Interventions do not enhance medication persistence and compliance in patients with overactive bladder: a 24 weeks, randomised, open-label, multi-center trial.

ABSTRACT

OBJECTIVES: Anticholinergics are currently the mainstay for the management of overactive bladder (OAB). However, low drug adherence has been noted with these medications. The aim of this study was to determine whether a health education intervention (HEI) could improve drug persistence with anticholinergics in OAB patients. METHODS: We enrolled 682 OAB patients who were randomly distributed into either the HEI plus fesoterodine (HEI) group or the fesoterodine alone (control) group. The HEI consists of four education sections understanding OAB disease, dietary control, bladder training and understanding anticholinergics. The primary end-point was the difference in drug persistence between the HEI and control groups at 24 weeks. Persistence was defined as a gap ≤ 30 days between successive prescription pills. RESULTS: Among the 682 patients, 210 (30.8%) completed 24 weeks of study. Persistence of the HEI group at 6 months was not statistically higher than that of the control group (40.4% vs. 34.9%, p = 0.181). Compliance at 6 months was also similar between the two groups (38.5% vs. 32.5%, p = 0.128). Using OAB symptom score questionnaire, the efficacy of the two groups was not different at each follow-up (p > 0.05). The global response was similar between the two groups. However, the HEI group was more satisfied with treatment than the control group (p = 0.034). The most common reason for discontinuation was satisfaction with the treatment so that they did not need to follow-up, followed by inadequate efficacy in both groups. Adverse events were reported in 12.3% of patients. CONCLUSIONS: The health education intervention was not effective to increase drug persistence in OAB patients on anticholinergics.