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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Urodynamic assessment [ Time Frame: 3 months follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Bladder overdistension
Placebo Comparator: Placebo Drug: Placebo
One single injection of placebo
Other Name: One single injection of placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • neurological diseases
  • pregnancy and concomitant use of aminoglycosides and anticoagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01157507

Locations
Italy
University Of Perugia
Perugia, Italy, 16100
Sponsors and Collaborators
University Of Perugia
  More Information

No publications provided

Responsible Party: Giannantoni Antonella, University of Perugia
ClinicalTrials.gov Identifier: NCT01157507     History of Changes
Other Study ID Numbers: MA-B-PD-P
Study First Received: February 1, 2010
Last Updated: April 19, 2011
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University Of Perugia:
Botulinum A toxin
Painful Bladder Syndrome (PBS)
Bladder overdistention

Additional relevant MeSH terms:
Pain
Cystitis, Interstitial
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014