Patient‐selected goals in overactive bladder: a placebo controlled randomized double‐blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence

Study Type – Therapy (RCT)
Level of Evidence 1b What’s k n own on the subject? and What does the study add? In common with other anticholinergics, transdermal oxybutynin improves symptoms, and disease specific quality of life for patients with urgency incontinence. Achievement of patient selected goals for treatment of overactive bladder has also been demonstrated in uncontrolled studies. Over a four week period, transdermal oxybutynin improved urinary urgency for patients with overactive bladder, including those without incontinence. However, in comparison to placebo it did not lead to significant achievement of patients’ own therapeutic goals.

OBJECTIVE

To assess patient selected goal improvement with transdermal oxybutynin, in a representative population of adult women with overactive bladder (OAB).

SUBJECTS AND METHODS

Adult women with ≥3 month history of OAB symptoms, with or without urgency urinary incontinence, were recruited from a tertiary referral urogynaecology unit. Participants were allocated to either transdermal oxybutynin 3.9 mg/day or matching placebo patches in a double‐blind, randomized parallel group design, over 4 weeks. Patient‐selected goal achievement was defined as the primary outcome measure. Participants selected their own goals for treatment at baseline, and subsequently scored achievement of these goals on a visual analogue scale. They completed 3‐day bladder diaries incorporating the Patients Perception of Intensity of Urgency Scale (PPIUS) to assess urgency and urgency incontinence episodes. Quality of life was assessed using the King’s Health Questionnaire (KHQ).

RESULTS

A total of 96 women were randomized; 78 (81.3%) participants completed 4 weeks double‐blind treatment. There was no significant difference between mean goal achievement in the transdermal oxybutynin and placebo groups (41.9% (SD 31.3) vs 32.2% (SD 27.3), P= 0.203). Transdermal oxybutynin was associated with significant improvements in urgency episodes (?1.23 episodes/day (SD1.40) vs ?0.21 episodes/day (SD 1.58), P= 0.01). Both groups made non‐significantly different improvements in KHQ scores; 18 (38.2%) patients in the transdermal oxybutynin group experienced either erythema or pruritus, with 7 (14.9%) experiencing at least one systemic adverse event.

CONCLUSIONS

In women with OAB, in comparison with placebo, transdermal oxybutynin 3.9 mg/day leads to significant objective improvements in urinary urgency, but with no significant difference observed in achievement of patients’ own goals for therapy, or improvement in disease specific quality of life.