Visit Our Patient Site >>

Oxytrol Logo

Efficacy

Oxytrol® For Women has a well established efficacy profile[10,11]


Combined with daily lifestyle modifications (timed urination, pelvic floor exercises, and fluid management), patients using transdermal oxybutynin 3.9 mg/day significantly reduced urge incontinence (UI),[10,11]one of the most bothersome symptoms of OAB[12]


In a 12-week, double-blind, randomized study with active and placebo controls in patients previously treated with anticholinergic medications for OAB, where both active and placebo control patients also adhered to specified daily lifestyle modifications[11*]

  • Daily median UI episodes were reduced by 75% with transdermal oxybutynin 3.9 mg/day (n=121) at Week 12, vs 50% with placebo patch(n=117); P=0.0137 vs placebo patch


OXY-TDS, oxybutynin transdermal system. PBO, placebo patch.

Adapted from Dmochowski, 2003[11]

Median episodes of daily UI episodes
Baseline: Transdermal oxybutynin 3.9 mg/day—4.0, placebo—4.0;
Week 12: Transdermal oxybutynin 3.9mg/day—1.0, placebo—2.0.

In a 12-week, double-blind, randomized, placebo-controlled study where both active and placebo control patients also adhered to specified daily lifestyle modifications[10‡]

  • Weekly median UI episodes were reduced by 61% with transdermal oxybutynin 3.9 mg/day (n=123) at Week 12, vs 50% with placebo patch (n=130); P=0.0165 vs placebo patch[10]

Transdermal oxybutynin significantly reduces urinary frequency[10]

  • Mean urinary frequency was reduced by 18% with transdermal oxybutynin 3.9 mg/day (n=123), vs 9% with placebo patch (n=130); P=0.0457 vs placebo patch[10*]

Daily mean frequency
Baseline: Transdermal oxybutynin 3.9 mg/day (n=123),—11.8; placebo (n=130),—12.4;
Week 12: Transdermal oxybutynin 3.9 mg/day,—9.5; placebo—10.7.

  • 50% reductions in incontinence episodes reported for both studies may reflect effectiveness
    of nonpharmacologic treatment measures all transdermal oxybutynin and placebo subjects
    were instructed to follow.[10,11]
  • §Data are from a US national telephone survey using a clinically validated interview and a
    follow-up nested study comparing OAB cases to sex- and age-matched controls. A sample
    of 5,204 adults ≥18 years of age and representative of the US population by sex, age, and
    geographical region was obtained.[3]
  • Study Descriptions
    2 phase 3 pivotal clinical trials were conducted. The following is a description of 2 trials:
  • * Study 1was a randomized, double-blind study of transdermal oxybutynin vs active and
    placebo controls conducted in 361 patients. The 12-week, double-blind treatment included
    transdermal oxybutynin 3.9 mg/day, an active comparator, and placebo. The majority of
    patients were Caucasian (95%) and female (93%) with a mean age of 64 years (range, 18
    to 89 years). Entry criteria required that all patients have urge or mixed incontinence (with a
    predominance of urge) and had achieved a beneficial response from the anticholinergic
    treatment they were using at the time of study entry. There was a washout period prior to
    the study. The patient's medical history and a urinary diary during the treatment-free baseline
    period confirmed the diagnosis of urge incontinence. Throughout the study, patients were
    instructed to continue nonpharmacologic treatment measures (eg, pelvic floor exercise,
    timed voiding, or other behavioral techniques) consistent with standard practices.[10]
  • Study 2 was a randomized, double-blind, placebo-controlled, parallel group study of 3 dose levels of transdermal oxybutynin conducted in 520 patients.[11] The 12-week, double-blind treatment included transdermal oxybutynin 3.9 mg/day or matching placebo. The majority of
    patients were Caucasian (91%) and female (92%) with a mean age of 61 years (range, 20
    to 88 years). Entry criteria required that patients have urge or mixed incontinence (with a
    predominance of urge), urge incontinence episodes of ≥10 per week, and ≥8 micturitions
    per day. The patient's medical history and a urinary diary during the treatment-free baseline
    period confirmed the diagnosis of urge incontinence. Approximately 22% of patients treated
    with transdermal oxybutynin 3.9 mg/day had no prior anticholinergic treatment. There was a
    washout period prior to the study. Throughout the study, patients were instructed to
    continue nonpharmacologic treatment measures (eg, pelvic floor exercise, timed voiding, or
    other behavioral techniques) consistent with standard practices.[11]