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

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 12

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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®.

Secondary Outcome Measures

Name	Time	Method

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