Abstract | PURPOSE: We evaluated safety and efficacy outcomes in a case series of subjects who received open label intravesical bacillus Calmette-Guerin after failing to respond to bacillus Calmette-Guerin or intravesical placebo in a randomized clinical trial. MATERIALS AND METHODS: Subjects who met National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases criteria for IC and reported at least moderate pain and frequency were initially randomized to 6 weekly intravesical instillations of bacillus Calmette-Guerin or placebo and followed for a total of 34 weeks. At 34 weeks subjects who reported that they had not responded to treatment were offered treatment with open label bacillus Calmette-Guerin, using the same course of treatment and followup. Outcomes included a patient reported global response assessment, a 24-hour voiding diary, pain, urgency, validated interstitial cystitis symptom indexes and adverse events. RESULTS: A total of 156 subjects elected open label bacillus Calmette-Guerin, of whom 18 (12%) withdrew during the open label series. The response rate based on the global response assessment was 18% and it was identical between those initially randomized to placebo (first course of bacillus Calmette-Guerin in the open label series) and those initially randomized to bacillus Calmette-Guerin (second course). Small improvements were observed for most secondary efficacy outcomes. Most participants reported at least 1 adverse event, primarily pain, genitourinary symptoms and gastrointestinal disturbances. However, there was no difference in adverse events between those who received the first course of bacillus Calmette-Guerin in this series compared to those who received 2 courses. CONCLUSIONS: The low response rate for bacillus Calmette-Guerin in this open label case series further argues against the routine use of bacillus Calmette-Guerin as treatment for interstitial cystitis.
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Authors | Kathleen Joy Propert, Robert Mayer, J Curtis Nickel, Christopher K Payne, Kenneth M Peters, Valerie Teal, David Burks, John W Kusek, Leroy M Nyberg, Harris E Foster, Interstitial Cystitis Clinical Trials Group |
Journal | The Journal of urology
(J Urol)
Vol. 178
Issue 3 Pt 1
Pg. 886-90
(Sep 2007)
ISSN: 0022-5347 [Print] United States |
PMID | 17631335
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural)
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Chemical References |
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Topics |
- Administration, Intravesical
- Adult
- Aged
- Aged, 80 and over
- BCG Vaccine
(administration & dosage, adverse effects)
- Cystitis, Interstitial
(drug therapy)
- Female
- Humans
- Male
- Middle Aged
- Retreatment
- Treatment Outcome
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