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Int Urogynecol J Pelvic Floor Dysfunct. 2005 Jul-Aug;16(4):293-7. Epub 2005 Apr 8.

Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC).

Author information

1
Centre Hospitalier Universitaire de Sherbrooke, Service d'urologie 3001, Canada. tony.chen@mail.mcgill.ca

Abstract

OBJECTIVE:

To determine the safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC) patients.

MATERIALS AND METHODS:

IC patients were instilled with 50 cc of test solution containing either placebo, 0.05 microM or 0.10 microM RTX in the bladder. Plasma concentration of RTX and its degradant resiniferonol 9-, 13-, 14-orthophenylacetate was measured. Immediate post-treatment blood sampling and cystoscopy were performed. Symptoms were evaluated before treatment, at 4- and at 12-week follow-ups, using VAS indicator for pain, voiding diary, and O'Leary's IC symptom/problem indices.

RESULTS:

Among 22 patients observed (ten in 0.10 microM RTX, eight in 0.05 microM RTX, and four in placebo groups), the most commonly reported adverse event was pain during instillation (80.0%, 87.5%, and 25.0%). No serious adverse events were reported.

CONCLUSIONS:

Use of intravesical RTX in IC patients is associated with important tolerability issues but safe at 0.10 microM and 0.05 microM.

PMID:
15818465
DOI:
10.1007/s00192-005-1307-4
[Indexed for MEDLINE]
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