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.
Conditions
Interventions
Trade Name: Botox
Pharmaceutical Form: Concentrate for solution for injection
Sponsors
research office urology VUmc
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the course of Bladder Pain Syndrome/ Interstitial Cystitis after intravesical injections of botulinum toxin A.;Secondary Objective: ;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®. | — |
Countries
Netherlands
Outcome results
None listed