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

NCT01157507 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-04-20

No results posted yet for this study

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.

Conditions

Painful Bladder Syndrome (PBS)

Interventions

DRUG

Intravesical injection of Botulinum A Toxin

One treatment, 100 U vials diluted in 10 ml normal saline

PROCEDURE

Bladder overdistension

DRUG

Placebo

One single injection of placebo

Sponsors & Collaborators

University Of Perugia
lead OTHER

Study Design

Allocation: RANDOMIZED
Purpose: TREATMENT
Masking: DOUBLE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 80 Years
Sex: FEMALE
Healthy Volunteers: No

Timeline & Regulatory

Start: 2010-01-31
Primary Completion: 2011-09-30
Completion: 2011-09-30

Countries

Italy

Study Locations

More Related Trials

Entities

Drugs

Placebo