NL-OMON31587
Completed
Phase 2
Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/ Interstitial Cystitis. - Bladder Pain Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 12
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Males and females aged 18 years, or older
- •\- 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
- •\- Subject has daytime voiding frequency more than 7
- •\- Subject has night\-time voiding frequency more than 2
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 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
Outcomes
Primary Outcomes
Not specified
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Botulinum toxin A intravesical injections in the treatment of Bladder Pain Syndrome/Interstitial CystitisInterstitial 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.EUCTR2007-005164-27-NLresearch office urology VUmc12
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