Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/ Interstitial Cystitis

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-005164-27-NL
• Date of registration: 17/10/2007
• Prospective Registration: Yes
• Primary sponsor: research office urology VUmc
• Public title: Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/ Interstitial Cystitis
• Scientific title: Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/ Interstitial Cystitis
• Date of first enrolment: 22/02/2008
• Target sample size: 12
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-005164-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Trade Name: Botox
Pharmaceutical Form: Concentrate for solution for injection

Primary Outcome(s)

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®.

Main Objective: To describe the course of Bladder Pain Syndrome/ Interstitial Cystitis after intravesical injections of botulinum toxin A.

Secondary Objective:

Secondary ID(s)

260981