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

NCT01157507 | Unknown Phase 4 DMC

• 1 other identifier: MA-B-PD-P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Bladder Syndrome (PBS)

Keywords

Botulinum A toxin; Painful Bladder Syndrome (PBS); Bladder overdistention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Urodynamic assessment

  3 months follow up

Study Arms (3)

Botulinum A toxin

ACTIVE COMPARATOR

Botulinum A toxin intravesical injection.

Drug: Intravesical injection of Botulinum A Toxin

Bladder overdistension

SHAM COMPARATOR

Standard treatment: bladder overdistension

Procedure: Bladder overdistension

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Intravesical injection of Botulinum A Toxin DRUG

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

Also known as: Allergan

Botulinum A toxin

Bladder overdistension PROCEDURE

Bladder overdistension

Bladder overdistension

Placebo DRUG

One single injection of placebo

Also known as: One single injection of placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Of Perugia: lead

Study Sites (1)

University Of Perugia

Perugia, Perugia, 16100, Italy

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Idoxuridine

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: July 7, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 20, 2011

Record last verified: 2009-12

Locations

IT (1)