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[Assessment of effectiveness of and tolerance to oxybutynin in the treatment of unstable bladder in women]

Author(s): Serrano Brambila EA, Quiroga Avila RG, Lorenzo Monterrubio JL, Moreno Aranda J

Affiliation(s): Departamento de Urodinamia, Hospital de Especialidades del Centro Medico Nacional Siglo XXI.

Publication date & source: 2000-04, Ginecol Obstet Mex., 68:174-81.

Publication type: Clinical Trial; Randomized Controlled Trial

Unstable bladder is a frequent syndrome in women and is due in the most part because of detrusor involuntary contractions, mainly due to detrusor denervation, which produces voiding hypersensitivity and loss of cortical inhibition control, clinical manifestations are: frequency, nicturia, urgency and urge incontinence. Historically the most effective treatment has been muscular relaxing agents and anticholinergic agents. We present a prospective, double blind, cross, placebo control study to evaluate efficacy and tolerance of oxybutynin in women with unstable bladder. We included 44 adult women with unstable bladder, 22 unitially received oxybutynin 5 mg t.i.d. and 22 placebo 5 mg t.i.d. aleatory in both groups through 6 weeks, later wash-out period was performed and those women in which initially received oxybutynin were administered placebo and those women in which initially received placebo, were administered oxybutynin, for another six weeks. Five patients which initiated the study with oxybutynin abandoned the study, 2 of them for intolerance and 3 for unknown causes. Two women in which initially received placebo abandoned follow-up too. A total of 74 subjects (37 for each branch of study) had an age average of 51.7. Symptoms scoring decreased from 13 to 11 and 6 points with placebo and oxybutynin respectively (p = 0.001). The analog visual scale of symptoms decreased from 77% to 62.5% and 40% with placebo and oxybutynin respectively (p = 0.003). The overall rate of improvement evaluated through symptoms scoring was from 27% with placebo and 72.9% with oxybutynin (p = 0.000) and evaluated through analog visual scale of symptoms was from 40% with placebo and 78.3% with oxybutynin (p = 0.002). The vesical volume at first voiding sensation increased from 129 ml to 134 ml and 187 ml with placebo and oxybutynin respectively (p = 0.021) and the maximum cystometric capacity increased from 231 ml to 236 ml and 301 ml with placebo and oxybutynin respectively. The most frequent adverse effect in both groups was mouth dryness and it presented in 7 (19%) and 34 (91%) patients with placebo and oxybutynin respectively (p = 0.000). Only 5 of 44 patients (11.3%) with oxybutynin and 2 of 44 patients (4.4%) with placebo abandoned follow up (p = 0.14). We concluded that oxybutynin improve significantly the unstable bladder symptoms in women, possibly by increasing functional bladder capacity and decreasing voiding sensitivity, with good tolerance of mouth dryness in the majority of patients.

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