Interstitial cystitis/ Painful bladder syndrome (IC/ PBS)
Conditions
Interventions
Subjects will be treated soon after the randomization, then will have monthly follow up for 12months.
Subjects will be observed for a month with present therapy, then have BTX treatment. After the the
Sponsors
Department of Urology, Unversity of Tokyo hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. IC/ PBS patients whose age is between 20 and 80 years. 2. Those who can have informed consent. 3. Those whose VAS score is more than 4 points and both OSSI/ OSPI scores are more than 6 points despite of hydrodistension, oral administration and intravesical therapy at present institution.
Exclusion criteria
Exclusion criteria: 12
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed