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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2007-005164-27-NL |
Date of registration:
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17/10/2007 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/
Interstitial Cystitis
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Scientific title:
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Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/
Interstitial Cystitis
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Date of first enrolment:
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22/02/2008 |
Target sample size:
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12 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005164-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Netherlands
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Key inclusion & exclusion criteria
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Inclusion criteria: -Males and females aged 18 years, or older -Written informed consent has been obtained from the subject -Subject is able to fill in voiding diary and questionnaire -Subject has BPS/IC for a period of at least 9 months prior to screening, as determined by patient history: - patient had cystoscopy with hydrodistension and cold biopsy - patient has used oral medication: anticholinergic, NSAID and tricyclic antidepressant - patient has used intravesical instillations with cystistat, or ura-cyst, or bladder cocktails, or heparin, or oxybutinin -Subject has Visual Analog Scale (VAS) more than 5 -Those subjects taking anticholinergic medication, NSAID or tricyclic antidepressant use a stable dose and they are willing to maintain the dose during the study - Patients must be willing to use clean intermittent catheterization to empty the bladder Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria: - Patient is pregnant, or patients who want to become pregnant during the study - Patient has an active urinary tract infection or recurrent urinary tract infections ( > 5 urinary tract infections a year) - Patient has a chronic or bacterial prostatitis - Patient has a vaginitis - Patient has an active sexually transmitted diseases - Patient has bladder stones or urolithiasis - Patient has an urethra or bladder diverticulum - Patient has carcinoma of the uterus, cervix, vagina, urethra or prostate - Patient has carcinoma in situ / malignancy of the bladder - Patient has chemical-, tuberculous- or radiation cystitis - Patient has hemophilia or other clotting factor deficiencies or disorders that cause bleeding diatheses. - Patient has any medical condition that may put the patient at increased risk with exposure to BTX-A including diagnosed myasthenia gravis, Eaton Lambert syndrome or amyotrophic lateral sclerosis - Patient discontinued anticholinergic, NSAID or antidepressant medication for bladder pain < 14 days prior to screening - Patient using intravesical instillations, or used it 4 weeks prior to screening - Patient using neuromodulations devices for treatment of BPS/IC - Patient is breastfeeding - Patient has a post void residual volume above 200 ml - Patients who will use neuromuscular blocking agents in the period of three days before until eight weeks after study treatment - Patients who will use aminoglycoside antibiotics the period of three days before until eight weeks after study treatment
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis (IC) is a syndrome characterized by bladder pain associated with urgency, frequency, nocturia, dysuria and sterile urine. The patho-physiology remains largely unclear. No universally, effective, treatment exists.
Botulinum toxin-A (BTX-A) inhibits the release of acetylcholine at the presynaptic cholinergic junction resulting in temporally muscle relaxation and bladder desensitisation. We explore the effects of intravesical injections with BTX-A in the treatment of IC.
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Intervention(s)
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Trade Name: Botox Pharmaceutical Form: Concentrate for solution for injection
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Primary Outcome(s)
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Primary end point(s): The change in score on Visual Analog Scale (VAS) of the McGill Pain Questionnaire Dutch Language Version (MPQ-DLV) between baseline and six weeks after treatment with Botox®.
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Main Objective: To describe the course of Bladder Pain Syndrome/ Interstitial Cystitis after intravesical injections of botulinum toxin A.
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Secondary Objective:
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Source(s) of Monetary Support
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Results
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Results available:
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