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

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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 μM or 0.10 μM 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 μM RTX, eight in 0.05 μM 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 μM and 0.05 μM.

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Authors and Affiliations

  1. Centre Hospitalier Universitaire de Sherbrooke, Université de Sherbrooke, Service d’urologie 3001, 12e ave Nord, Fleurimont (Qc), J1H 5N4, Canada

    Tony YH Chen, Michel Camel, Yves Ponsot & Le Mai Tu

  2. Jewish General Hospital, McGill University, Montreal, Canada

    Jacques Corcos

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  1. Tony YH Chen
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  2. Jacques Corcos
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  3. Michel Camel
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Correspondence to Tony YH Chen.

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Chen, T.Y., Corcos, J., Camel, M. et al. Prospective, randomized, double-blind study of safety and tolerability of intravesical resiniferatoxin (RTX) in interstitial cystitis (IC). Int Urogynecol J 16, 293–297 (2005). https://doi.org/10.1007/s00192-005-1307-4

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  • DOI: https://doi.org/10.1007/s00192-005-1307-4

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