Tolterodine Treatment Improves Storage Symptoms Suggestive of Overactive Bladder in Men Treated With α-Blockers

Abstract

BackgroundSome men receiving α-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB). ObjectiveTo evaluate the efficacy of tolterodine extended release (ER) in men on α-blocker therapy. Design, setting, and participantsThis double-blind trial included men aged ≥40 yr with frequency, urgency, and at least moderate problems reported on the Patient Perception of Bladder Condition (PPBC), despite being on a stable dose of α-blocker for ≥1 mo. InterventionsSubjects were randomized to tolterodine ER 4mg per day or placebo for 12 wk while continuing their prescribed α-blocker therapy. MeasurementsAt baseline and week 12, subjects completed the PPBC, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), and 5-d bladder diaries using the five-point Urinary Sensation Scale (USS). Frequency–urgency sum was defined as the sum of USS ratings for all micturitions. Results and limitationsPPBC improvement from baseline to week 12 was reported by 63.6% and 61.6% of subjects receiving tolterodine ER plus α-blocker and placebo plus α-blocker, respectively; this treatment difference, which was the primary end point, was not statistically significant (p>0.6699). At week 12, subjects receiving tolterodine ER plus α-blocker had significantly greater improvements versus placebo plus α-blocker in 24-h micturitions (−1.8 vs −1.2; p=0.0079) and daytime micturitions (−1.3 vs −0.8; p=0.0123); 24-h urgency episodes (−2.9 vs −1.8; p=0.0010), daytime urgency episodes (−2.2 vs −1.4; p=0.0017), and nocturnal urgency episodes (−0.5 vs −0.3; p=0.0378); frequency–urgency sum (−7.8 vs −5.1; p=0.0065); IPSS storage subscale (−2.6 vs −2.1; p=0.0370); and OAB-q symptom bother scale (−17.9 vs −14.4; p=0.0086) and coping domain (15.4 vs 12.4; p=0.0491). Acute urinary retention requiring catheterization occurred in <1% of either group. There were no clinically meaningful changes in postvoid residual volume or maximum urinary flow rate. ConclusionsMen with bothersome OAB symptoms despite continued α-blocker therapy showed significantly greater improvements in diary variables, IPSS Storage scores, and symptom bother when receiving additional tolterodine ER versus placebo plus α-blocker.