Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome
Recruitment status was: Enrolling by invitation
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.
|Painful Bladder Syndrome (PBS)||Drug: Intravesical injection of Botulinum A Toxin Procedure: Bladder overdistension Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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|
- Clinical efficacy: reduction in pain and diurnal and nocturnal urinary frequency; improvement in QOL; improvement in HAM-A and HAM-D scores. [ Time Frame: PAIN quantification with 3 months follow up ]
- Urodynamic assessment [ Time Frame: 3 months follow up ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||September 2011|
|Estimated Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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 Name: Allergan
Sham Comparator: Bladder overdistension
Standard treatment: bladder overdistension
Procedure: Bladder overdistension
|Placebo Comparator: Placebo||
One single injection of placebo
Other Name: One single injection of placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157507
|University Of Perugia|
|Perugia, Italy, 16100|