At a glance
ClinicalIndex Comparison Record- ✓Women age 18 or older
- ✓Confirmed diagnosis of interstitial cystitis
- ✓At least 12 voids per day with presence of pelvic pain
- ✓Able to follow study instructions and complete all required visits
- ✕Use of medications that interfere with neuromuscular function
- ✕Diagnosed neuromuscular disorders: myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or other disorders affecting neuromuscular function
- ✕Stress incontinence
- ✕Active urinary tract infection at enrollment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Botox (Botulinum Toxin A) as a Treatment for Interstitial Cystitis in Women: A Randomized Placebo Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Botox and normal saline for Painful Bladder Syndrome and Interstitial Cystitis. Completed, enrolled 20 participants.
Detailed 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.
Study Details
Timeline
Interventions
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