Botox as a Treatment for Interstitial Cystitis in Women
Condition: Painful Bladder Syndrome; Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: Botox; normal saline
Intervention description: Botox 25 international units per injection injected in two places in the bladder neck, with option to inject two other tender points with 25 units each; Normal saline injected into the bladder neck via the perineum, 1 cc each given at positions 3 o'clock and 9 o'clock
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with interstitial cystitis have been well documented to have pelvic floor muscle
      tenderness as well as pain on bladder distension. Some investigators have even suggested that
      pelvic floor muscle pain is primarily the cause of bladder problems.

      Botulinum toxin A causes muscle relaxation by inhibiting the acetylcholine release at the
      neuromuscular junction. It has been shown that this mechanism relieves pain in a number of
      muscle spasm-related syndromes.

      Because, at present, there is little effective therapy available for patients with
      interstitial cystitis, the researchers want to determine if botulinum toxin A will relieve
      bladder and pelvic pain in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ages 18 and older

          -  Diagnosis of interstitial cystitis

          -  Subject has severity/stage of disease: at least 12 voids/day with the presence of
             pelvic pain

          -  Ability to follow study instructions and likely to complete all required visits.

          -  Negative urine pregnancy test on the day of treatment prior to the administration of
             study medication (for females of childbearing potential; if applicable)

        Exclusion Criteria:

          -  Use of any medications that might interfere with neuromuscular function

          -  Any medical condition that may put the subject at increased risk with exposure to
             Botox including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
             lateral sclerosis, or any other disorder that might interfere with neuromuscular
             function

          -  Females who are pregnant, breast-feeding, or planning a pregnancy during the study or
             who think that they may be pregnant at the start of the study, or females of
             childbearing potential who are unable or unwilling to use a reliable form of
             contraception during the study

          -  Known allergy or sensitivity to any of the components in the study medication

          -  Concurrent participation in another investigational drug or device study, or
             participation in the 30 days immediately prior to study enrollment.

          -  Stress incontinence

          -  Urinary tract infection at time of enrollment

          -  Overtly psychotic or suicidal

          -  Pain from another source in the genital tract such as kidney stones or neoplasm

          -  Having had radiation therapy

          -  History of genitourinary tuberculosis

          -  Neurological abnormalities such as stroke, brain tumors, spinal cord injury and
             Parkinson's or Alzheimer's disease

          -  Currently taking antibiotics