Flavoxate treatment of micturition disorders accompanying benign prostatic hypertrophy: a double-blind placebo-controlled multicenter investigation.
To investigate the effect of flavoxate (Urispadol) treatment on patients with symptomatic benign prostatic hypertrophy (BPH), with the main weight on the irritative symptoms, a randomized, double-blind, parallel-group, placebo-controlled and multicenter investigation was carried out. Seventy patients entered the study, 37 were allocated to flavoxate treatment on a daily dose of 1,200 mg (400 mg t.i.d.) for 12 weeks, and 33 patients were allocated to placebo treatment. In spite of a sufficient power, the study did not discriminate the two treatment groups in a statistically significant way (p > 0.05), when considering the main endpoints: the irritative symptom score and the global patient evaluation. Conservative treatment of micturition disorders accompanying BPH with flavoxate in doses of 1,200 mg/day cannot be recommended for clinical use.
Dahm
T L
TL
Urological Department, Gentofte Hospital, Denmark.
Ostri
P
P
Kristensen
J K
JK
Walter
S
S
Frimodt-Møller
C
C
Rasmussen
R B
RB
Nøhr
M
M
Alexander
N
N
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D005422:Flavoxate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010276:Parasympatholytics / Q000009:adverse effects / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000150:complications*; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology
D010276:Parasympatholytics; D005422:Flavoxate