Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms
NCT ID: NCT01457573
Last Updated: 2018-04-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2011-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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One (single arm)
All men will receive morning dosing with Tamsulosin (Flomax) 0.4 mg (1 tab) and Solifenacin (Vesicare) 5 mg (1 tab) orally at the same time.
Tamsulosin
Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®).
Solifenacin
Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.
Interventions
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Tamsulosin
Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®).
Solifenacin
Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* International Prostate Symptom Score (IPSS) \> 8
* PSA \< 10 ng/ml (negative biopsies within 6 months for any age-specific PSA elevation suspicious for prostate carcinoma)
* Post void residual urine \< 150 mls
* Urinary Flow rate \> 15 mL/sec
Exclusion Criteria
* Urinary tract infection, Urinary stone(s), Urinary tract tumor
* Radiation therapy for urologic malignancy or prostate surgery; radiation to pelvic, colon, rectum, prostate, bladder, uterus or ovaries
* Alpha blocker therapy or anticholinergic therapy within 3 months of entry or 5 alpha reductase therapy within 18 months.
* History of cataracts with planned surgery
45 Years
MALE
No
Sponsors
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Astellas Pharma US, Inc.
INDUSTRY
Timothy Boone, MD, PhD
OTHER
Responsible Party
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Timothy Boone, MD, PhD
Sponsor-Investigator/Principal Investigator
Principal Investigators
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Timothy Boone, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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The Methodist Hospital System
Houston, Texas, United States
Countries
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References
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McVary KT. 2010 AUA Benign Prostatic Hyperplasia Clinical Guidelines. Panel Chair, AUA News 2010; 15 (3) 10 - 11.
Chapple CR, Roehrborn CG. A shifted paradigm for the further understanding, evaluation, and treatment of lower urinary tract symptoms in men: focus on the bladder. Eur Urol. 2006 Apr;49(4):651-8. doi: 10.1016/j.eururo.2006.02.018. Epub 2006 Feb 17.
Kaplan SA. New data on Tolterodine: Do recent findings dispel questions about treating overactive bladder in men? Eur Urology 2007; Suppl 6: 10-16.
Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004 Oct;94(6):817-20. doi: 10.1111/j.1464-410X.2004.05039.x.
Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2319-28. doi: 10.1001/jama.296.19.2319.
Kaplan SA, Roehrborn CG, Chancellor M, Carlsson M, Bavendam T, Guan Z. Extended-release tolterodine with or without tamsulosin in men with lower urinary tract symptoms and overactive bladder: effects on urinary symptoms assessed by the International Prostate Symptom Score. BJU Int. 2008 Nov;102(9):1133-9. doi: 10.1111/j.1464-410X.2008.07761.x. Epub 2008 May 26.
Kaplan SA, Goldfischer ER, Steers WD, Gittelman M, Andoh M, Forero-Schwanhaeuser S. Solifenacin treatment in men with overactive bladder: effects on symptoms and patient-reported outcomes. Aging Male. 2010 Jun;13(2):100-7. doi: 10.3109/13685530903440408.
Liu HT, Kuo HC. Urinary nerve growth factor level could be a potential biomarker for diagnosis of overactive bladder. J Urol. 2008 Jun;179(6):2270-4. doi: 10.1016/j.juro.2008.01.146. Epub 2008 Apr 18.
Yokoyama T, Kumon H, Nagai A. Correlation of urinary nerve growth factor level with pathogenesis of overactive bladder. Neurourol Urodyn. 2008;27(5):417-20. doi: 10.1002/nau.20519.
Liu HT, Chancellor MB, Kuo HC. Decrease of urinary nerve growth factor levels after antimuscarinic therapy in patients with overactive bladder. BJU Int. 2009 Jun;103(12):1668-72. doi: 10.1111/j.1464-410X.2009.08380.x. Epub 2009 Feb 11.
Jacobs BL, Smaldone MC, Tyagi V, Philips BJ, Jackman SV, Leng WW, Tyagi P. Increased nerve growth factor in neurogenic overactive bladder and interstitial cystitis patients. Can J Urol. 2010 Feb;17(1):4989-94.
Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
Dmochowski RR, Gomelsky A. Overactive bladder in males. Ther Adv Urol. 2009 Oct;1(4):209-21. doi: 10.1177/1756287209350383.
Other Identifiers
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IRB# 0711-0124
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00006253
Identifier Type: -
Identifier Source: org_study_id
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