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

Painful Bladder Syndrome (PBS) Clinical Trial

Official title:

Botulinum A Toxin Intravesical Injections Versus Bladder Overdistension in the Treatment of Patients With Painful Bladder Syndrome: A Prospective Randomized Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01157507
• Other study ID #: MA-B-PD-P
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: February 1, 2010
• Last updated: April 19, 2011
• Start date: January 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2009
• Source: University Of Perugia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis, Interstitial
• Pain
• Painful Bladder Syndrome (PBS)
• Syndrome

Intervention

Drug:
• Intravesical injection of Botulinum A Toxin
One treatment, 100 U vials diluted in 10 ml normal saline

Procedure:
• Bladder overdistension
Bladder overdistension

Drug:
• Placebo
One single injection of placebo

Locations

Country	Name	City	State
Italy	University Of Perugia	Perugia

Sponsors (1)

Lead Sponsor	Collaborator
University Of Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Urodynamic assessment		3 months follow up	Yes