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

• ClinicalTrials.gov Identifier: NCT01157507
• Recruitment Status: Unknown
• First Posted: July 7, 2010
• Last Update Posted: April 20, 2011
• Sponsor: University Of Perugia
• Information provided by: University Of Perugia

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes 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

Locations

Italy

University Of Perugia

Perugia, Italy, 16100

Sponsors and Collaborators

University Of Perugia

More Information

• Responsible Party: Giannantoni Antonella, University of Perugia
• ClinicalTrials.gov Identifier: NCT01157507
• Other Study ID Numbers: MA-B-PD-P
• First Posted: July 7, 2010
• 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:

Cystitis, Interstitial; Syndrome; Pain; Disease; Pathologic Processes; Neurologic Manifestations; Cystitis; Urinary Bladder Diseases; Urologic Diseases; Botulinum Toxins, Type A; abobotulinumtoxinA; 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