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

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ClinicalTrials.gov 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
Sponsor:
Information provided by:
University Of Perugia

Tracking Information
First Submitted Date  ICMJE February 1, 2010
First Posted Date  ICMJE July 7, 2010
Last Update Posted Date April 20, 2011
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire). [ Time Frame: PAIN quantification with 3 months follow up ]
Change History Complete list of historical versions of study NCT01157507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2010)
Urodynamic assessment [ Time Frame: 3 months follow up ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome
Official Title  ICMJE Botulinum A Toxin Intravesical Injections Versus Bladder Overdistension in the Treatment of Patients With Painful Bladder Syndrome: A Prospective Randomized Study
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Painful Bladder Syndrome (PBS)
Intervention  ICMJE
  • 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
  • Drug: Placebo
    One single injection of placebo
    Other Name: One single injection of placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 6, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2011
Estimated Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • neurological diseases
  • pregnancy and concomitant use of aminoglycosides and anticoagulants
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01157507
Other Study ID Numbers  ICMJE MA-B-PD-P
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Giannantoni Antonella, University of Perugia
Study Sponsor  ICMJE University Of Perugia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Of Perugia
Verification Date December 2009

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