Fesoterodine Treatment for Overactive Bladder in Older Women With and Without Hypertension

Metabolic diseases, including hypertension (HT), diabetes mellitus, and hyperlipidemia, have been identified as risk factors for the development of lower urinary tract symptoms. In addition, the majority of patients with overactive bladder (OAB) are elderly, have comorbidities, and take concomitant medications. 

Researchers from Japan assessed the efficacy and safety of fesoterodine vs placebo (PBO) in elderly females with OAB symptoms, including urgeny urinary incontinence (UUI) and with or without concomitant HT in a post-hoc analysis.

The efficacy and safety of fesoterodine (4 mg or 8 mg) vs PBO were assessed using pooled data from ten 12-week, double-blind, PBO-controlled, parallel-group studies. The study population consisted of female participants aged 65  and older with OAB symptoms for a minimum of 6 months and reporting > 0 UUI episodes per 24 hours at baseline.

Of the 2527 eligible elderly female patients with OAB symptoms, including UUI, 1523 patients (60.3%) had a medical history of HT, and 1004 patients (39.7%) had no history of HT. Mean body weight, body mass index, and OAB symptom values at baseline were significantly higher in patients with HT than in those without HT (all P < .05). The improvements from baseline to week 12 in all OAB symptoms with fesoterodine were significantly greater than PBO in both elderly females with HT and those without HT (all P < .05). 

The proportion of elderly females who were dry (no UUI episodes) and the proportion who had < 8 micturitions at week 12 were statistically significantly greater with fesoterodine vs PBO in both patient populations. OAB symptom bother, health-related quality of life outcomes, and Patient Perception of Bladder Condition scores also were statistically significantly improved with fesoterodine vs PBO in elderly females with or without HT.

The incidence of treatment-related adverse events in the fesoterodine group was not higher in elderly women with HT (39.3%) than in those without HT (44.6%). In elderly females treated with fesoterodine, dry mouth and constipation were the most common treatment-related adverse events in those with HT (26.2% and 5.2%, respectively) and those without HT (30.5% and 8.0%, respectively). 

Overall, fesoterodine demonstrated significantly greater efficacy vs PBO in reducing UUI episodes, micturitions, nocturnal micturitions, and urgency episodes per 24 hours from baseline to week 12 in both elderly females with HT and those without HT. Patient-reported OAB symptom bother and health-related quality of life outcomes also demonstrated significantly greater improvements with fesoterodine vs PBO in elderly females with HT or without HT. —Amanda Del Signore