NCT01824420|CompletedPhase 4DMCFDA Drug
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Sponsor study identifier
interventional
129
1 country
1
Study Start
March 2013
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)To investigate if oxybutynin ER adding on antimuscarinics is more effective than mono-antimuscarinic treatment for patients with refractory OAB
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Actual (reported)April 1, 2013
Actual (reported)April 4, 2013
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points
Efficacy: Change from Baseline in the Perception of Bladder Condition (PPBC) at different time points (1 month, 2 months and 3 months). If patients have a PPBC improved by two scales, they are considered as successfully treated, otherwise failed treatment. Safety: Systemic adverse events such as difficult urination, dry mouth, dry eye, blurred vision, constipation, dizziness or general weakness
1 month, 2 months and 3 months
Change from Baseline in the Overactive Bladder Symptom Score (OABSS) at different time points
1 month, 2 months and 3 months
Change from Baseline in the urinary sensation scale (USS) at different time points
1 month, 2 months and 3 months
Change from Baseline in the International Prostate Symptom Score (IPSS) at different time points
1 month, 2 months and 3 months
Change from Baseline in the maximum flow rate (Qmax) at different time points
1 month, 2 months and 3 months
Change from Baseline in the voided volume at different time points
1 month, 2 months and 3 months
Tolterodine (Detrusitol) 4mg QD and Oxybutynin (Ditropan) ER 5mg QD
Tolterodine (Detrusitol) 4mg QD
Study group
Control group
Buddhist Tzu Chi General Hospital
Hualien City, 970, Taiwan
Abrams P, Kelleher CJ, Kerr LA, Rogers RG. Overactive bladder significantly affects quality of life. Am J Manag Care. 2000 Jul;6(11 Suppl):S580-90.
Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000 May;55(5A Suppl):33-46; discussion 50. doi: 10.1016/s0090-4295(99)00492-6.
Yiangou Y, Facer P, Ford A, Brady C, Wiseman O, Fowler CJ, Anand P. Capsaicin receptor VR1 and ATP-gated ion channel P2X3 in human urinary bladder. BJU Int. 2001 Jun;87(9):774-9. doi: 10.1046/j.1464-410x.2001.02190.x.
Hann-Chorng Kuo, M.D.
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
129 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2013
First Posted
April 4, 2013
Study Start
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Apostolidis A, Popat R, Yiangou Y, Cockayne D, Ford AP, Davis JB, Dasgupta P, Fowler CJ, Anand P. Decreased sensory receptors P2X3 and TRPV1 in suburothelial nerve fibers following intradetrusor injections of botulinum toxin for human detrusor overactivity. J Urol. 2005 Sep;174(3):977-82; discussion 982-3. doi: 10.1097/01.ju.0000169481.42259.54.
Simpson LL. Kinetic studies on the interaction between botulinum toxin type A and the cholinergic neuromuscular junction. J Pharmacol Exp Ther. 1980 Jan;212(1):16-21.
Kuo HC. Urodynamic evidence of effectiveness of botulinum A toxin injection in treatment of detrusor overactivity refractory to anticholinergic agents. Urology. 2004 May;63(5):868-72. doi: 10.1016/j.urology.2003.12.007.
Kuo HC. Comparison of effectiveness of detrusor, suburothelial and bladder base injections of botulinum toxin a for idiopathic detrusor overactivity. J Urol. 2007 Oct;178(4 Pt 1):1359-63. doi: 10.1016/j.juro.2007.05.136. Epub 2007 Aug 16.
March 2013
Actual (reported)Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
March 8, 2017
Record last verified: 2017-03
IPD cannot be released unless approval by the Ethics Committee of the Buddhist Tzu Chi General Hospital, Hualien, Taiwan
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Source: ClinicalTrials.gov.
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