Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruction: a prospective, randomized, controlled multicenter study.
OBJECTIVE
We evaluated the efficacy and safety of a therapeutic modality involving propiverine combined with doxazosin in patients with overactive bladder (OAB) and benign prostatic obstruction.


METHODS
Men 50 years or older with OAB symptoms and urodynamically proven bladder outlet obstruction (Abrams-Griffith score greater than 20) were randomized (1:2) into 2 groups, namely group 1-doxazosin controlled release gastrointestinal therapeutic system formulation (4 mg once daily) only and group 2-propiverine hydrochloride (20 mg once daily) plus doxazosin controlled release gastrointestinal therapeutic system formulation for an 8-week treatment regimen.


RESULTS
A total of 211 men, including 69 in group 1 and 142 in group 2, were treated and 198 (93.8%) completed the 8 weeks of treatment. Significant improvements were noted in each group after treatment in urinary frequency, maximum flow rate, average micturition volume and International Prostate Symptom Score. Compared with group 1 improvement rates with regard to urinary frequency (23.5% vs 14.3%, p = 0.004), average micturition volume (32.3% vs 19.2%, p = 0.004), and storage (41.3% vs 32.6%, p = 0.029) and urgency (p = 0.019) International Prostate Symptom Score symptoms were more significant in group 2. Post-void residual urine was found to be significantly increased only in group 2 but this was not accompanied by urinary retention. Patient satisfaction rates were found to be significantly higher in group 2 than in group 1 (p = 0.002). Overall adverse event rates were higher in group 2 (p = 0.002), although discontinuation rates and discontinuation rates due to adverse events were not different between the 2 groups.


CONCLUSIONS
This study reveals that combination therapy consisting of alpha1-adrenoceptor antagonists with antimuscarinics represents an effective and relatively safe treatment modality in select patients with OAB coexisting with benign prostatic obstruction.
Lee
Kyu-Sung
KS
Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Korea.
Choo
Myung-Soo
MS
Kim
Duk-Yoon
DY
Kim
Joon Chul
JC
Kim
Hyung-Jee
HJ
Min
Kweon Sik
KS
Lee
Jong Bouk
JB
Jeong
Hee Jong
HJ
Lee
Tack
T
Park
Won Hee
WH
D000317:Adrenergic alpha-Antagonists / Q000008:administration & dosage*; D000368:Aged; D001561:Benzilates / Q000627:therapeutic use*; D015897:Comorbidity; D003692:Delayed-Action Preparations; D017292:Doxazosin / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000627:therapeutic use*; D010276:Parasympatholytics / Q000627:therapeutic use*; D017060:Patient Satisfaction; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D014549:Urinary Incontinence / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology
D000317:Adrenergic alpha-Antagonists; D001561:Benzilates; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010276:Parasympatholytics; C015586:propiverine; D017292:Doxazosin