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Clinical Trials/EUCTR2007-005164-27-NL
EUCTR2007-005164-27-NL
Active, Not Recruiting
N/A

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

research office urology VUmc0 sites12 target enrollmentOctober 17, 2007
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ConditionsInterstitial 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.
DrugsBotox

Overview

Phase
N/A
Intervention
Not specified
Conditions
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.
Sponsor
research office urology VUmc
Enrollment
12
Status
Active, Not Recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 17, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
research office urology VUmc

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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