Intravesicular Onabotulinumtoxin A in Interstitial Cystitis
Condition: Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Onabotulinumtoxin A; injections upper aspect of trigone of urinary bladder; injections on posterior bladder wall excluding the trigone
Intervention description: 100 units of botox spread out among 10 separate injections; We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.; We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: women; interstitial cystitis; bladder pain syndrome; botox; onabotulinum toxin A

Summary:

      The purpose of this research study is to identify the optimal usage of Onabotulinumtoxin A in
      interstitial cystitis. Onabotulinumtoxin A, more commonly known by the trade name Botox®, is
      a medication that comes from the bacteria Clostridium botulinum. It works by blocking the
      release of the neurotransmitter acetylcholine(a chemical messenger that carries signals
      between nerve cells and other cells in the body). Blocking that neurotransmitter results in
      decreased muscle activity.
    

Eligibility criteria:

        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