Soonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, 420-767, South Korea
NCT Number: NCT01533597
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).
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Notify Me20 year–70 year
Female
Interventional
Phase 4
Bucheon-si, Gyeonggi-do, 420-767, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Solifenacin (5mg, qd, oral)
Other names: Vesicare
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
Other names: Vesicare, Harnal
Time frame: at week 24 relative to baseline
Time frame: at week 24 relative to baseline
Time frame: at week 24 relative to baseline
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
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 from baseline in Post-Void Residual (PVR) volume
Time frame: at week 24 relative to baseline
maximal urinary flow rate (Qmax) assessed by uroflowmetry
Soonchunhyang University Hospital
Other
Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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