Ignite Creation Date:
2024-05-05 @ 10:37 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01157507
Status:
UNKNOWN
Last Update Posted:
2011-04-20
First Post:
2010-02-01
Brief Title:
Botulinum A Toxin in the Treatment of Patients With Painful Bladder Syndrome
Sponsor:
University Of Perugia
Organization:
University Of Perugia
Study Overview
Official Title:
Botulinum A Toxin Intravesical Injections Versus Bladder Overdistension in the Treatment of Patients With Painful Bladder Syndrome A Prospective Randomized Study
Status:
UNKNOWN
Status Verified Date:
2009-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Previous clinical observations showed that Botulinum A toxin BoNTA 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 BoNTA intravesically administered
The aim of the study is to investigate the clinical and urodynamic effects of an intravesical treatment with BoNTA 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
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 BoNTA intravesically administered
The aim of the study is to investigate the clinical and urodynamic effects of an intravesical treatment with BoNTA 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
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 BoNTA 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 09 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
Treatment According to a computerized randomization patients will receive A one single injection of BoNTA 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 09 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None