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

Sponsor

University Of Perugia (Other)

Overall Status

Unknown status

CT.gov ID

NCT01157507

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Jan 1, 2010

Anticipated Primary Completion Date :

Sep 1, 2011

Anticipated Study Completion Date :

Sep 1, 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 Names: 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 Names: One single injection of placebo

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 Names:

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 Names:

One single injection of placebo

Outcome Measures

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. [PAIN quantification with 3 months follow up]