E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To describe the course of Bladder Pain Syndrome/ Interstitial Cystitis after intravesical injections of botulinum toxin A. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |