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Eur Urol. 2009 Sep;56(3):534-41. doi: 10.1016/j.eururo.2008.11.026. Epub 2008 Nov 24.

Tolterodine treatment improves storage symptoms suggestive of overactive bladder in men treated with alpha-blockers.

Author information

  • 1Sheffield Teaching Hospitals, Sheffield, UK. c.r.chapple@shef.ac.uk

Abstract

BACKGROUND:

Some men receiving alpha-blocker therapy for lower urinary tract symptoms report persistent storage symptoms suggestive of overactive bladder (OAB).

OBJECTIVE:

To evaluate the efficacy of tolterodine extended release (ER) in men on alpha-blocker therapy.

DESIGN, SETTING, AND PARTICIPANTS:

This double-blind trial included men aged > or = 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 alpha-blocker for > or = 1 mo.

INTERVENTIONS:

Subjects were randomized to tolterodine ER 4 mg per day or placebo for 12 wk while continuing their prescribed alpha-blocker therapy.

MEASUREMENTS:

At 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 LIMITATIONS:

PPBC improvement from baseline to week 12 was reported by 63.6% and 61.6% of subjects receiving tolterodine ER plus alpha-blocker and placebo plus alpha-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 alpha-blocker had significantly greater improvements versus placebo plus alpha-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.

CONCLUSIONS:

Men with bothersome OAB symptoms despite continued alpha-blocker therapy showed significantly greater improvements in diary variables, IPSS Storage scores, and symptom bother when receiving additional tolterodine ER versus placebo plus alpha-blocker.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00282932.

PMID:
19070418
DOI:
10.1016/j.eururo.2008.11.026
[PubMed - indexed for MEDLINE]
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