Safety and efficacy of tolterodine extended release in men with overactive bladder symptoms and presumed non-obstructive benign prostatic hyperplasia.
Patients with presumed non-obstructive BPH (Q (max )>or= 15 ml/s) treated with tolterodine ER 4 mg/day for OAB symptoms, alone or added to unsuccessful alpha-blocker treatment of >or=6 weeks duration, were observed for 12 weeks in a non-interventional study to generate real-life efficacy and safety data. Patients completed the IPSS, the OAB-q and a 2-day micturition diary at baseline and 12 weeks. PVR was determined sonographically. Seven hundred and forty one patients were analysed. Mean PVR did not increase (25.4 +/- 26.5 vs. 29.3 +/- 30.9 ml at baseline). AUR requiring catheterization occurred in two patients, acute UTI in four patients. Median IPSS total scores decreased from 17 to 10, IPSS QoL scores from 4 to 2, OAB-q symptom bother scores from 50.0 to 22.5 and OAB-q HRQL scores increased from 59.2 to 81.6. In men with OAB symptoms and presumed non-obstructive BPH, tolterodine ER provided considerable symptomatic and QoL improvements with a low risk of AUR, acute UTI, or increased PVR.
Höfner
K
K
Urologische Klinik, Evangelisches Krankenhaus Oberhausen, Virchowstrasse 20, 46047 Oberhausen, Germany. klaus.hoefner@freenet.de
Burkart
M
M
Jacob
G
G
Jonas
U
U
D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D003408:Cresols / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D010665:Phenylpropanolamine / Q000008:administration & dosage* / Q000009:adverse effects; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012044:Regression Analysis; D012720:Severity of Illness Index; D000068737:Tolterodine Tartrate; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000523:psychology; D053202:Urinary Incontinence, Urge / Q000188:drug therapy / Q000523:psychology; D014563:Urodynamics
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate