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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Painful Bladder Syndrome (PBS)

Intervention / Treatment
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* Drug: Intravesical injection of Botulinum A Toxin
* Procedure: Bladder overdistension
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: refractory bladder pain, the urgency-frequency syndrome, and sterile urine Exclusion Criteria: neurological diseases pregnancy and concomitant use of aminoglycosides and anticoagulants

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Botulinum A toxin<br>Botulinum A toxin intravesical injection. | Drug: Intravesical injection of Botulinum A Toxin<br>* One treatment, 100 U vials diluted in 10 ml normal saline<br>* Other names: Allergan;|
| Sham Comparator: Bladder overdistension<br>Standard treatment: bladder overdistension | Procedure: Bladder overdistension<br>* Bladder overdistension<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* One single injection of placebo<br>* Other names: One single injection of placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urodynamic assessment |  | 3 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum A toxin, Painful Bladder Syndrome (PBS), Bladder overdistention