giannantoni Antonella, University of Perugia
University Of Perugia
Not Provided
Not Provided
University Of Perugia
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP