Intravesical injection of botulinum toxin A in patients with refractory interstitial cystitis/ painful bladder syndrome
Phase 2
- Conditions
- Interstitial cystitis/ Painful bladder syndrome (IC/ PBS)
- Registration Number
- JPRN-UMIN000004554
- Lead Sponsor
- Department of Urology, Unversity of Tokyo hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
12
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjects are randomized into 2 groups;one is group who will be treated soon after the enrollment, the other will be observed with present therapy for a month, then treated. The primary end point of this study will be the Global response assessment score in these two groups.
- Secondary Outcome Measures
Name Time Method 1.Duration of symptom relief 2.Changes during 12 months after the therapy 1)flow volume chart 2)O'Leary and Sants' symptom index and problem index 3)Visual analogue scale for pain 4)over active bladder symptom score 5)International prostate symptom score 6)Core lower urinary tract symptom score 7)QOL score 8)Global response assessment score