Botox as a Treatment for Interstitial Cystitis in Women
Painful Bladder Syndrome, Interstitial Cystitis
About this trial
This is an interventional treatment trial for Painful Bladder Syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Botox injection
Normal saline
Subjects were injected with Botulinum toxin A in a mix of 50 U diluted in 2 cubic centimeters of normal saline. With the subjects in the dorsal lithotomy position, one injection of 25 international units was given into the bladder neck at the 3 o'clock position and another of 25 international units was given into the 9 o'clock position
Subjects were injected in the bladder neck with 1 cubic centimeter normal saline into the 3 o'clock and 6 o' clock positions in the perineum, while in the dorsal lithotomy position