Intravesicular Onabotulinumtoxin A in Interstitial Cystitis

The purpose of this study is to evaluate the efficacy of intravesicular Onabotulinumtoxin A
injections for the treatment of interstitial cystitis (IC). Specifically, we hypothesize that
trigonal Onabotulinumtoxin A injections is an effective treatment for IC and will result in
more subjective and objective symptom relief than posterior wall Onabotulinumtoxin A
injections.

Inclusion Criteria:

1. Adult females between the ages of 18 and 80 inclusive

2. Patients being treated for IC who are refractory to conservative management and oral
therapy.

3. willing and able to initiate catheterization post-treatment

Exclusion Criteria:

1. Any history of bladder cancer, uterine cancer, ovarian cancer, vaginal cancer,
urethral diverticulum, spinal cord injury, stroke, Parkinson's disease, multiple
sclerosis, spina bifida, cyclophosphamide treatment, radiation treatment to the
pelvis, bladder tuberculosis, genital herpes.

2. Currently on or requiring anti-platelet/anti-coagulant concomitant therapy or having
been on anti-platelet/ anti-coagulant therapy within the past 3 months

3. Pregnancy. Pregnancy is an absolute contraindication to undergoing these procedures.
Thus, as part of their normal pre-operative work up, which is standard of care,
pregnancy tests are administered if they are women of child-bearing age, are sexually
active, and are within 10 days of the normal menstrual period. If positive, they will
be excluded as they will not undergo the procedure.

4. An active urinary tract infection as shown during clean-catch urinalysis at screening
visit. Subject may be re-screened if UTI is successfully treated and urinalysis is
negative at rescreening.

5. A history of hypersensitivity or allergy to any botulinum toxin preparation

6. A post-void residual (PVR) urine volume >200mL at baseline

7. Treatment with botulinum toxin during the 12 week period prior to the trial