Botulinum Toxin A (BTXA) versus Hydrodistension for Refractory Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)- a Multicentre, Prospective, Randomized, Double Blind Study
Phase 2
Completed
- Conditions
- interstitial cystitis/painful bladder syndromeRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12612000216819
- Lead Sponsor
- John Hunter Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 50
Inclusion Criteria
Female, chronic, refractory interstitial cystitis, painful bladder syndrome
Exclusion Criteria
urinary tract infection
pregnancy
systemic steroid use
cancer
voiding impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method improvement in Oleary Sant scores problem and symptom. O'leary Sant scoring is a validated , well recognized measure of the impact upon a patient of Interstitial cystitis symptoms and problems that they experience[3 months]
- Secondary Outcome Measures
Name Time Method diary data. This data asseses patient maximum voided volume, patient averaged voided volume. Frequency of voiding during the day, frequency of voiding at night[3 months];patient global impression improvement. This is a standardised, validated questionnaire patients will complete[3 months];patient global impression severity. This is a standardised, validated questionnaire patients will complete[3 months];urodynamic data. This is a standardised test that will collect the following information; peak flow rate,voided volume, residual post void volume left in bladder, maximum filling capacity, bladder compliance (pressure rise in cm H20 for a volume of fluid instilled) . Incontinence if it occurs.[3 months];urge incontinence impact questionnaire data. This is a standardised, validated questionnaire patients will complete measuring specifically symptoms of urinary urgency[3 months]