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Tolterodine extended release with or without tamsulosin in men with lower urinary tract symptoms including overactive bladder symptoms: effects of prostate size.
- Source :
-
European urology [Eur Urol] 2009 Feb; Vol. 55 (2), pp. 472-9. Date of Electronic Publication: 2008 Jun 17. - Publication Year :
- 2009
-
Abstract
- Background: Some men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms may benefit from antimuscarinic therapy, with or without an alpha-adrenergic antagonist.<br />Objectives: To evaluate the safety and efficacy of tolterodine extended release (ER), tamsulosin, or tolterodine ER+tamsulosin in men meeting symptom entry criteria for OAB and prostatic enlargement trials, stratified by prostate size.<br />Design, Setting, and Participants: Subjects with an International Prostate Symptom Score (IPSS) >or=12; frequency and urgency, with or without urgency urinary incontinence; postvoid residual volume (PVR) <200 mL; and maximum urinary flow rate (Q(max)) >5 mL/s were randomized to receive placebo, tolterodine ER (4 mg), tamsulosin (0.4 mg), or tolterodine ER+tamsulosin for 12 wk. Data were stratified by median baseline prostate volume (<29 mL vs >or=29 mL).<br />Measurements: Endpoints included week 12 changes in bladder diary variables, IPSS scores, and safety variables.<br />Results and Limitations: Among men with larger prostates, tolterodine ER+tamsulosin significantly improved frequency (p=0.001); urgency (p=0.006); and IPSS total (p=0.001), storage (p<0.001), and voiding scores (p<0.013). Tamsulosin significantly improved IPSS voiding scores (p=0.030). Among men with smaller prostates, tolterodine ER significantly improved frequency (p=0.016), UUI episodes (p=0.036), and IPSS storage scores (p=0.005). Tolterodine ER+tamsulosin significantly improved frequency (p=0.001) and IPSS storage scores (p=0.018). Tamsulosin significantly improved nocturnal frequency (p=0.038) and IPSS voiding (p=0.036) and total scores (p=0.044). There were no clinically or statistically significant changes in Q(max) or PVR; incidence of acute urinary retention (AUR) was low in all groups (<or=2%).<br />Conclusions: Men with smaller prostates and moderate-to-severe LUTS including OAB symptoms benefited from tolterodine ER. Therapy with tolterodine ER+tamsulosin was effective regardless of prostate size. Tolterodine ER, with or without tamsulosin, was well tolerated and not associated with increased incidence of AUR.
- Subjects :
- Adult
Benzhydryl Compounds administration & dosage
Cresols administration & dosage
Delayed-Action Preparations administration & dosage
Delayed-Action Preparations therapeutic use
Diuresis drug effects
Drug Therapy, Combination
Humans
Male
Middle Aged
Multicenter Studies as Topic
Muscarinic Agonists administration & dosage
Organ Size
Phenylpropanolamine administration & dosage
Prostate drug effects
Randomized Controlled Trials as Topic
Tamsulosin
Tolterodine Tartrate
Urinary Retention epidemiology
Adrenergic alpha-Antagonists therapeutic use
Benzhydryl Compounds therapeutic use
Cresols therapeutic use
Muscarinic Agonists therapeutic use
Phenylpropanolamine therapeutic use
Prostate anatomy & histology
Sulfonamides therapeutic use
Urinary Bladder, Overactive drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1873-7560
- Volume :
- 55
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- European urology
- Publication Type :
- Academic Journal
- Accession number :
- 18583022
- Full Text :
- https://doi.org/10.1016/j.eururo.2008.06.032