Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions

Abstract

Aims: Overactive bladder (OAB) is common in men and may exist concomitantly with benign prostatic hyperplasia (BPH) and obstruction. We present a subanalysis of results from men with OAB in a 6-month, open-label study of treatment with the oxybutynin transdermal system (OXY-TDS). Broad entry criteria were incorporated to yield a clinically representative population.

Methods: All participants received OXY-TDS 3.9 mg/day. Effectiveness was assessed by changes in scores on validated questionnaires, which included the single-item Patient Perception of Bladder Condition (PPBC), the King's Health Questionnaire (KHQ) and the Beck Depression Inventory-II (BDI-II).

Results: The proportion of men (n=369; mean age=69.6 years) who reported that their bladder condition caused moderate, severe or many severe problems (PPBC>or=4) improved from 77.3% at baseline to 38.1-53.6% in subsequent months. Mean KHQ scores decreased significantly (p<or=0.0196) from baseline to study end in eight of 10 domains, indicating improved health-related quality of life. The proportion of men with BDI-II score>12 (associated with a diagnosis of depression) decreased from 23.9% to 17.9% (p=0.0055). Men with a history of 'prostate problems' or use of 'BPH medication' (32.2%) had KHQ domain changes that were similar (p>or=0.1016) to those of other men. Most men (76.2%) reported no treatment-related adverse events; two men (0.5%) experienced symptoms of mild urinary retention, but neither required catheterisation.

Conclusions: Oxybutynin transdermal system treatment of men with OAB was effective and well tolerated, regardless of history of prostate condition.

Figures

Figure 1

Participant-reported measures of bladder condition; percentages are calculated on the basis of the total number of respondents at each evaluation. (A) Percentage of respondents who rated their global overactive bladder (OAB) severity as 1, 2 or 3 (no problems at all, very minor problems or some very minor problems) or 4, 5 or 6 (moderate problems, severe problems or many severe problems) with the Patient Perception of Bladder Condition (PPBC) questionnaire. (B) Percentage of respondents who reported feeling that they had enough time to get to the bathroom during the past month

Figure 2

Health-related quality of life (HRQoL) of male participants at baseline and at study end, assessed as mean King's Health Questionnaire (KHQ) domain scores. *p t-test for significance of difference from zero for change in baseline value; other changes were not statistically significant (p ≥ 0.1033)

Figure 3

Percentage of male participants who reported improvement or worsening, from baseline to study end, in symptoms described in individual King's Health Questionnaire (KHQ) response items. Participants who reported that their symptoms ‘stayed the same’ are not depicted. Only responses for which statistically significant differences were noted are displayed. *p

Figure 4

Improvement in health-related quality of life (HRQoL) in men with and without pre-existing prostate problems, assessed as mean changes in King's Health Questionnaire (KHQ) domain scores from baseline to study end. All changes in score were similar between the two groups (p ≥ 0.1016); analysis of co-variance (ANCOVA)

Figure 5

Participant-reported satisfaction with oxybutynin transdermal system (OXY-TDS) treatment; percentages are calculated on the basis of the total number of respondents at each evaluation. (A) Overall satisfaction in the total population of male participants. (B) Overall satisfaction in male participants who had been treated before for overactive bladder (OAB)