The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)
|Overactive Bladder||Drug: Solifenacin Drug: Solifenacin plus Tamsulosin||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparison of the Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With OAB: A Prospective Randomized Multicenter Study|
- 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 [ 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)
- Change in Score of IPSS [ 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.
- Change of PVR [ Time Frame: at week 24 relative to baseline ]Change from baseline in Post-Void Residual (PVR) volume
- Change of Qmax [ Time Frame: at week 24 relative to baseline ]maximal urinary flow rate (Qmax) assessed by uroflowmetry
|Study Start Date:||December 2010|
|Study Completion Date:||February 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Solifenacin||
Solifenacin (5mg, qd, oral)
Other Name: Vesicare
|Experimental: Solifenacin plus Tamsulosin||
Drug: Solifenacin plus Tamsulosin
Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533597
|Korea, Republic of|
|Soonchunhyang University Bucheon Hospital|
|Bucheon, Gyeonggi-do, Korea, Republic of, 420-767|
|Principal Investigator:||Kwang Woo Lee, Ph.D||Soonchunhyang University Hospital|