Efficacy and safety of tolterodine extended release and dutasteride in male overactive bladder patients with prostates >30 grams.

OBJECTIVES

To assess safety and efficacy of 4 mg tolterodine extended release (TER) with 0.5 mg dutasteride (DUT) in men with persistent overactive bladder (OAB) symptoms and lower urinary tract symptoms (LUTS) unsuccessfully treated with DUT alone. TER is indicated for OAB and DUT is indicated for LUTS from benign prostatic hyperplasia.

METHODS

A total of 51 men treated with DUT for >or=6 months with persistent OAB symptoms enrolled in a 12-week, open-label study, and given TER (4 mg q.h.s.). Inclusion criteria were international prostate symptom score (IPSS) >or=12, IPSS quality-of-life item >or=3, significant bother, frequency (>or=8 voids/24 h), and urgency (>or=3 episodes/24 h). Visits occurred at 4, 8, and 12 weeks. Efficacy was assessed by changes in diary endpoints and IPSS (total, storage, and voiding). Safety was assessed by changes in postvoid residual, peak flow rate (Q(max.)), adverse events, and retention.

RESULTS

Baseline prostate volume was 54.3 mL. TER significantly reduced frequency and urgency: 24-hour micturition frequency (-3.2, P <.02), OAB episodes (19.2%, P <.03), severe OAB episodes (71.4%, P <.05), and nighttime voiding (-0.9, P <.003). IPSS decreased with DUT (19.3-14.3) and decreased with addition of TER to 7.1 (P <.001). Storage symptoms decreased from 9.8 to 4.5 (P <.001). Dry mouth occurred in 4 (7.5%) subjects, constipation in 1 (2%), and decreased sexual function in 2 (3.9%) subjects. Postvoid residual increased by 4.2 mL, Q(max.) decreased by 0.2 mL/s, and no patients went into retention.

CONCLUSIONS

The combination TER and DUT was effective, safe, and well-tolerated in men with large prostates (>or=30 mL) with persistent OAB symptoms and LUTS secondary to benign prostatic hyperplasia.