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.

Study Overview

• Status: Unknown
• Conditions: Painful Bladder Syndrome (PBS)
• Intervention / Treatment: Drug: Intravesical injection of Botulinum A Toxin; Procedure: Bladder overdistension; Drug: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Perugia, Italy, 16100
    • University Of Perugia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; One single injection of placebo; Other Names: One single injection of placebo
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 Names: Allergan
Sham Comparator: Bladder overdistension; Standard treatment: bladder overdistension	Procedure: Bladder overdistension; Bladder overdistension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Urodynamic assessment	3 months follow up

Collaborators and Investigators

• Sponsor: University Of Perugia

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): September 1, 2011
• Study Completion (Anticipated): September 1, 2011

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: July 6, 2010
• First Posted (Estimate): July 7, 2010

Study Record Updates

• Last Update Posted (Estimate): April 20, 2011
• Last Update Submitted That Met QC Criteria: April 19, 2011
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: Botulinum A toxin; Painful Bladder Syndrome (PBS); Bladder overdistention
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease; Cystitis; Syndrome; Pain; Cystitis, Interstitial; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: MA-B-PD-P