Abstract | CONTEXT: OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind, placebo-controlled trial conducted at 95 urology clinics in the United States involving men 40 years or older who had a total International Prostate Symptom Score of 12 or higher and, an International Prostate Symptom Score quality-of-life (QOL) item score of 3 or higher, a self-rated bladder condition of at least moderate bother, and a bladder diary documenting micturition frequency (>or=8 micturitions per 24 hours) and urgency (>or=3 episodes per 24 hours), with or without urgency urinary incontinence. Patients were recruited between November 2004 and February 2006, and the study was completed May 2006. INTERVENTIONS: MAIN OUTCOME MEASURES: Patient perception of treatment benefit, bladder diary variables, International Prostate Symptom Scores, and safety and tolerability were assessed. RESULTS: A total of 172 men (80%) receiving tolterodine ER plus tamsulosin reported treatment benefit by week 12 compared with 132 patients (62%) receiving placebo (P<.001), 146 (71%) receiving tamsulosin (P=.06 vs placebo), or 135 (65%) receiving tolterodine ER (P=.48 vs placebo). Patients receiving tolterodine ER plus tamsulosin compared with placebo experienced significant reductions in urgency urinary incontinence (-0.88 vs -0.31, P=.005), urgency episodes without incontinence (-3.33 vs -2.54, P=.03), micturitions per 24 hours (-2.54 vs -1.41, P<.001), and micturitions per night (-0.59 vs -0.39, P.02). Patients receiving tolterodine ER plus tamsulosin demonstrated significant improvements on the total International Prostate Symptom Score (-8.02 vs placebo, -6.19, P=.003) and QOL item (-1.61 vs -1.17, P=.003). All interventions were well tolerated. The incidence of acute urinary retention requiring catheterization was low ( tolterodine ER plus tamsulosin, 0.4%; tolterodine ER, 0.5%; tamsulosin, 0%; and placebo, 0%). CONCLUSIONS:
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Authors | Steven A Kaplan, Claus G Roehrborn, Eric S Rovner, Martin Carlsson, Tamara Bavendam, Zhonghong Guan |
Journal | JAMA
(JAMA)
Vol. 296
Issue 19
Pg. 2319-28
(Nov 15 2006)
ISSN: 1538-3598 [Electronic] United States |
PMID | 17105794
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Adrenergic alpha-Antagonists
- Benzhydryl Compounds
- Cresols
- Delayed-Action Preparations
- Muscarinic Antagonists
- Sulfonamides
- Phenylpropanolamine
- Tolterodine Tartrate
- Tamsulosin
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Topics |
- Adrenergic alpha-Antagonists
(therapeutic use)
- Adult
- Aged
- Aged, 80 and over
- Benzhydryl Compounds
(therapeutic use)
- Cresols
(therapeutic use)
- Delayed-Action Preparations
- Double-Blind Method
- Drug Therapy, Combination
- Humans
- Male
- Middle Aged
- Muscarinic Antagonists
(therapeutic use)
- Phenylpropanolamine
(therapeutic use)
- Prostatic Hyperplasia
(drug therapy)
- Sulfonamides
(therapeutic use)
- Tamsulosin
- Tolterodine Tartrate
- Urinary Bladder, Overactive
(drug therapy)
- Urinary Incontinence, Urge
(drug therapy)
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