The aim of the study is to investigate if the combination therapy consisting of anticholinergics plus alpha-blockers could be beneficial for women suffering from Overactive Bladder (OAB).
Overactive bladder (OAB) describes the symptom complex of urgency, with or without urge incontinence, usually with frequency and nocturia. The lower urinary tract is innervated by both the parasympathetic and the sympathetic nervous system, that act via muscarinic and adrenergic receptors, respectively. Antimuscarinics are mainly used for the treatment of patients with OAB, especially women. Other than antimuscarinics, a1-blockers have been shown in several clinical reports to be useful in treating DO caused by neurological diseases.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Solifenacin (5mg, qd, oral)
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Change in Mean Number of Micturition Episodes Per 24 Hours
Time frame: at week 24 relative to baseline
Numeric Change of Urgency Episodes Per 24 Hours
Time frame: at week 24 relative to baseline
Change in Total Score of OABSS
Total Score of OABSS(Overactive Bladder Symptom Score) is the sum of 4 questions, ranging from 0 (best possible outcome) to 15 (worst possible outcome)
Time frame: at week 24 relative to baseline
Change in Score of IPSS
Total Score of IPSS(International Prostate Symptom Score) is the sum of 7 questions, ranging from 0 (best possible outcome) to 35 (worst possible outcome). The 7 symptom questions include feeling of incomplete bladder emptying, frequency, intermittency, urgency, weak stream, straining and nocturia, each referring to during the last month, and each involving assignment of a score from 0 to 5 for a total of maximum 35 points.
Time frame: at week 24 relative to baseline
Change of PVR
Change from baseline in Post-Void Residual (PVR) volume
Time frame: at week 24 relative to baseline
Change of Qmax
maximal urinary flow rate (Qmax) assessed by uroflowmetry
Time frame: at week 24 relative to baseline
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