Intravesical resiniferatoxin for the treatment of women with idiopathic detrusor overactivity and urgency incontinence: A single dose, 4 weeks, double-blind, randomized, placebo controlled trial.
OBJECTIVE
To assess the hypothesis that resiniferatoxin (RTX) can be useful in women with urgency incontinence and idiopathic detrusor overactivity (IDO), we conducted a prospective, double-blind, randomized, placebo-controlled, parallel trial comparing the effects of RTX and placebo.


METHODS
Fifty-eight patients were randomly assigned to receive a single intravesical dose of 100 ml of either RTX 50 nM or placebo. Safety and efficacy were evaluated over 4 weeks. The primary efficacy endpoints were voiding symptoms evaluated through the voiding diary. Secondary efficacy endpoint was urodynamic response. Quality of life was measured by the Kings' Health Questionnaire


RESULTS
Although improving trends were seen in both groups after the instillations, no statistically significant differences were found between the groups in any of the clinical or urodynamic parameters. RTX instillations were well tolerated with few and self-limited side-effects.


CONCLUSIONS
A single 50 nM intravesical dose of RTX was not better than placebo for the treatment of women with IDO and urgency incontinence.
Rios
Luis Augusto Seabra
LA
Department of Urology, Federal University of São Paulo, Paulista School of Medicine, São Paulo, Brazil. seabrarios@uol.com.br
Panhoca
Renato
R
Mattos
Demerval
D
Srugi
Miguel
M
Bruschini
Homero
H
D000283:Administration, Intravesical; D004224:Diterpenes / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004644:Emotions; D005260:Female; D006801:Humans; D009498:Neurotoxins / Q000008:administration & dosage / Q000627:therapeutic use; D010919:Placebos; D011788:Quality of Life; D012919:Social Behavior; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology; D014550:Urinary Incontinence, Stress / Q000188:drug therapy* / Q000523:psychology; D014554:Urination / Q000187:drug effects / Q000502:physiology
D004224:Diterpenes; D009498:Neurotoxins; D010919:Placebos; C024353:resiniferatoxin